Excite Pharma Services offers release testing (batch analysis) on final drug product, drug substance (APIs) and excipients.

GMP release testing is a necessary requirement to ensure only the highest quality pharmaceuticals are released for sale, supply or export. Batch release testing includes chemical and physical testing, ensuring that the product falls within the specifications determined.

Excite Pharma Services utilizes the ICH Q6A guidelineTest Procedures and Acceptance Criteria for New Drug Substances and New Drug Products” as the standard for all release testing performed in-house.

Typical release testing / batch analysis services include:

  • Pharmacopeia testing
  • Product appearance
  • Identification
  • Assay
  • Related substances
  • Impurities (residual solvents, metals)
  • Microbial limits
  • UV absorbance
  • Product appearance
  • pH
  • Particulate matter
  • Sterility
  • Endotoxins

And more…..

If you have any questions or are interested in more details of our release testing (batch analysis) services, please contact us.