Quantum Analytics provides analytical testing services to the pharmaceutical, biotechnology, medical device, personal care products, cosmetics and other life science industries. We provide a comprehensive range of capabilities, from the testing of a single sample to large projects or programs. We are known for responsiveness to customer needs, flexibility in our approach, and essential project communication from scientist to scientist -serving as An Extension of Your Team. These comprehensive services include method development, method validation, impurities identification and characterization, contaminant identification, residual solvents, QC testing, release testing, raw materials testing, compendial testing, extractables and leachables, stability and shelf life studies.
We are FDA registered and inspected, and cGMP and GLP compliant. The data generated by our laboratories on behalf of customers are included with regulatory submissions in support of approvals by FDA and international regulatory agencies as well as sustaining existing products in the market.
In addition, we perform cGMP compliant routine-testing and/or undertake GLP compliant studies using a variety of analytical techniques including GC, HPLC, IC, LC/MS, GC/MS, AAS, ICP, ICP-MS, FT-IR and UV-Vis. We are also capable of combining these techniques to provide novel approaches to product release testing, extractables/leachables testing and package suitability studies.
Quantex Laboratories provides comprehensive analytical method development and method validation services. Our knowledgeable and experienced scientists develop methods using a wide range of analytical techniques. Analytical methods developed include procedures for active pharmaceutical ingredients (APIs), drug formulations, cosmetics, personal care producuts, and raw materials.
Method validation is designed collaboratively, based upon your specific requirements. Protocols employed can be customer supplied or written by Quantex's technical staff using our method validation templates. In the development and validation of stability indication methods, we can perform forced degradation studies on your drug substance or product to provide stability validation of the analytical procedures. Routine forced degradation is also carried out using acid, base, peroxide, heat, and light.
Quantex Laboratories supports your product Quality Control and Release Testing needs for Active Ingredients intermediates, excipients and finished products. We have experience testing for many types of formulations. Our QC Release Testing group help you ensure that your products are safe and efficacious from the raw material to the finished product.
Our analytical laboratories provide release testing of in-process materials as well as finished products. Whether you need results overnight or next week, we have the capabilities to meet your most demanding turnaround time requirements.
Quantex Laboratories performs comprehensive analytical testing of raw materials, active pharmaceutical ingredients, excipients and finished pharmaceutical products. Our services can assist you in the qualification of your vendors or in the release of raw materials for production and manufacturing purposes. Compendial testing is performed in accordance with USP/NF, BP, EP, JP, ACS and FCC methodologies and monographs, as well as with client-supplied or vendor-specified methods.
Quantex’s highly trained scientists, in conjunction with our considerable investment in laboratory resources, can handle the analysis of significant quantities of samples. We maintain well equipped state-of-the-art laboratories that routinely support the analysis of raw materials including actives, fillers, binders, colors, and other excipients. All our laboratory operations and procedures are based on written, detailed SOPs and stringent quality assurance practices in compliance with cGMP regulations.
Quantex Laboratories offers a complete range of stability testing services to assist you with your stability testing requirements. We can handle your complete stability study needs - from providing the appropriate storage for your samples, to pulling samples at specified intervals , to testing them according to the specified procedures and time table you require. Or, if you prefer, we can analyze samples that you store and send to us at specified testing intervals. All stability studies are carried out in compliance with FDA and ICH guidelines.
Each of our stability chambers operates independently with its own temperature and humidity controls. Temperature and humidity setpoint windows are ±2OC and ±5% RH, respectively. All storage chambers are continuously monitored by 21 CFR part 11 compliant computerized and hardwired security systems. Chambers are also connected to automatic emergency generator power to ensure the integrity of stored samples. If a chamber should go out of specification, an alarm will notify personnel for immediate attention and corrective action.
We have numerous temperature and humidity conditions available in our qualified stability storage chambers, including all conditions needed to comply with the ICH guidelines.
Our scientists conduct extractables and leachables studies in accordance with Good Manufacturing Practices (GMPs) ,PQRI recommendations, United States Pharmacopeia (USP) requirements (including USP chapters <661>, <661.1>, <661.2>, <1663>, <1664>, and <1664.1>), recommended FDA guidelines, and recommendations of the Extractables Work Group of the BioPhorum Operations Group (BPOG) . Since a single approach to E/L studies does not fit all needs, our approach is to gain a complete understanding of our customer’s objectives, the material being used, and the potential interactions likely to occur thorough the manufacturing process. Based upon these assessments our scientists will design a custom study to assess potential sources of risk and minimize the potential for regulatory delays.
Once a profile of extractable components is obtained, we can develop validated analytical methods for those leachables, compliant with regulatory requirements and GMPs for use in storage and stability programs. These can support a wide range of closure or drug delivery systems such as pre-filled syringes, large volume parenteral products, single use and disposable medical equipment, printed packaging and single use systems (SUS) bioprocessing equipment. Leachables associated with drug delivery systems, implantable medical devices and other devices such as e-cigarettes are also assessed.
The identification and qualification of impurities and/or degradants is critical in terms of product efficacy and safety. Regulatory bodies, such as the FDA and ICH, have established clear and rigorous guidelines for setting thresholds for the reporting, identification, and qualification of impurities in drug substances and drug products.
Stress testing is an important aspect of the drug development process. Appropriate stress testing can greatly aide the elucidation of forced degradation pathways. Recent efforts by the ICH with regard to stability testing have brought increased regulatory scrutiny of impurities and the need to identify and qualify impurities at lower levels.
Controlling degradation‐related impurities involves identifying which of the potential degradation products found during stress testing actually form in either the drug substance or product under long‐term or accelerated storage conditions and then selecting the appropriate measures to minimize the impurities or degradants.
Quantex Laboratories offers comprehensive impurities testing for both small and large molecule drug products and medical devices. Our laboratories can carry out impurity profiling studies by the forced degradation of samples providing insight into potential degradion pathways and their potential impact on pharmaceutical development. Degradant related impurities can be characterized or identified by performing degradation studies under acidic, basic, oxidative, and various heat and light conditions. Degradant products can be identified by LC/MS, LC/MS/MS, GC/MS, as well as other techniques.
Quantex laboratories has extensive HPLC capabilities. Our HPLC group is well equipped with 20 state-of-the-art LC systems which include Agilent 1100 and 1200 LCs, Shimadzu LC2010 LCs, Perkin Elmer 200 series LCs and Waters Acquity UPLCs. These instruments are configured with every possible detector available for HPLC analysis – UV, DAD/PDA, FL, RI, ELSD, electrochemical –ampeometric and coulometric, CAD and MALS. Our expertise and capabilities encompass pharmaceuticals, biopharmaceuticals, medical devices, nutritional products/nutriceuticals, personal care products, cosmetics, and much more.
We are FDA registered and Inspected, ISO/IEC 17025:2005 accredited, including HPLC analyses, and both cGMP and GLP compliant.
Quantex laboratories has extensive GC capabilities. Our GC group is well equipped with 7 state of the art GC systems which include Agilent, Shimadzu and Varian (Bruker) GCs. Instruments are configured for capillary and/or packed columns, with liquid injection, headspace and purge and trap autosamplers. Detectors available include FID, TCD and ECD, as well as EI mass spec. Our expertise and capabilities encompass pharmaceuticals, biopharmaceuticals, medical devices, nutritional products/nutraceuticals, personal care products, cosmetics, and much more.
We are FDA registered and Inspected, ISO/IEC 17025:2005 accredited, including GC analyses, and both cGMP and GLP compliant.
Quantex Laboratories provides an expansive range of trace metal analytical services. Our laboratories are well equipped with state-of-the-art instrumentation which includes both flame and graphite furnace atomic absorption, inductively coupled plasma - optical emission spectrometry (ICP-OES also known as ICP-AES) and inductively coupled plasma mass spectrometry (ICP-MS). Our scientists are highly skilled in the accurate quantification of elements at trace levels and in a variety of challenging matrices, with detection limits ranging from parts per million (ppm), parts per billion (ppb) and parts per trillion (ppt).
We are experienced with a range of sample preparation techniques, including closed vessel microwave digestion techniques. Our scientists are proficient in method development and validation across a range of sample types. We can offer single or multi-element analysis services as required including multi-analyte analytical packages for heavy metals including elemental impurities testing as per ICH Q3d, and USP<232>, <233> and <2232>.
We are FDA registered and Inspected, ISO/IEC 17025:2005 accredited, including trace metal analysis, and both cGMP and GLP compliant.
Quantex laboratories has extensive GC-MS capabilities. Our GC-MS group is well equipped with 3 Agilent GC-MS systems. Instruments are configured for capillary with liquid injection, headspace and purge and trap autosamplers. Our expertise and capabilities encompass pharmaceuticals, biopharmaceuticals, medical devices, nutritional products/nutraceuticals, personal care products, cosmetics, and much more. We are FDA registered and Inspected, ISO/IEC 17025:2005 accredited, and both cGMP and GLP compliant.
Quantex laboratories has extensive LC-MS capabilities. Our LC-MS group is well equipped with 3 modern LC-MS systems from Agilent and Thermo, encompassing quadrupole, ion trap and tandem triple quad systems. Instruments are configured with either ESI or APCI, for LC and direct injection by infusion pump. Our expertise and capabilities encompass pharmaceuticals, biopharmaceuticals, medical devices, nutritional products/nutraceuticals, personal care products, cosmetics, and much more.
We are FDA registered and Inspected, ISO/IEC 17025:2005 accredited, and both cGMP and GLP compliant.
Quantex Laboratories offers clients expertise in product development under cGMP and GLP covering method development and validation for pre-formulation and formulation of products . Once our laboratories have developed and validated test methods, we provide routine QC and Monograph testing as well as stability and release testing using these validated methods. For Sponsors needing development support, Quantex can rapidly develop a variety of analytical methods using HPLC, GC, LC/MS, GC/MS, FTIR or ICP, so that the method can transferred back to the Sponsor's analytical laboratory or contract manufacturer.
As part of our QC and routine testing services Quantex provides compendial and monograph testing services. Compendial testing can be unpredictable or highly variable. Quantex has been supporting compendial testing for many years. As a result, we have dedicated resources specifically to support compendial testing for large cGMP programs, whether as the primary or alternate (secondary) analytical CRO
Organic Residual Impurities, which are commonly referred to as residual solvents, are trace level chemical residues in drug substances that are used in, or are the by-products of manufacturing. These may also form later on during the packaging process or in storage. The International Conference on Harmonization (ICH) publishes guidelines (Q3C) listing the acceptable amounts of solvent residues that are allowable to be present. Under these guidelines, residual solvents are characterized according to their toxicity by class. Class 1 compounds are carcinogenic, posing a risk to both the consumer and the environment. Class 2 compounds are nongenotoxic animal carcinogens, with concentrations of these compounds to be limited. Class 3 compounds have low toxic potential.
USP General Chapter <467> has been the generally used compendial method for identifying and quantifying residual solvents when no information is available on what solvents are likely to be present. To better mirror the ICH guidelines, on July 1, 2008, the USP implemented a new test requirement for the control of residual solvents in drug products. The new test requirement, USP General Chapter <467> Residual Solvents, replaces the previous USP General Chapter <467> Organic Volatile Impurities. This new test requirement is more comprehensive, as it increases the number of residual solvents to be routinely tested to 57. This is a much longer analyte list than previously tested and represents the sum of Class 1, 2 and 3 residual solvents. The new test requirement itself is also more extensive and divided into three distinct procedures (A, B and C) for identification, confirmation, and quantification.
The new test requirement for residual solvents under USP <467> consists of static headspace extraction followed by gas chromatographic separation and flame ionization detection (HS-GC/FID). Headspace sample preparation is also divided into two separate sections based upon sample solubility: water soluble and water insoluble articles. Procedure A is the first step in the identification process and is performed on a G43 capillary column as a means of determining if any residual solvents are present in the sample at detectable levels. Once a residual solvent is identified above the percent daily exposure limit, Procedure B is then performed to confirm analyte identity using a G16 capillary column. Once identity is confirmed, Procedure C then uses the conditions which yielded the best or most favorable separation- Procedure A or B- to provide a quantifiable result. If only Class 3 solvents are employed, their level is determined by USP method <731> Loss on Drying and if their contribution is greater than 0.5%, further testing for moisture content is required by USP method <921>
We have systems capable of performing the current USP monograph for Residual Solvents using dedicated HS-GC-FID systems. We can also perform residual solvent analysis by headspace GC/MS.
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We have used Quantum on a number of projects. Their knowledgeable staff, capabilities and experience were key to helping us. They are response, excellent in communicating progress and unexpected , in meeting project deadlines and especially keeping within budget. They are our go to lab, and we would highly recommend them.