Analytical Chemists Solving Tough Problems!
Product Testing & Development Specialists

Call us at: 1-800-930-5450

FDA & GMP Product Release Testing

Release testing, also known as lot or batch release testing is an important step in the quality control process of drug substances and drug products. This testing verifies that a pharmaceutical or bio-pharmaceutical product meets a pre-determined set of specifications. These often times include verification of the formulation’s identity, potency and purity, impurities, uniformity, identity, presentation attributes, and sterility.

Our laboratory is FDA-Registered, GLP/GMP-Compliant, ISO-17025 Accredited, and DEA-Licensed
What Products Require Release Testing to Meet GMP Compliance?

  • Raw drug substance materials & drug products that are to be used in a clinical trials
  • Raw & in-process materials used in commercial production
  • Marketed products
  • Validation batches developed for use in an ICH stability study

Avomeen’s chemists can develop, validate, and transfer even the most complex analytical methods. Our services provide an accurate analysis of time sensitive products that are under development to insure that they can be quickly approved for release and distribution into the commercial marketplace. Our laboratory can deliver a certificate of analysis for your individual product lots.

Routine Release Testing Services Include:

  • Pharmacopeia Monographs
  • Water Content Determination
  • USP Monographs
  • Chiral Purity
  • Hardness & Disintegration
  • Purity Determination (Identification & Quantification of Impurities/Related Substances)
  • pH Measurement
  • Particle Size Determination
  • Protein Purity & Concentration (Assay & Related Proteins)
  • Friability Content Uniformity
  • Impurities with Higher Molecular Masses Average Weight
  • Residual Contaminant Assays Disintegration
  • Dissolution Testing Microbial Limits Testing
  • Amperometric & Potentiometric Titration Species with Differing Charge Isomers
  • Infra-Red Spectrometry
  • UV / Visible Spectrometry
  • Out-of-Specification (OOS) Investigation
  • Conformance Testing

Physico-Chemico Properties & Other Compendial Testing Including:

  • Appearance
  • Degree of Coloration
  • Loss on Drying
  • Clarity/Opalescence pH
  • Particulates
  • Density
  • Turbidity
  • Extractable Volume
  • Osmolality & Moisture

Batch release testing for a range of products including:

  • Pharmaceuticals & Over The Counter (OTC) Products
    • Solid Dosage Forms (Tablets & Capsules)
    • Liquid Products
    • Semi-Solid Products
    • Aerosol
    • Transdermal
    • Suppositories
    • Suspensions
    • Injectables
    • Creams
    • Excipients
    • Drug Substances
  • Contact Lenses
  • Medical Devices & Implants
  • Oral Solutions
  • Biotechnology Products
    • Biosimilars
    • Protein Therapeutics
    • Monoclonal Antibodies
    • Oligonucleotides

Our chemists are flexible to your needs and timeframe, all of our projects are customized to your individual needs. We can provide rapid turnaround times on quotes and projects and maintain a high level of technical and quality assurance expertise. Our expertise in pharmaceuticals makes us the laboratory-of-choice, providing services for every stage of the drug development process.

Contact Avomeen to arrange a free initial consultation with one of our Ph.D. chemists
Call: 800-930-5450
Email: scientist@avomeen.com

Problem Solving
Avomeen scientists utilize the latest techniques, instrumentation, and methods to analyze a wide variety of complex testing challenges.
Customer Service
Our whole team is committed to completing each customer's project to their exact specifications, including custom methods and rush services.
Instrumentation
Avomeen's investigations include the use of FT-IR, GC/MS, LC/MS, HPLC, NMR, SEM/EDXA, ICP, AA, TGA, DSC, and many other techniques.
Contact Us
Avomeen Analytical Services
4840 Venture Drive
Ann Arbor, MI 48108
Phone: 1-800-930-5450
Fax: 1-800-930-5479
Email: scientist@avomeen.com