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Impact Analytical

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Midland, Michigan, US

About Impact Analytical

Founded: 1995 Type: Privately Held Size: 11-50 employees

For every organization and industry, success hinges on the factors that can make a major impact: product quality and performance. That’s where we come in.

Impact Analytical is a full-service contract testing laboratory working with more than 300 companies around the world and dedicated to providing... Show more »

For every organization and industry, success hinges on the factors that can make a major impact: product quality and performance. That’s where we come in.

Impact Analytical is a full-service contract testing laboratory working with more than 300 companies around the world and dedicated to providing comprehensive analytical services in a variety of industries—pharmaceutical, plastics, consumer products, medical devices, packaging, automotive and specialty chemical.

All of our senior staff hold bachelor’s, master’s or Ph.D.s and are committed to analytical excellence. For us, nothing piques our interest like a fresh puzzle to engage our scientific discipline and routine. It is why our laboratories are equipped with the most up-to-date equipment. It is why we are willing to develop and validate new methods to get your answers.

Deformulation to material characterization, stability studies to actives quantitation, bring us your needs. Nothing satisfies our team like the successful arrival at a solid conclusion.

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Our Services (100)


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USP Testing

Price on request

Is your plastic material suitable for pharmaceutical use?

As of May 2016, a revision in the U.S. Pharmacopeia’s monograph for <661> changes the requirements for the testing of polymeric materials used for pharmaceutical packaging. The updated monograph has been divided into <661.1>, “Plastic Materials of Construction,” and... Show more »

Is your plastic material suitable for pharmaceutical use?

As of May 2016, a revision in the U.S. Pharmacopeia’s monograph for <661> changes the requirements for the testing of polymeric materials used for pharmaceutical packaging. The updated monograph has been divided into <661.1>, “Plastic Materials of Construction,” and <661.2> “Plastic Packaging Systems for Pharmaceutical Use.” In order that a plastic material be considered suitable for pharmaceutical use, it should be thoroughly characterized. While not all polymers are cited specifically in the monograph, those that are most commonly used in the pharmaceutical industry for packaging systems. Plastic materials of construction not included in this list must be characterized with the same intent. The evaluation of a polymer material of construction according to USP <661.1> is extensive, and includes identification, physico-chemical testing, biological reactivity, additives analysis, and extractable metals.

Plastic Packaging Systems include any container, whether it is bag, bottle, syringe, or inhaler, which comes into direct or indirect contact with the drug product. Evaluation of a plastic packaging system according to USP <661.2> includes biological reactivity, and physicochemical testing. A chemical safety assessment of the plastic packaging system should also be considered, and this could be accomplished through extractables and leachables testing.

Impact Analytical has the expertise and experience to evaluate your polymer material and container in compliance with USP <661>. From extraction, to analysis, to data evaluation, you can have confidence that your study will meet with USP and cGMP quality standards.

Impact Analytical is uniquely suited to perform the polymer characterization and quantitative additive analysis required to demonstrate that the raw materials are compliant with <661.1> and to ensure that the systems and packaged products that are formed from these materials meet the requirements of <661.2>.

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EI-MS

Electron Impact Mass Spectrometry
Price on request

Direct Probe EI-MS Testing Services

Impact Analytical provides direct probe EI-MS testing services on a wide range of materials for many different applications. Electron Ionization Mass Spectrometry is used to introduce low vapor pressure liquid solids to the mass spectrometer. Lower temperature requirements readily allow... Show more »

Direct Probe EI-MS Testing Services

Impact Analytical provides direct probe EI-MS testing services on a wide range of materials for many different applications. Electron Ionization Mass Spectrometry is used to introduce low vapor pressure liquid solids to the mass spectrometer. Lower temperature requirements readily allow analysis of temperature sensitive compounds. EI-MS analysis can also be used for a wide range of samples. Direct probe EI-MS spectra are compared to our database for identification of unknown compounds and impurities.

We have experience characterizing many different samples by EI-MS. Some of the projects we have recently performed include:

  • Molecular characterization by EI-MS analysis
  • Contaminant identification by EI-MS and CI-MS
  • Identification of unknown compounds by direct probe EI-MS
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Consumer Product Safety Testing

Price on request

Prohibited and Restricted Substances in the Home, Beauty, and Personal Care Market

Throughout the supply chain, the introduction of “harmful chemicals” or “substances of concern” must be controlled and where possible, eliminated. Through the introduction of regulations such as California’s Prop 65, the European Union’s REACH... Show more »

Prohibited and Restricted Substances in the Home, Beauty, and Personal Care Market

Throughout the supply chain, the introduction of “harmful chemicals” or “substances of concern” must be controlled and where possible, eliminated. Through the introduction of regulations such as California’s Prop 65, the European Union’s REACH initiative and the concerns related the potential health effects of BPA and Phthalates, the market has become more highly regulated, a complex situation for companies to navigate through. Manufacturers, distributors, and importers of personal care and beauty products must satisfy the regulations and guidelines for the control of contaminants and ingredients in products which are documented in both European and US guidelines.

The team at Impact Analytical has the experience and knowledge to meet the needs of our customers, developing cost effective procedures to get your product to market. Services include screening and testing of products for substances on the prohibited substances list, materials that can be used only in specified circumstances. Routine analysis services are available for a range of common contaminants including:

  • MEA/DEA/TEA
  • Ammonia
  • Fragrances (F&C)
  • Parabens
  • Triclosan
  • Benzalkonium Chloride
  • SLS/SLES
  • Acrylic Acid Polymers
  • Pthalates
  • Formaldehyde Carriers
  • Chlorine Bleach
  • Phenoxyethanol
  • 2-Butoxyethanol
  • Alcohol
  • Optical Brighteners
  • Phosphates
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Rheology Analysis

Price on request

Rheology is the study of the flow (strain rate) and deformation (strain) of materials, and provides information regarding how far a material moves when under a defined external force or stress. A rheometer can be used to measure Newtonian materials, which do not change with strain rate, as well as non-Newtonian materials where the... Show more »

Rheology is the study of the flow (strain rate) and deformation (strain) of materials, and provides information regarding how far a material moves when under a defined external force or stress. A rheometer can be used to measure Newtonian materials, which do not change with strain rate, as well as non-Newtonian materials where the viscosity changes with an applied strain rate. The technique can be used for liquids, 'soft solids' or solids under conditions in which they respond with plastic flow rather than deforming elastically in response to an applied force. The rheometer uses a specified geometry (such as cone and plate), a controlled temperature environment (such as a peltier plate), and a motor to apply a specified stress, strain or strain rate to the sample of interest.

Impact Analytical’s rheometer has been qualified for use in compliance with: U.S. Food and Drug Administration’s (FDA) current Good Manufacturing Practices (cGMP) Regulations, 21 CFR Parts 210 and 211, and the United States Pharmacopeia (USP).

Examples

Gel samples were obtained from a manufactured product. The viscosity of the gels were determined versus a specified strain rate under controlled temperature conditions. This information was used to assist in the manufacturing process.

A raw material was analyzed over a period of time under a specified temperature and strain rate to obtain a viscosity at specific time points. These data were used as acceptance criteria for the raw material.

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Molecular Weight Determination

Price on request

Molecular weight is critical property of a chemical, particularly for polymers. Impact Analytical has extensive experience and comprehensive tools for measuring molecular weight of all types of compounds and polymers. We can supply results to aid in problem solving, unknown identification, manufacturing support, or product... Show more »

Molecular weight is critical property of a chemical, particularly for polymers. Impact Analytical has extensive experience and comprehensive tools for measuring molecular weight of all types of compounds and polymers. We can supply results to aid in problem solving, unknown identification, manufacturing support, or product deformulation.

Depending on the sample material, molecular weight can be determined through a variety of techniques. Molecular weight, as well as molecular structure, of small molecules can be determined using mass spectrometry. Using a direct infusion method, samples can be introduced directly to the detector to confirm molecular weight of a known material, or provide structural characterization of an unknown.

Molecular weight information of polymers can be determined using techniques such as viscosity and size exclusion chromatography. In order to perform molecular weight determinations of polymers, it is necessary to understand the solubility of a given polymer.

Impact Analytical has state-of the-art equipment, and the knowledge and experience to provide you with molecular weight information of your sample material, whether it is a small molecule material or a polymer.

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Aerosol Testing

Price on request

Characterization of Aerosol Products for Labeling Compliance

Aerosol products are required to meet strict labeling guidelines with respect to flammability. These guidelines vary from country to country. Impact Analytical has experience with the labeling regulations in the US, Canada, and the EU. We can help determine which... Show more »

Characterization of Aerosol Products for Labeling Compliance

Aerosol products are required to meet strict labeling guidelines with respect to flammability. These guidelines vary from country to country. Impact Analytical has experience with the labeling regulations in the US, Canada, and the EU. We can help determine which labeling requirements apply to your product, what test methods must be followed, and what label must be applied based on the data (Non-flammable, Flammable, Highly Flammable, etc.).

Impact Analytical uses custom test stands set-up for determination of flame extension, ignition distance, and enclosed space ignition. We have a number of different flash point testers to accommodate the different published methods.. Our testing complies with all applicable ASTM, ISO, DIN, and EU guidelines.

Aerosol testing is performed under US, European, and Canadian regulations.

The US regulations are outlined in 16 CFR 1500.45, and describe the testing required to determine flame extension and flashback for self-pressurized containers.

The Canadian regulations for similar testing are outlined in “Consumer Chemicals and Containers Regulations, 2001 (SOR/2001-269), Schedule 1, “TEST FOR DETERMINING THE FLASHBACK AND THE LENGTH OF THE FLAME PROJECTION OF A FLAMMABLE PRODUCT ENCLOSED IN A SPRAY CONTAINER”.

The European regulations are outlined in UNECE Part III Classification Procedures, Test Methods and Criteria Relating to Class 2, Class 3, Class 4, Division 5.1, Class 8, and Class 9, Section 31. These regulations include testing requirements for enclosed space ignition, ignition distance, and aerosol foam flammability testing.

Flash point analysis is performed on the bulk liquid (rather than the final product with propellant) under various ASTM methods (ASTM D93, D3828, etc.).

Impact Analytical can provide you with accurate and reliable data for submitted consumer product samples, that complies with known U.S., Canadian, and European standards.

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BPA Testing

Bisphenol A Testing
Price on request

Quantitation of Bisphenol A (BPA)

The experts at Impact Analytical have experience testing for BPA in both simple and multipart matrices. We have developed extraction procedures that allow for the accurate quantitation of BPA in most plastic products in part-per-billion (ppb) concentrations and regularly develop custom... Show more »

Quantitation of Bisphenol A (BPA)

The experts at Impact Analytical have experience testing for BPA in both simple and multipart matrices. We have developed extraction procedures that allow for the accurate quantitation of BPA in most plastic products in part-per-billion (ppb) concentrations and regularly develop custom methods for the analysis of BPA in consumer products as well as other complex formulations. All analyses can be performed in support of filings with a variety of regulatory agencies including the FDA, EU and Health Canada or under ISO 9001:2015 quality standards.

Impact Analytical looks to partner with their customers to develop solutions that generate accurate and reliable data. Contact us today to discuss your BPA testing needs.

Why do I need to analyze for BPA?

Bisphenol A (BPA) is an endocrine disruptor that mimics estrogen. BPA is believed to be linked to health problems, from increased risk for cancers and alterations in fertility to obesity, diabetes and cognitive/behavorial deficits like ADHD. It is used in the production of polycarbonate plastic materials, epoxy resins used for coatings, printing inks and adhesives and can therefore be present in a variety of products including receipts, water bottles, dental fillings, syringes and food containers. The use of BPA in baby bottles is prohibited by the FDA, EU and Health Canada. Exposure to, and migration of, BPA in all other products is regulated by the State of California (Prop 65), the European Union (EU), the Food and Drug Administration (FDA) and Health Canada. The experts at Impact Analytical have extensive experience in developing methods to insure compliance with the appropriate regulations for your product.

California's Prop 65

California’s Office of Environmental Health Hazard Assessment (OEHHA) has added Bisphenol A (BPA) to the Proposition 65 list of chemicals known to the state to cause reproductive toxicity. The Developmental and Reproductive Toxicant Identification Committee (DARTIC), which serves as the “state’s qualified experts,” assessed BPA at a public meeting held on May 7, 2015. DARTIC concluded that BPA, through scientifically valid testing, caused reproductive toxicity.

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Chemical Deformulation and Reformulation

Price on request

Product deformulation and reverse engineering of consumer products, chemicals, and materials.

Impact Analytical has over 20 years of experience providing deformulation services on various types of products and materials. Our laboratory is equipped with the most advanced instrumentation to perform product deformulations (see... Show more »

Product deformulation and reverse engineering of consumer products, chemicals, and materials.

Impact Analytical has over 20 years of experience providing deformulation services on various types of products and materials. Our laboratory is equipped with the most advanced instrumentation to perform product deformulations (see infographic below). Example products that have been deformulated within our laboratory include:

  • Detergents
  • General purpose cleaners
  • Carpet cleaners
  • Hand and facial cleaners
  • Lotions
  • Shampoos
  • Medical device materials
  • Food container materials
  • Water bottles
  • Paper products (tissues, absorbent paper)

Impact Analytical is not limited to the above types of products and welcomes the challenges that your product may present.

The deformulation and reverse engineering process

When you work with us, our experts will first consult with you to discuss the objectives for the project and gather all available information about the product. Background information about the product can greatly aid in the reverse engineering process well as reduce the time required for the project. Our experts will work with you, and will work internally to develop the most efficient deformulation plan and to select the most appropriate techniques for the project.

Techniques used for the process

Advanced instrumentation is available at Impact Analytical for your sample analysis. This instrumentation includes LC-MS, GC-MS, NMR, FT-IR, ICP, and several other instruments. Most deformulation projects will require some separation of components within the sample. LC-MS is routinely used to separate and identify less volatile components in the sample, and GC-MS is routinely used to identify the more volatile components in the mixture. Our LC-MS can provide accurate mass information on components in the sample, which leads to timely assignments for the components in the product. Other techniques are also used as needed to provide a complete deformulation. Only the most appropriate techniques will be used for your project helping you to manage the cost of the project.

Final product

Impact Analytical will communicate with you during the deformulation process to ensure that your project objectives are met. Throughout the project, you will be able to determine whether or not your needs have been satisfied and to determine if additional testing is required for a complete deformulation. A quality deformulation will be the end product of our testing.

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Impurity Analysis

Price on request

Isolation and identification of unknown components and impurities.

The presence of an unknown component or impurity at even trace levels can cause irreparable damage to a product, rendering it unusable depending on the product application. Impact Analytical can assist with the identification of impurities that are detected... Show more »

Isolation and identification of unknown components and impurities.

The presence of an unknown component or impurity at even trace levels can cause irreparable damage to a product, rendering it unusable depending on the product application. Impact Analytical can assist with the identification of impurities that are detected during the analysis of a product or that cause product performance issues, such as color bodies in a sample. Unknown components and impurities can appear from several sources. The full breadth of analytical capabilities at Impact Analytical and over 20 years of experience characterizing unknowns and impurities enable us to solve these tough problems. Our laboratory is equipped with the most advanced instrumentation to identify impurities. We have proven methodologies for specific material types that allow us to efficiently isolate and identify the component, ultimately determining the source of the impurity.

Unknown and impure materials can come from numerous sources, including:

  • Process contaminants
  • API and/or non-active component degradation
  • Oxidized polymer additives
  • Un-reacted monomers/oligomers
  • Product Containers (i.e., leachables)

The process for the identification of impurities

When you work with us, our experts will first consult with you to discuss the objectives for the project and gather any available information about the product. Background information about the product can greatly aid in the identification of the impurity as well as reduce the time required for the project. Our experts will work you and will work internally to develop the most efficient analysis plan and to select the most appropriate techniques for the project.

Techniques used for the process

Most impurity analyses will require some separation of components within the sample. Advanced instrumentation available at Impact Analytical can be used to separate sample components and to identify the impurity. Our instrumentation includes LC-MS, GC-MS, NMR, FT-IR, ICP, and several other instruments. LC-MS can provide accurate mass information on less volatile impurities, which leads to a timely structural assignment. LC-MS can also detect compounds without UV chromophores that would not be detected by HPLC-UV. GC-MS can detect more volatile components. Other techniques mentioned above can also be used for the identification once the impurity has been isolated. Only the most appropriated techniques will be used for the project helping you to manage the cost of the project.

Final product

Impact Analytical will communicate with you during the analytical process to ensure that your project objectives are met. Throughout the project you will be able to determine whether or not your needs have been satisfied and to determine if additional testing is required to satisfy your needs. A quality identification of the impurity of interest will be the end product of our testing

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Polymer Characterization

Price on request

Thermal Analysis and physical property testing are vital to understanding polymers and their characterization. Impact Analytical has the experience and knowledge to analyze polymer materials for a wide range of applications. Our laboratories are equipped with the most advanced instrumentation to characterize the thermal properties... Show more »

Thermal Analysis and physical property testing are vital to understanding polymers and their characterization. Impact Analytical has the experience and knowledge to analyze polymer materials for a wide range of applications. Our laboratories are equipped with the most advanced instrumentation to characterize the thermal properties of polymers, including glass transition (Tg), melt temperature (Tm), heat of fusion, heat capacity, weight loss, thermal stability, and more. We can also analyze the rheological properties of polymers and polymer systems. Contact us today to discuss your polymer characterization project.

Process

When you work with us, our experts will first consult with you to discuss in detail your analytical requirements. We will talk with you about the uses for the data and gather information about the polymers being analyzed, including type of polymer, filler type, any known additives, as well as presence of recycle material.

  • Impact Analytical provides a wide range of analyses for characterization of polymers including:
  • Thermal testing - DSC for such information as glass transition, melt temperature, oxidative induction time; and TGA for weight loss, thermal stability, inorganic content
  • Physical testing - density and hardness.
  • Rheological testing -capillary and rotational
  • Optical testing - color, haze, and gloss

Goals of the service /technique

Polymeric materials are used in many industries and understanding the thermal and physical properties of these materials is vital to the development and production of products. The property data can be used for quality control purposes, comparison of supplier materials, and design of production lines. These techniques can also be used to characterize unknown materials and polymer mixtures.

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Residual Solvent Analysis

Price on request

Organic solvents are used in manufacturing processes of products in all industries. Many of these solvents are harmful, and can be present in the final product as residuals from the manufacturing process. It is important, and in some industries required, that residual solvent levels are monitored in the final product. Impact... Show more »

Organic solvents are used in manufacturing processes of products in all industries. Many of these solvents are harmful, and can be present in the final product as residuals from the manufacturing process. It is important, and in some industries required, that residual solvent levels are monitored in the final product. Impact Analytical has the tools and experience to characterize products from all industries for residual solvents. Our experts can develop product specific methods, or utilize regulatory methods to identify and quantitate residual solvents to the lowest levels possible.

Examples of past projects include:

  • Quantitation of Residual Solvents in Medical Tubing
  • Quantitation of Residual Solvents using USP method <467>
  • Modification of USP <467> for use with water insoluble medical device
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ICP-AES/OES

Inductively Coupled Plasma Atomic Emission Spectroscopy/Optical Emission Spectroscopy
Price on request

Elemental and Trace Metals Analysis

Inductively Coupled Plasma – Optical Emission Spectroscopy (commonly known as ICP-OES), and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) are two popular techniques used in trace and ultra-trace elemental analysis. ICP-OES analysis is an excellent technique for identifying and... Show more »

Elemental and Trace Metals Analysis

Inductively Coupled Plasma – Optical Emission Spectroscopy (commonly known as ICP-OES), and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) are two popular techniques used in trace and ultra-trace elemental analysis. ICP-OES analysis is an excellent technique for identifying and quantifying elemental constituents in various sample matrices including polymers, pharmaceuticals, chemicals, solutions, plastics, metals, and consumer products. ICP-MS analysis provides ultra-trace elemental analysis to identify and quantitate elements down to the sub parts-per-billion range, while utilizing a dynamic collision cell to eliminate troublesome interferences.

With ICP-MS and ICP-OES capabilities, we can identify and quantify trace metals at percentage levels, as well as parts per million (ppm), parts per billion (ppb), and parts per trillion (ppt) levels by using established sample preparation techniques and analyses. Varying digestion techniques, including aqua regia, HF, as well as the use of hot plate digestion and microwave digestion for hard-to-digest materials allows our lab to get nearly any product into a solution where they can be analyzed for metals.

Impact Analytical quality program is certified to the ISO 9001:2008 system standard. Don’t have a method to use? Our experienced staff can perform method development and method validation to meet your specific needs. Our cGMP and GLP -compliant facility can administer elemental testing by ICP-OES and ICP-MS in compliance with ICH Q3D and USP Chapters <232> and <233>.

Examples of ICP analysis services provided by Impact Analytical:

  • Single or multi-element analysis
  • Heavy metals analysis
  • Impurity testing
  • Package testing for support of Extractables & Leachables studies
  • USP 232 and 233 testing
  • Analysis of Wax and Fragrance Samples
  • Lead content
  • Molecular Sieve analysis
  • Beauty and cosmetics samples
  • Medical devices
  • Identify unknowns
  • Many others (ask to see if we can perform your unique testing)

We can detect and measure the following trace and ultra-trace metals:

  • Aluminum, Antimony, Arsenic
  • Barium, Beryllium, Bismuth, Boron
  • Cadmium, Calcium, Chromium, Cobalt, Copper, Cerium, Cesium
  • Dysprosium
  • Europium, Erbium
  • Iron
  • Germanium, Gold, Gallium, Gadolinium
  • Hafnium, Holmium
  • Indium, Iridium
  • Lead, Lithium, Lanthanum, Lutetium
  • Magnesium, Manganese, Mercury, Molybdenum
  • Nickel, Neodymium, Niobium
  • Osmium
  • Palladium, Phosphorus, Platinum, Potassium, Praseodymium
  • Rhodium, Ruthenium, Rhenium, Rubidium
  • Selenium, Scandium, Silicon, Strontium, Sulfur, Silver, Sodium, Samarium
  • Tantalum, Tellurium, Thallium, Tin, Titanium, Tungsten, Thulium, Thorium, Terbium
  • Uranium
  • Vanadium
  • Ytterbium, Yttrium
  • Zinc, Zirconium
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ICP-MS

Inductively Coupled Plasma Mass Spectrometry
Price on request

Elemental and Trace Metals Analysis

Inductively Coupled Plasma – Optical Emission Spectroscopy (commonly known as ICP-OES), and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) are two popular techniques used in trace and ultra-trace elemental analysis. ICP-OES analysis is an excellent technique for identifying and... Show more »

Elemental and Trace Metals Analysis

Inductively Coupled Plasma – Optical Emission Spectroscopy (commonly known as ICP-OES), and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) are two popular techniques used in trace and ultra-trace elemental analysis. ICP-OES analysis is an excellent technique for identifying and quantifying elemental constituents in various sample matrices including polymers, pharmaceuticals, chemicals, solutions, plastics, metals, and consumer products. ICP-MS analysis provides ultra-trace elemental analysis to identify and quantitate elements down to the sub parts-per-billion range, while utilizing a dynamic collision cell to eliminate troublesome interferences.

With ICP-MS and ICP-OES capabilities, we can identify and quantify trace metals at percentage levels, as well as parts per million (ppm), parts per billion (ppb), and parts per trillion (ppt) levels by using established sample preparation techniques and analyses. Varying digestion techniques, including aqua regia, HF, as well as the use of hot plate digestion and microwave digestion for hard-to-digest materials allows our lab to get nearly any product into a solution where they can be analyzed for metals.

Impact Analytical quality program is certified to the ISO 9001:2008 system standard. Don’t have a method to use? Our experienced staff can perform method development and method validation to meet your specific needs. Our cGMP and GLP -compliant facility can administer elemental testing by ICP-OES and ICP-MS in compliance with ICH Q3D and USP Chapters <232> and <233>.

Examples of ICP analysis services provided by Impact Analytical:

  • Single or multi-element analysis
  • Heavy metals analysis
  • Impurity testing
  • Package testing for support of Extractables & Leachables studies
  • USP 232 and 233 testing
  • Analysis of Wax and Fragrance Samples
  • Lead content
  • Molecular Sieve analysis
  • Beauty and cosmetics samples
  • Medical devices
  • Identify unknowns
  • Many others (ask to see if we can perform your unique testing)

We can detect and measure the following trace and ultra-trace metals:

  • Aluminum, Antimony, Arsenic
  • Barium, Beryllium, Bismuth, Boron
  • Cadmium, Calcium, Chromium, Cobalt, Copper, Cerium, Cesium
  • Dysprosium
  • Europium, Erbium
  • Iron
  • Germanium, Gold, Gallium, Gadolinium
  • Hafnium, Holmium
  • Indium, Iridium
  • Lead, Lithium, Lanthanum, Lutetium
  • Magnesium, Manganese, Mercury, Molybdenum
  • Nickel, Neodymium, Niobium
  • Osmium
  • Palladium, Phosphorus, Platinum, Potassium, Praseodymium
  • Rhodium, Ruthenium, Rhenium, Rubidium
  • Selenium, Scandium, Silicon, Strontium, Sulfur, Silver, Sodium, Samarium
  • Tantalum, Tellurium, Thallium, Tin, Titanium, Tungsten, Thulium, Thorium, Terbium
  • Uranium
  • Vanadium
  • Ytterbium, Yttrium
  • Zinc, Zirconium
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Medical Device Testing

Price on request

Compliance with international standards for medical devices can be complex, from understanding contaminants to suitability for use, a trusted testing partner is key. Choosing your outsourcing partner involves many factors, from experience to leading edge technology, Impact Analytical leads the field.

With the combination of... Show more »

Compliance with international standards for medical devices can be complex, from understanding contaminants to suitability for use, a trusted testing partner is key. Choosing your outsourcing partner involves many factors, from experience to leading edge technology, Impact Analytical leads the field.

With the combination of experienced analytical scientists and a rigorous quality program, Impact Analytical has become a major supplier of analytical services to the medical device industry. We are meticulous and detailed. We base our approach on your needs; utilizing a consultative approach to identify solutions. Our scientists have expertise analyzing a wide range of sample types, including plastics, raw materials, chemicals, contaminants and gases. Impact Analytical’s quality program includes a full-time quality manager, an experienced audit team and an experienced quality assurance unit (QAU). Whether you need full time support or extra capacity during peak workloads, Impact Analytical is here to support your needs.

Impact Analytical is ISO 9001:2015 certified and GLP/cGMP- compliant. With more than 20 years’ experience providing services to manufacturers.

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Headspace Gas Chromatography

Price on request

Characterization of Volatiles using Headspace GC-MS

Impact Analytical's gas separation laboratory is equipped with Headspace GC-MS analyzers – an ideal technique for characterizing volatile materials in a sample or material. Headspace GC-MS is a method of choice for residual solvents, volatile organic compounds (VOC’s), and... Show more »

Characterization of Volatiles using Headspace GC-MS

Impact Analytical's gas separation laboratory is equipped with Headspace GC-MS analyzers – an ideal technique for characterizing volatile materials in a sample or material. Headspace GC-MS is a method of choice for residual solvents, volatile organic compounds (VOC’s), and taste and odor problem solving.

Headspace GC-MS analysis services we routinely provide include:

  • Headspace GC-MS Analysis for Residual Solvents per USP <467>
  • Residuals Analysis by Headspace GC-MS
  • Headspace Analysis to Determine Off-Odors
  • Quantitation of Free Volatiles
  • Volatile Organic Compound (VOC) Testing by Headspace
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Thermal Analysis Services

Price on request
Request a quote for more information about this service.

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Failure Analysis

Price on request

Analytical testing to determine cause of failure.

Impact Analytical has 30+ years’ experience providing failure analysis services on polymeric materials in all applications. Our laboratories are equipped with the most advanced instrumentation to both characterize the mode of failure and determine its cause. Background... Show more »

Analytical testing to determine cause of failure.

Impact Analytical has 30+ years’ experience providing failure analysis services on polymeric materials in all applications. Our laboratories are equipped with the most advanced instrumentation to both characterize the mode of failure and determine its cause. Background information about a failed part’s use, materials, and its manufacture can greatly aid in determining the cause of failure as well as reduce the amount of analysis required and shorten the time required to determine a cause. Contact us today to discuss your failure analysis project.

Failure Analysis Process

When you work with us, our experts will first consult with you to discuss in detail the failure you’re experiencing. We will talk with you about the failed article’s application, service history, failure rate (is it single or multiple?) and gather information about whether the part is a new design or established part with good history. We will also discuss the material type of the failed article such as plastic type, filler type, and any known additives and recycle content. We have experience analyzing failures of many materials including:

  • CPVC piping
  • ABS
  • Polyolefins (HDPE, polypropylene, etc.)
  • Chrome-plated plastics
  • Painted materials
  • Polycarbonate
  • Nylon
  • Polyesters
  • Rubbers
  • TPO

After we have discussed your failed material we’ll provide you with a detailed quote and testing plan for your failure analysis project that’s specific to your failed article/product. To get started, please Request a Quote.

Failure Analysis Techniques

The combination of our experienced analysts and instrumentation allow our failure analysis and testing services to solve your material failure and help you prevent it from happening again. No two failure analysis projects are the same but instrumentation that is often used includes:

  • Optical Microscopy - will examine the failure surface to look for patterns in break and/or surface wear that will give clues to the mechanism and provide an overall sense of the failure.
  • Scanning Electron Microscopy (SEM) - will provide detailed images of failed, fractured or cracked surface. It also uncovers clues of the failure such as identifying the point of origin, determining the propagation direction and the mechanical properties.
  • Fourier Transform Infrared Spectroscopy (FT-IR) - will identify and/or confirm material type to ensure the proper material was used. It will also identify if any contaminants are present.

Failure Analysis Goals

The goal with every failure analysis project is to characterize the morphology of the failure, determine the most likely cause, and finally advise you on how to eliminate the failure from reoccurring. Some common examples of failure modes include:

  • Poor product design
  • Poor molding
  • Incorrect choice of material for desired application
  • Material contamination
  • Overstress of material
  • Change in material supply
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Coating Analysis

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Characterization of coatings on surfaces and materials

Coatings are crucial components to finished products, materials, pharmaceuticals, and polymers. Impact Analytical has performed numerous coating testing and analysis projects for various industries and needs.

Services we can provide involving coating materials... Show more »

Characterization of coatings on surfaces and materials

Coatings are crucial components to finished products, materials, pharmaceuticals, and polymers. Impact Analytical has performed numerous coating testing and analysis projects for various industries and needs.

Services we can provide involving coating materials include:

  • Coating Deformulation
  • Coating identification by Fourier Transform Infrared Spectroscopy (FT-IR)
  • Characterization for coating thickness
  • VOC Testing of coating materials
  • Evaluation of surface coatings for contaminants
  • Failure analysis of coating materials
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Package and Container Testing

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Antioxidant Assays

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Identification and quantitation of antioxidants in polymeric materials

Impact Analytical has more than 20 years of experience providing analytical analyses for antioxidants. Our laboratories are equipped with the most advanced instrumentation to perform your analysis.

Antioxidant components are added to polymers to absorb... Show more »

Identification and quantitation of antioxidants in polymeric materials

Impact Analytical has more than 20 years of experience providing analytical analyses for antioxidants. Our laboratories are equipped with the most advanced instrumentation to perform your analysis.

Antioxidant components are added to polymers to absorb oxidation and to shield the polymer material from degradation. Antioxidant packages can vary depending on the manufacturer, molder, application, or identity of the polymer material. Degradation can be caused by weathering and can lead to brittleness and yellowing of the product. As a result, being able to quantitate antioxidants and corresponding oxidation products in a polymer will provide information on the rate of degration for the antioxidant. Common antioxidants include, but are not limited to:

  • Irganox 1010
  • Irganox 1076
  • Irgafos 168
  • Butylated hydroxytoluene (BHT)

The identification of an additive package may also be required for reverse engineering or deformulation of a competitor’s product.

The Impact Analytical work process

When you work with us, our experts will first consult with you to discuss the objectives for the project and gather any available information about the product. Background information about the product can greatly aid in the identification of antioxidants as well as reduce the time required for the project. Our experts will work you and will work internally to develop the most efficient analysis plan and to select the most appropriate techniques for the project.

Techniques used for the process

Most antioxidant analyses will require some separation of components within the sample. Impact Analytical has the most advanced instrumentation to perform additive analyses after achieving some separation of components. Impact Analytical routinely analyzes for antioxidants using LC-MS, GC-MS, and HPLC-UV instruments. Our LC-MS can provide accurate mass information on components in the sample, which leads to timely identification of the antioxidants in the product. The LC-MS can also detect compounds without UV chromophores that would not be detected by HPLC-UV. GC-MS can detect more volatile components in the additive package. HPLC-UV may be used for quantitation of compounds in the additive package that have good UV chromophores. Only the most appropriated techniques will be used for the project helping you to manage the cost of the project.

Final product

Impact Analytical will communicate with you during your antioxidant analysis to ensure that your project objectives are met. Throughout the project you will be able to determine whether or not your needs have been satisfied and to determine if additional testing is required to satisfy your needs. A quality analysis for antioxidants will be the end product of our testing.

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Drug Release Studies/In Vitro Release Testing (IVRT)

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Release testing is an important aspect of the pharmaceutical drug development and product process. It is critical that this testing be performed accurately, compliantly and quickly. Impact Analytical has a full breadth of analytical offerings to meet any release testing need. Our scientists understand the time sensitivity around... Show more »

Release testing is an important aspect of the pharmaceutical drug development and product process. It is critical that this testing be performed accurately, compliantly and quickly. Impact Analytical has a full breadth of analytical offerings to meet any release testing need. Our scientists understand the time sensitivity around developing methods for new drug products to efficiently and safely take them to market.

Whether release testing encompasses an assay of an active ingredient and evaluation of impurities of a drug product, characterization of a medical device for compliance, or analysis of a manufactured product to confirm specification and acceptance, we have the experience to meet your testing needs.
Finally, our robust quality system will stand watch over the entire process to make certain all data provided is compliant with the appropriate regulations. Impact Analytical offers release testing in the following laboratories:

  • Liquid separations – HPLC, UPLC, LC-MS, Karl Fisher, SEC/GPC
  • Gas separations – GC-FID, GC-TCD, GC-MS, Headspace GC, SPME
  • Molecular characterization – FT-IR, NMR, UV/Vis
  • Thermal analysis – DSC, TGA
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Regulatory Affairs Services

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Physical Analysis Methods

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Wet Chemical Analysis

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Spectrophotometry

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Validation, Services

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UV-VIS Spectroscopy

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Trace Metal Analysis

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Elemental and Trace Metals Analysis

Inductively Coupled Plasma – Optical Emission Spectroscopy (commonly known as ICP-OES), and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) are two popular techniques used in trace and ultra-trace elemental analysis. ICP-OES analysis is an excellent technique for identifying and... Show more »

Elemental and Trace Metals Analysis

Inductively Coupled Plasma – Optical Emission Spectroscopy (commonly known as ICP-OES), and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) are two popular techniques used in trace and ultra-trace elemental analysis. ICP-OES analysis is an excellent technique for identifying and quantifying elemental constituents in various sample matrices including polymers, pharmaceuticals, chemicals, solutions, plastics, metals, and consumer products. ICP-MS analysis provides ultra-trace elemental analysis to identify and quantitate elements down to the sub parts-per-billion range, while utilizing a dynamic collision cell to eliminate troublesome interferences.

With ICP-MS and ICP-OES capabilities, we can identify and quantify trace metals at percentage levels, as well as parts per million (ppm), parts per billion (ppb), and parts per trillion (ppt) levels by using established sample preparation techniques and analyses. Varying digestion techniques, including aqua regia, HF, as well as the use of hot plate digestion and microwave digestion for hard-to-digest materials allows our lab to get nearly any product into a solution where they can be analyzed for metals.

Impact Analytical quality program is certified to the ISO 9001:2008 system standard. Don’t have a method to use? Our experienced staff can perform method development and method validation to meet your specific needs. Our cGMP and GLP -compliant facility can administer elemental testing by ICP-OES and ICP-MS in compliance with ICH Q3D and USP Chapters <232> and <233>.

Examples of ICP analysis services provided by Impact Analytical:

  • Single or multi-element analysis
  • Heavy metals analysis
  • Impurity testing
  • Package testing for support of Extractables & Leachables studies
  • USP 232 and 233 testing
  • Analysis of Wax and Fragrance Samples
  • Lead content
  • Molecular Sieve analysis
  • Beauty and cosmetics samples
  • Medical devices
  • Identify unknowns
  • Many others (ask to see if we can perform your unique testing)

We can detect and measure the following trace and ultra-trace metals:

  • Aluminum, Antimony, Arsenic
  • Barium, Beryllium, Bismuth, Boron
  • Cadmium, Calcium, Chromium, Cobalt, Copper, Cerium, Cesium
  • Dysprosium
  • Europium, Erbium
  • Iron
  • Germanium, Gold, Gallium, Gadolinium
  • Hafnium, Holmium
  • Indium, Iridium
  • Lead, Lithium, Lanthanum, Lutetium
  • Magnesium, Manganese, Mercury, Molybdenum
  • Nickel, Neodymium, Niobium
  • Osmium
  • Palladium, Phosphorus, Platinum, Potassium, Praseodymium
  • Rhodium, Ruthenium, Rhenium, Rubidium
  • Selenium, Scandium, Silicon, Strontium, Sulfur, Silver, Sodium, Samarium
  • Tantalum, Tellurium, Thallium, Tin, Titanium, Tungsten, Thulium, Thorium, Terbium
  • Uranium
  • Vanadium
  • Ytterbium, Yttrium
  • Zinc, Zirconium
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GC-MS

Gas Chromatography Coupled Mass Spectrometry
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Thermogravimetric Analysis (TGA)

Thermogravimetric Analysis
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Chemical Stability Testing

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Product Stability Testing

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Chiral Resolution

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Raw Material Testing

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Raw material characterization plays an important part in the quality control process of product manufacture or development, ensuring that contaminants, residual solvents, catalysts, water, particles, and/or degradants meet specifications.

Impact Analytical has a full suite of analytical capabilities to characterize all... Show more »

Raw material characterization plays an important part in the quality control process of product manufacture or development, ensuring that contaminants, residual solvents, catalysts, water, particles, and/or degradants meet specifications.

Impact Analytical has a full suite of analytical capabilities to characterize all classes of raw materials. We have the experience to develop & validate new methods for characterization. We can transfer these methods to the client, or if needed, provide raw material support on a routine basis.

When you work with us, our experts will first consult with you to determine your specific needs. Discussions will include types of chemical analyses required, sample amounts, sample solubility, sample handling restrictions, and level of reporting required. The level of reporting can be an informal one-page document, or more formal reports including certificates of analysis, such as our standard ISO report, GLP/cGMP report for Federal agency (FDA and EPA) requirements in the United States, or REACH report for European Union requirements.

Examples of raw materials we have experience characterizing include:

  • Drug Product Excipients
  • Solvent Purity
  • Monomers
  • Drug Substance Intermediates
  • Salts
  • Catalyst Materials
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R&D Services

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Testing support for product research and development

Impact Analytical provides analytical testing to support drug product and medical device research and development. Impact’s scientists have a combined 300+ years of experience in analytical chemistry. We have experience developing material specific assays and methods for... Show more »

Testing support for product research and development

Impact Analytical provides analytical testing to support drug product and medical device research and development. Impact’s scientists have a combined 300+ years of experience in analytical chemistry. We have experience developing material specific assays and methods for use in research support that can subsequently be utilized for final product testing. Our dedicated R&D support teams partner directly with the client to provide chemical and material testing support that ensures timeline integrity. This approach allows the client to access our experience and regulatory knowledge directly, saving time and budget.

Impact Analytical provides focused support for API development, assay and impurities methods development, container closure material selection, stability, drug or material compatibility, dissolution, extractables, accelerated stability, and medical device material selection. This support can be leveraged from development through preclinical, phases I and II, and final product manufacture.

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Quality Assurance

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Contract Services Directory

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Process Consulting

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Photostability Studies

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Particle Analysis and Characterization

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Nonclinical Research

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Microscopic Analysis

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Micro FT-IR Analysis

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Material Testing Services

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Mass Spectrometry

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Batch Release Testing

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HPLC

High Performance Liquid Chromatography
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GMP Auditing

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GLP Auditing

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Forced Degradation Studies

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Feasibility Studies

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Extractable and Leachable Testing

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The materials used to fabricate container closure systems (CCS), medical devices, and processing equipment are often polymers, such as plastic or elastomers (rubber), rather than metal or glass. Polymers offer more versatility, since they are light-weight, flexible and much more durable than their traditional counterparts.... Show more »

The materials used to fabricate container closure systems (CCS), medical devices, and processing equipment are often polymers, such as plastic or elastomers (rubber), rather than metal or glass. Polymers offer more versatility, since they are light-weight, flexible and much more durable than their traditional counterparts. Additives can be incorporated into polymers to give them clarity that rivals that of glass, or to add color to the materials, or that can give the polymer a desired physical property. However, given all of the positive attributes that polymers possess, there are also some negatives to consider when working with them in medical applications. In the presence of heat, light, oxygen and various external influences, such as sterilization, polymers can degrade over time if not properly stabilized. This degradation can manifest itself as cracking, discoloration, or surface blooming/exudation and can severely impact the mechanical properties of the polymers. Stabilizers, and other additives, are often incorporated into polymers to prevent this degradation. Yet this results in a more complex formulation than typical metal and glass, and makes materials such as plastic and rubber much more prone to leaching unwanted chemicals into the drug product formulation when they are used in applications such as manufacturing, drug delivery devices, or packaging. The experts at Impact Analytical have the experience and resources to perform Extractables and Leachables studies that mitigate the risk associated with using these materials and ensure a safe and compliant product.

Our extensive plastics characterization experience is the backbone of our Extractables & Leachables testing regiment. This knowledge serves as a solid foundation for our experts to quickly and efficiently characterize container closure systems for leachables. We follow Product Quality Research Institute (PQRI) best practices to ensure all studies are thorough and compliant. While a proven testing process is the starting point, each project benefits from our scientific experience and ability to customize methods and develop the best testing solutions.

Extractables & Leachables Process

1.Evaluate
– Initial materials assessment
– Primary contacting components
– Secondary contacting components
– Associated closure and packaging systems
> Associated components

2.Controlled Extraction Studies
– Material extraction
– Analysis of the extracts
> Multiple separation and detection techniques to identify volatiles, semi-volatiles, non-volatiles and inorganics
> Establishment of leachables threshold limits

3.Leachables Method Development and Validation
– Leachables testing
– Correlation establishment
– Evaluation of leachable profile
> Toxicology evaluation

4.Ongoing Testing
– Release testing
– Lot Testing

Impact Analytical is a cGMP compliant laboratory that has been recently audited by the FDA, with no 483’s issued. All study design and E&L testing is performed according to the latest industry recognized “best practices” including the United States Pharmacopeia (USP), Product Quality Research Institute (PQRI), Bio-Process Systems Alliance (BPSA), and ISO-10993.

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Size Exclusion Chromatography (SEC)

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Expert Testimony

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Drug Discovery

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Solubility and Dissolution Testing

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Imaging & Spectroscopy

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Contract Research

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Ionization/Fragmentation Methods

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Ionization/Fragmentation Methods Services

Ionization/Fragmentation Methods Services

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Chemical Contaminant Analysis

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Auditing and Compliance Support

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Consulting

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Gas Chromatography (GC)

Gas Chromatography
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Gas Chromatography (“GC”) is an analytical technique used for separating liquids or gases via a capillary column using gas as the solvent medium.

This technique is used to characterize, identify, and quantitate volatile and semi-volatile components in various sample matrices. Contaminants can be determined from the percent... Show more »

Gas Chromatography (“GC”) is an analytical technique used for separating liquids or gases via a capillary column using gas as the solvent medium.

This technique is used to characterize, identify, and quantitate volatile and semi-volatile components in various sample matrices. Contaminants can be determined from the percent level to part per billion (“PPB”) depending on the analyte being detected.

While the GC is a temperature controlled oven, it is the detector to which it is coupled that determines what can be seen. At Impact Analytical our scientists can use detectors such as:

  • Flame Ionization Detection (FID)
  • Thermal Conductivity Detection (TCD)
  • Electron Capture Ionization (ECI)
  • Mass Spectrometer (MS)
  • Taste and Odor Analysis

By utilizing both purchased (NIST) and in-house spectral databases the scientists are able to identify unknowns.

The GC’s at Impact Analytical are qualified for testing under cGMP or GLP (FDA, EPA) guidelines.

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Chemical Analysis

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Product Testing Services

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Product Testing Services

Product Testing Services

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Assay Development

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Analytical Method Validation

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Analytical Method Development

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Impact Analytical partners with our customers to develop methods that meet the customer’s validation needs. Whether you are bringing new products to market, looking for impurities in existing products, or leachable compounds in a drug product, the skills of the Impact Analytical team join forces with our customer’s experts to... Show more »

Impact Analytical partners with our customers to develop methods that meet the customer’s validation needs. Whether you are bringing new products to market, looking for impurities in existing products, or leachable compounds in a drug product, the skills of the Impact Analytical team join forces with our customer’s experts to become an extension of your own in-house team.

Count on Impact Analytical to provide extensive assistance in the development and validation of analytical methods.

Analytical Method Development and Validation

It is critical in the development of new methods that the analytes of interest be clearly identifiable prior to performing a validation study. The new methodology must be capable of not only observing the analytes in question, but that they are quantifiable, and not obstructed by other components in the matrix. The Study Directors at Impact Analytical work with our customersto determine the best technique for analysis (given a full understanding of the manufacturing process, the matrix, and what could potentially be present). Our extensive knowledge in this field helps us to design a testing protocol that will be scientifically defensible when our clients submit their product for approval to the regulatory agencies. The laboratory will develop methods capable of detecting these analytes using the most appropriate sample preparation and analysis techniques. When a suitable method has been defined, a protocol will be provided and the method evaluated in compliance with ICH guidelines.

Each new method developed by Impact Analytical on behalf of our customers will assess the following:

  • Linearity
  • Precision (repeatability and intermediate precision)
  • Accuracy
  • Specificity
  • Limit of detection
  • Limit of quantification
  • Range
  • Robustness and stability of test solutions
  • Advanced analytical techniques and state-of–the-art equipment are employed to perform the analysis required:
  • Gas chromatography (GC)
  • Gas chromatography/mass spectroscopy (GC/MS)
  • High-performance liquid chromatography (HPLC)
  • High-performance liquid chromatography/mass spectroscopy (HPLC/MS)
  • Inductively coupled plasma (ICP) spectroscopy
  • Ultraviolet/visible (UV/VIS) spectroscopy
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Product Quality Control

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Routine testing of incoming raw materials, process chemicals or process intermediates to meet material specifications.

Quality control of process materials is critical to the success of any manufacturing facility. Ensuring materials are of consistent quality is vital to producing a final product that meets customer... Show more »

Routine testing of incoming raw materials, process chemicals or process intermediates to meet material specifications.

Quality control of process materials is critical to the success of any manufacturing facility. Ensuring materials are of consistent quality is vital to producing a final product that meets customer expectations. Impact Analytical has the technologies, methods and processes in place to deliver the full spectrum of quality control testing needs, including:

  • QC method development
  • QC method validation
  • QC method transfer
  • Temporary QC testing support
  • Full QC testing support transfer
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Analytical Chemistry Services

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Atomic Emission Spectroscopy

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Atomic Emission Spectroscopy Services

Atomic Emission Spectroscopy Services

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Other Mass Spectrometry Methods

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Other Mass Spectrometry Methods Services

Other Mass Spectrometry Methods Services

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Biology

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Medical Devices & Diagnostics

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Medical Devices & Diagnostics Services

Medical Devices & Diagnostics Services

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Environmental Science

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Strength Analysis

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Cells and Tissues

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Formulation Services

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Product Development, Testing, and Packaging

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Pharmacology & Toxicology

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Chromatography

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Packaging Services

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Spectroscopy

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Liquid Chromatography (LC)

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Microscopy

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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Separation/Purification Services

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Drug Discovery & Development

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Specialized Cell-Based Assays

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In vitro Disease Models

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Clinical Research

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Clinical Laboratory Services

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Business Development Consulting

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Project Management

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Chemistry and Materials

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Water Quality Monitoring

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Sessile Drop Contact Angle Measurement

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pH Measurement

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NMR

Nuclear magnetic resonance spectroscopy
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Mass Spectrometry Data Analysis

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