Friday 16 October 2015

Review of USP38 NF33 2ndSupplement

Review of USP38 NF33 2nd Supplement – effective 01 December 2015

The USP–NF is a single–volume combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Monographs for drug substances and preparations are featured in the USP. Excipient monographs are in the NF.

General Tests and Assays
Apparatus for Tests and Assays

Chapter 31      Volumetric Apparatus - Use and Standards of Accuracy

Biological Tests and Assays

Chapter 111    Design and Analysis of Biological Assays

Chemical Tests and Assays

Chapter 232    Elemental Impurities – Limits: Introduction, Routes of Exposure, Drug Products, Drug Substance and Excipients, and Analytical Testing.

General Information

Chapter 1223  Validation of Alternative Microbiological Methods


Trehalose - Nitrogen Determination, Method II

Sodium Chloride - Arsenic, Method I; Barium; Ferrocyanides; Limit of Bromides; Limit of Phosphates; Magnesium and Alkaline-Earth Metals; and Sulfate; Appearance of Solution, Bacterial Endotoxins Test, and Sterility Tests; Packaging and Storage, Labelling, and USP Reference Standards (added).

Soybean Oil - Identity by Triglyceride Profile, Test B (added); Fats and Fixed Oils, Sterol Composition (deleted) and Sterol Composition (added)

Posted by Tim Sandle

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