Compendial testing verifies pharmaceutical and biologic drug substances and products against recognized pharmacopeial standards, including USP-NF, European Pharmacopoeia, Japanese Pharmacopoeia and British Pharmacopoeia.
Bringing pharmaceutical and biologic products to market depends on consistent, pharmacopeia-aligned testing at every stage of development and manufacturing. Aligning to multiple compendial standards while meeting method transfer, batch release, stability and process validation timelines adds complexity to drug substance and drug product testing programs.
We provide routine physicochemical, microbiological and analytical testing for pharmaceutical and biologic drug substances and finished products, performed in accordance with USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), British Pharmacopoeia (BP) and client-specific specifications, supporting your product from early development to commercial manufacturing.
Support your compendial testing program
- Confirm compendial complianceVerify your drug substances and products against USP-NF, Ph. Eur., JP, BP and client-specific specifications.
- Support your full product lifecycleAccess consistent testing from early development and method transfer through quality control, batch release, stability programs and commercial manufacturing.
- Strengthen quality control decisionsDraw on physicochemical, chemical and microbiological testing to support consistent batch release and quality control outcomes.
- Advance process validation with confidenceBase your process validation activities on data generated through compendial and validated analytical methods.
- Maintain robust stability programsApply consistent compendial methods to support stability testing across each stage of your product lifecycle.
Discover our compendial testing services
- Physicochemical testingWe assess appearance, pH, osmolality, water content, particulate matter and other physicochemical attributes defined in pharmacopeial monographs.
- Chemical and analytical testingWe determine assay, potency, related substances, residual solvents and elemental impurities, and perform identification through compendial HPLC, GC, UV and FTIR methods.
- Microbiological testingWe perform sterility, bioburden, bacterial endotoxins, microbial limits, preservative efficacy and mycoplasma testing to support product safety and compliance.
Why SGS?
As the world's leading testing, inspection and certification company, we combine pharmacopeial expertise with global laboratory capacity to support your compendial testing program.
Our teams apply compendial and validated methods across physicochemical, chemical and microbiological disciplines, helping you meet USP-NF, Ph. Eur., JP and BP requirements consistently across development, quality control and commercial manufacturing.
FAQs
We provide physicochemical, chemical and analytical, and microbiological testing for drug substances and finished products, including assay and potency determination, impurity testing, sterility testing and microbial limits testing.
Compendial testing supports the full product lifecycle, including early development, method transfer, quality control, batch release, stability programs, process validation and commercial manufacturing.
We test against USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), British Pharmacopoeia (BP) and client-specific specifications.
16th Floor, Block A, No.73 Fucheng Road, Century Yuhui Mansion,
Beijing, Haidian District, China