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Compendial & Non-Compendial Testing

Compendial Testing (Pharmacopeias)

Compendial monograph (pharmacopeial) tests are standardized methods and specification testing for pharmaceutical raw materials and finished products. Testing and compliance to the standards detailed within compendial methods is a basic requirement for manufacturing release and distribution of pharmaceutical ingredients and drug products around the world.

We blend regulatory acumen and an “always available” mindset to provide our clients unparalleled quality, compliance, and customer service to support the efficient release of finished products as well as the qualification of raw materials, active pharmaceutical ingredients (APIs), and excipients for production and manufacturing. All compendial testing is performed in our Stability and Release Testing Labs per cGMP standards of 21 CFR 210 and CFR 211.

You will have full access to our consultative technical team of CMC experts who are well versed in regulatory requirements and have years of experience testing to USP compendial methods and FDA monographs. Additionally, we will maintain a seamless partnership, bringing you together with a single dedicated project management lead.

Stability & Release Testing Methods & Applications

Compendial Testing Applications Standardized Methods Used
  • Full Monograph Testing
  • US Pharmacopeia-National Formulary (USP/NF)
  • Raw material testing (USP/NF, EP, JP, BP)
  • European Pharmacopoeia (EP)
  • Drug Substance
  • Japanese Pharmacopoeia (JP)
  • Finished Drug Product
  • British Pharmacopoeia (BP)
  • ICH Stability Studies (API & Finished Products)
  • Dissolution Studies
  • American Chemical Society (ACS)
  • Physiochemical Testing
  • AOAC
  • Particle Size Distribution Determination
  • Stability Indicating Assay and Related Substances Methods
  • Methods Verification per USP <1226>
  • Methods Validation per USP <1225> if needed
  • Container-Closure Qualifications
  • Microbiological Testing

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