USP–NF compendial and monograph testing for drug substances, excipients, and finished products under cGMP. Results with method references, acceptance criteria, and Certificate of Analysis packages for regulatory compliance.
USP–NF compendial/monograph testing for drug substances and excipients, with results reported per USP method references, acceptance criteria, and CoA/summary packages.
Understanding USP–NF and its regulatory significance
USP–NF combines the United States Pharmacopeia (USP) and the National Formulary (NF). Official USP–NF standards support consistent identity, strength, quality, and purity expectations for medicines.
The current version of USP–NF standards deemed official by USP are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Specific standards for individual drug substances, dosage forms, and excipients
Universal test procedures and requirements (e.g., <621> Chromatography, <905> Uniformity)
Compendial methods are verified for suitability in your matrix/product
cGMP documentation with ALCOA-compliant data integrity practices
Request a quote for USP-NF compendial testing. Include the monograph name/number and sample type (API, excipient, or finished product).
Have questions about cGMP testing or USP-NF methods? Our analytical chemistry experts are ready to help.
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