New & Revised USP–NF Standards for Biologics

The following standards have been published in USP–NF or its supplements. (A subscription to USP–NF is required to view these standards.)

• Second Supplement to USP 35–NF 30 (published 01–Aug–2012, official 01–Dec–2012)
  • Goserelin Acetate [NEW]
  • Glucagon
  • Glucagon for Injection
  • Polysorbate 20
  • Polysorbate 40
  • Polysorbate 60
  • <85> Bacterial Endotoxins Test
  • <123> Glucagon Bioidentity Tests [NEW]
  • <1102> Immunological Test Methods—General Considerations [NEW]
  • <1103> Immunological Test Methods—Enzyme-linked Immunosorbent Assay (ELISA) [NEW]
  • <1238> Vaccines for Human Use—Bacterial Vaccines [NEW]
  • This supplement also includes two new chapters for elemental impurities. Visit Key Issue: Elementals Impurities.

• First Supplement to USP 35–NF 30 (published 01–Feb–2012, official 01–Aug–2012)

Associated Pharmacopeial Education course: BioAssay Validation <1032>, <1033> and <1034>