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Excite Pharma Services

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Lee’s Summit, Missouri, US

About Excite Pharma Services

Excite Pharma Services was founded in 2009, focusing mainly on energy and environmental testing services. In December 2012, the company saw a need in the pharmaceutical industry for a high-quality provider of CMC (Chemistry, Manufacturing & Controls) services and began to sell their capabilities to pharma... Show more »

Excite Pharma Services was founded in 2009, focusing mainly on energy and environmental testing services. In December 2012, the company saw a need in the pharmaceutical industry for a high-quality provider of CMC (Chemistry, Manufacturing & Controls) services and began to sell their capabilities to pharma companies in the North America region. Built on the values of quality, timing and price, the company has grown steadily over the past 4 years as pharmaceutical companies have responded positively to our expertise and quality contract service work in the CMC space.
Excite Pharma Services is an FDA-inspected, cGMP contract research / manufacturing organization with specialized focus on analytical chemistry covering drug substance, drug product, APIs and excipients.

In February 2016, the company opened a cGMP sterile fill / manufacturing facility in its Lee’s Summit, Missouri headquarters. The facility features an ISO 5 certified cleanroom and is focused for injectable product filling / manufacturing though other products can be manufactured under special circumstances.

Services include:
- Method Development, Validation & Transfer
- Stability Programs
- Release Testing
- Dissolution
- Residual Solvent Analysis
- Extractables & Leachables
- Elemental Impurities & Metals Analysis
- cGMP Manufacturing & Sterile Fill (ISO 5 - 8 Clean Rooms)
- Microbial & Visual Inspections
- Packaging & Labeling
- Storage & Distribution

Today, Excite Pharma Services takes great pride in serving its customers. Quality is critically important to us, as we know the successful development of your drug depends on it.

Publications

  • A Simple Procedure for the Rapid Determination of the Bulk Constituents of Certain Insulation Materials, Keith K. Koehler and Peter F. Lott, Microchemical Journal, 57, 328-331 (1997).
  • A study in the determination of phenyl-2-propanone from an illicit laboratory operation, Keith K. Koehler, Rekha Patel, Revathy Venkatachalam, John J. Whitchurch, and Peter F. Lott, Microchemical Journal, 53, 236-240 (1996).
  • Color-forming reactions of benzenoid hydrocarbons and related polycyclics with concentrated sulfuric acid, Jerry Ray Dias and Keith K. Koehler, Polycyclic Aromatic Compounds, Vol. 5, 1994, pp. 79-86.
  • The separation of fexodenadine, pseudoephedrine and potential impurities and degradation products using ion interaction chromatography, Gary L. Schmitt and Thomas A. Walker, J. Liq. Chromatogr. and Rel. Tech., 29, 2006, 25 – 43.
  • Bupropion hydrochloride: the development of a chiral separation using an a1-acid glycoprotein column, James Munro, J. Peter Gormley and Thomas A. Walker, J. Liq. Chromatogr. and Rel. Tech., 24(3), 2001, pp. 327-339.
  • Bupropion hydrochloride: the development of a chiral separation using an ovomucoid column, James S. Munro and Thomas A. Walker, J. Chromatogr. A, 913, 2001, 275-282.
  • Ranitidine hydrochloride: the development of an isocratic stability-indicating high performance liquid chromatographic separation, Thomas A. Walker, J. Chromatogr. A, 914, 2001, pp. 13-21.
    The chiral separation of oxybutynin enantiomers using an ovomucoid column, Thomas A. Walker, J. Liq. Chromatogr. and Rel. Tech., 23(6), 2000, pp. 841-853.
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Certifications & Qualifications

ISO 17025

Our Services (16)


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ICH Stability Testing

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Elemental Analysis

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Excite Pharma Services routinely performs contract services according to the USP 232 (Elemental Impurities Limits), USP 233 (Elemental Impurities Procedures) and USP2232 (Elemental Contaminants in Dietary Supplements) and ICH Q3D metals testing guidelines; analyzing elemental impurities in drug substances (APIs), drug products and... Show more »

Excite Pharma Services routinely performs contract services according to the USP 232 (Elemental Impurities Limits), USP 233 (Elemental Impurities Procedures) and USP2232 (Elemental Contaminants in Dietary Supplements) and ICH Q3D metals testing guidelines; analyzing elemental impurities in drug substances (APIs), drug products and excipients. The USP and ICH have harmonized their guidance.

Elemental impurities are defined as catalysts and environmental contaminants which may occur naturally, added intentionally or introduced inadvertently. Because such impurities do not provide any therapeutic benefit to the patient, their levels in drug product should be controlled within acceptable limits. The guidelines mentioned above are meant to present a process to assess and control elemental impurities in drug products, substances and excipients.
The USP/ICH have designated three classes of elements, based on their toxicity and likelihood of occurrence in the drug product. The toxicity of an elemental impurity is related to its extent of exposure (bioavailability).

Class 1 elements are known human toxicants that have limited or no use in the manufacture of pharmaceuticals. Their presence in drugs products typically comes from commonly used materials (ex. mined excipients). Because of their inherent risks, these four elements MUST be tested under all circumstances. Impurities listed in Class 1 are As, Cd, Hg and Pb.
Class 2A elements have relatively high probability of occurrence in the drug product and thus require risk assessment across all potential sources of elemental impurities and routes of administration. Impurities listed in Class 2A are Co, Ni and V.
Class 2B elements have a reduced probability of occurrence in the drug product related to their low abundance and low potential to be co-isolated with other materials. As a result, they may be excluded from the risk assessment unless they are intentionally added during the manufacture of drug substances, excipients or other components of the drug product. Impurities listed in Class 2B are Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se and TI.
Class 3 elements have relatively low toxicities by the oral route of administration, but may require consideration in the risk assessment for inhalation and parenteral routes. Unless these elements are intentionally added, they do not need to be considered during the risk assessment for oral routes of administration. For parenteral and inhalation products, the potential for inclusion of these elemental impurities should be evaluated during the risk assessment, unless the route specific PDE is > 500µg/day. Impurities listed in Class 3 are Ba, Cr, Cu, Li, Mo, Sb and Sn.

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Chemical Stability Testing

Price on request

Excite Pharma Services offers stability programs for drug substances (APIs) and drug products and utilizes the ICH Guideline (Q1E) for the design of its stability studies. We offer normal and accelerated environments per the guidance, as well as refrigerated, frozen and photostability conditions if necessary.

The purpose of... Show more »

Excite Pharma Services offers stability programs for drug substances (APIs) and drug products and utilizes the ICH Guideline (Q1E) for the design of its stability studies. We offer normal and accelerated environments per the guidance, as well as refrigerated, frozen and photostability conditions if necessary.

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions. Stability testing is essential to establish the proper packaging configuration for finished drug products. (ex. clear vs. amber vials, foil pouches, blister packs, etc)

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Analytical Method Development

Price on request

Excite Pharma Services offers method development, validation and transfer services for drug substances (APIs), drug products, related substances, impurities and biological matrices to supplement IND and NDA submissions. We utilize both the US Pharmacopeial Convention’s “Validation of Compendial Procedures” guideline (USP 1225)... Show more »

Excite Pharma Services offers method development, validation and transfer services for drug substances (APIs), drug products, related substances, impurities and biological matrices to supplement IND and NDA submissions. We utilize both the US Pharmacopeial Convention’s “Validation of Compendial Procedures” guideline (USP 1225) and the ICH Q2 (R1) Methodology for Analytical Validation. For bioanalytical method validations, we employ the FDA’s Bioanalytical Method Validation Guidance for Industry.

Excite Pharma Services recognizes that depending on your stage of development, full method validation may not be required. We do offer abbreviated services for method verification when full validation is unnecessary. We also recognize that clients may have varying degrees of development already completed which is always taken under close advisement when evaluating a project and the associated costs.

Excite Pharma Services’ staff have developed and validated hundreds of analytical methods. They have also transferred methods to clients around the world.

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Extractable and Leachable Testing

Price on request

Extractables & leachables testing and analysis is a critical step in maintaining the quality of your drug product. Excite Pharma Services provides expert guidance and contract research services to ensure your successful drug development.

Extractables studies are assessments performed on materials. They are performed to... Show more »

Extractables & leachables testing and analysis is a critical step in maintaining the quality of your drug product. Excite Pharma Services provides expert guidance and contract research services to ensure your successful drug development.

Extractables studies are assessments performed on materials. They are performed to identify substances that a patient may be exposed to.

Leachables studies are an assessment performed on the drug product. Materials that come into direct or indirect contact with a drug or biologic product have the potential to leach substances into the final pharmaceutical product. Substances that may leach can originate from various materials at any point in the pharmaceutical supply chain and throughout the product lifecycle. Constituents that leach from primary packaging into the final product when manufactured and stored under its normal conditions are referred to as leachables. Typically, leachable compounds are found in trace amounts but can have a negative impact on pharmaceutical quality with potential to compromise patient safety. Any component used during drug or biologic manufacture, storage, shipping and administration to the patient can be implicated as a source of extractables and leachables.

Excite Pharma Services utilizes the following analytical techniques for extractables & leachables services:

  • ICP-MS, GC-MS, PDA / UV Vis, pH, Ion Chromatography, GC-ECD, multiple extraction techniques
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Impurity Analysis

Price on request

Excite Pharma Services routinely performs contract services according to the USP 232 (Elemental Impurities Limits), USP 233 (Elemental Impurities Procedures) and USP2232 (Elemental Contaminants in Dietary Supplements) and ICH Q3D metals testing guidelines; analyzing elemental impurities in drug substances (APIs), drug products and... Show more »

Excite Pharma Services routinely performs contract services according to the USP 232 (Elemental Impurities Limits), USP 233 (Elemental Impurities Procedures) and USP2232 (Elemental Contaminants in Dietary Supplements) and ICH Q3D metals testing guidelines; analyzing elemental impurities in drug substances (APIs), drug products and excipients. The USP and ICH have harmonized their guidance.

Elemental impurities are defined as catalysts and environmental contaminants which may occur naturally, added intentionally or introduced inadvertently. Because such impurities do not provide any therapeutic benefit to the patient, their levels in drug product should be controlled within acceptable limits. The guidelines mentioned above are meant to present a process to assess and control elemental impurities in drug products, substances and excipients.
The USP/ICH have designated three classes of elements, based on their toxicity and likelihood of occurrence in the drug product. The toxicity of an elemental impurity is related to its extent of exposure (bioavailability).

  • Class 1 elements are known human toxicants that have limited or no use in the manufacture of pharmaceuticals. Their presence in drugs products typically comes from commonly used materials (ex. mined excipients). Because of their inherent risks, these four elements MUST be tested under all circumstances. Impurities listed in Class 1 are As, Cd, Hg and Pb.
  • Class 2A elements have relatively high probability of occurrence in the drug product and thus require risk assessment across all potential sources of elemental impurities and routes of administration. Impurities listed in Class 2A are Co, Ni and V.
  • Class 2B elements have a reduced probability of occurrence in the drug product related to their low abundance and low potential to be co-isolated with other materials. As a result, they may be excluded from the risk assessment unless they are intentionally added during the manufacture of drug substances, excipients or other components of the drug product. Impurities listed in Class 2B are Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se and TI.
  • Class 3 elements have relatively low toxicities by the oral route of administration, but may require consideration in the risk assessment for inhalation and parenteral routes. Unless these elements are intentionally added, they do not need to be considered during the risk assessment for oral routes of administration. For parenteral and inhalation products, the potential for inclusion of these elemental impurities should be evaluated during the risk assessment, unless the route specific PDE is > 500µg/day. Impurities listed in Class 3 are Ba, Cr, Cu, Li, Mo, Sb and Sn.
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Residual Solvent Analysis

Price on request

Excite Pharma Services offers residual solvent analysis programs for drug substances (APIs), drug products and excipients utilizing the U.S. Pharmacopeial Convention guideline (USP 467) for the design of its residual solvent studies. Individual customized programs are available.

Residual solvents are organic volatile impurities... Show more »

Excite Pharma Services offers residual solvent analysis programs for drug substances (APIs), drug products and excipients utilizing the U.S. Pharmacopeial Convention guideline (USP 467) for the design of its residual solvent studies. Individual customized programs are available.

Residual solvents are organic volatile impurities (OVIs) either used or produced during the manufacture of APIs (Active Pharmaceutical Ingredients), excipients and / or drug products. Residual solvent analysis is used to ensure pharmaceuticals are free from toxicologically significant levels of volatile organic compounds either left behind or created in the manufacturing process.

Residual solvent analysis is a very important QC procedure in the pharma industry. Sampling is typically performed by static headspace and analysis is done by GC/FID (flame ionization detector) using a dedicated column. GC/MS (mass spec) can also be used for residual solvent analysis.

There are 3 classes of solvents: Class 1, 2 and 3. Class 3 solvents have a low toxic potential to humans. No long-term toxicity or carcinogenicity data are available for many of these substances. Class 2 solvents are non-genotoxic animal carcinogens. Solvents in this class should be limited in pharmaceutical products because of their inherent toxicity. Class 1 solvents (carcinogens) are strongly suspected of being both harmful to humans and environmental hazards. If possible, they should be avoided or at the least have their levels controlled.
Testing of drug substances, excipients, and drug products for residual solvents should be performed when production or purification processes are known to result in the presence of such residual solvents. It is only necessary to test for residual solvents that are used or produced in the manufacture or purification processes.

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Solubility and Dissolution Testing

Price on request

Excite Pharma Services offers dissolution testing for drug products and utilizes the USP Guidance (USP 711) for the design of its dissolution studies. Excite Pharma Services offers both the basket and paddle dissolution apparatuses as outlined in the USP guidance.

The purpose of dissolution testing is to provide critical in... Show more »

Excite Pharma Services offers dissolution testing for drug products and utilizes the USP Guidance (USP 711) for the design of its dissolution studies. Excite Pharma Services offers both the basket and paddle dissolution apparatuses as outlined in the USP guidance.

The purpose of dissolution testing is to provide critical in vitro drug release information for both quality control purposes (batch-to-batch consistency of solid oral dosage forms like tablets) and drug development purposes (to predict in vivo drug release profiles).

The rate at which the active ingredient is released is called the dissolution rate and is important to ensure the drug is delivered properly.

Dissolution testing is required for all dosage forms administered orally.

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Assay Development

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Project Management

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Chemistry and Materials

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Formulation Services

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Product Testing Services

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Product Testing Services

Product Testing Services

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Product Development, Testing, and Packaging

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Analytical Chemistry Services

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Product Quality Control

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