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USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF).
- Technical Support
USP–NF Online; USP–NF Mobile App; USP–NF USB Flash Drive;...
- USP-NF Standard Updates
The United States Pharmacopeia–National Formulary (USP–NF)...
- Pharmacopeial Forum
PF is a free bimonthly online journal in which USP publishes...
- Notices
USP–NF Compendial Notices are designed to inform...
- Resources
The Rules and Procedures of USP's Council of Experts specify...
- Accelerated Revisions by Official Date
Revision Bulletins are posted by the first of each month....
- Publication & Comment Schedule
(The USP–NF is also published as a Spanish Edition.View...
- Revision Bulletins
Revision Bulletins are published in USP–NF Online by the...
- Technical Support
Learn about the latest revisions, harmonization, and reference standards of the USP-NF, the official compendium of pharmaceutical standards in the United States. Find out how to access the USP-NF online, subscribe to updates, and order USP reference standards.
This chapter provides guidance on the design and validation of immunoassays for residual host cell proteins (HCPs) in biopharmaceuticals. It covers the terminology, methods, reagents, and supporting technologies for HCP detection, identification, and measurement.
The USP is published in a combined volume with the National Formulary (a formulary) as the USP-NF. [2] . If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation "USP" or "NF".
USP–NF 2022, Issue 2. Deferrals. (link is external) (posted 19–Nov–2021) Cancellations. (link is external) (posted 19–Nov–2021) Revisions. (link is external)
The United States Pharmacopeia – National Formulary (USP-NF) includes over 5000 quality standards for medicines, both chemical and biologic; active pharmaceutical ingredients (APIs); and excipients (inactive ingredients).
The only official version of the United States Pharmacopeia-National Formulary (USP-NF) Online is found at online.uspnf.com/uspnf and the only official version of the Food Chemicals Codex (FCC) Online is found at www.foodchemicalscodex.org .