New edition of the USP

A new edition of the USP has recently been issued: USP36-NF31. The changes of interest are:

General Chapters

Listed are items in which changes have been made to existing official text.

General Tests and Assays

Chapter 1        Injections

Revision to the following sections: Foreign and Particulate matter.

Physical Tests and Determinations

Chapter788     Particulate Matter in Injections

Revision to the following sections: Introduction and Method 1 Light Obscuration Particle Count Test.

Chapter 921    Water Determination

Revision to the following sections: Method I (Titrimetric and Method II (Azeotropic – Toluene Distillation), General information.

Chapter1051   Cleaning Glass Apparatus

Introduction and appendix have been added.

Chapter 1197 Good Distribution Practices for Bulk Pharmaceutical Excipients [NEW]

NF31: Monographs

Caprylic Acid [NEW] (Octanoic acid)

For further details, see USP.

Posted by Tim Sandle