Release Testing Labs

Product 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 biopharmaceutical product meets a pre-determined set of specifications. These often include verification of the formulation’s identity, potency and purity, impurities, uniformity, identity, presentation attributes, and sterility.

Our laboratory is FDA-Registered & Inspected, GLP/GMP-Compliant, Reach/RoHS-Compliant, and DEA-Licensed (Class I-V)
What Products Require Release Testing to Meet GMP Compliance?

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

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

Routine Release Testing Services Include:

  • Pharmacopeia Monographs
  • API Identify Confirmation
  • Compendial Testing (USP, EP, JP, Etc.)
  • 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-Chemical Properties & Other Compendial Testing Including:

  • Appearance
  • Degree of Coloration
  • Loss on Drying
  • Clarity/Opalescence pH
  • Particulates/Particulate Matter
  • Density
  • Turbidity
  • Sterility
  • Bacterial Endotoxins
  • Extractable Volume
  • Osmolality & Moisture
  • Assay

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.

Work with us to make health & medicine better for everyone.

Start a quote or ask an experienced scientist today.