Tuesday, 29 January 2013

Pharmacopeia Forum Vol. 39 (2013)

A new edition of the Pharmacopeia Forum Vol. 39 No.1 Jan– Feb 2013 has been published. Among the items of interest for laboratory staff are:

Chapter 202 Identification of Fixed Oils by Thin-Layer Chromatography [NEW]

(Revision proposal target, USP37-NF32)

This new chapter proposes an orthogonal test to determine the identity of fixed oils. The procedure is harmonized with European Pharmacopoeia general chapter 2.3.2. Identification of Fatty Oils by Thin-Layer Chromatography

Chapter 231 Heavy Metals

(Revision proposal target, USP37-NF32)

To improve and harmonize monographs and general chapters, the USP proposes to omit Heavy Metals chapter 231 and all references to this general chapter from USP–NF monographs and other general chapters. USP is replacing <231> with two new general chapters on elemental impurities:

Chapter 232 Elemental Impurities—Limits
Chapter 233 Elemental Impurities—Procedures

These two chapters were published in the Second Supplement to USP 35–NF 30

Chapter 853 Flourescence Spectroscopy [NEW]

(Revision proposal target, USP37-NF32)

Spectrophotometry and Light–Scattering <851> will be replaced by a family of chapters pertaining to atomic absorption, UV–Vis, infrared, and fluorescence spectroscopy methods. Each of these chapters will be presented in pairs (one numbered below 1000 and one numbered above 1000). Chapter <853> is based on application of the method when applied to a procedure in a monograph. Its sections are Introduction, Instrument Qualification, Procedure, and Validation and Verification

Chapter 1853 Flourescence Spectroscopy – Theory and practice [NEW]

(Revision proposal target, USP37-NF32)

The general information chapter describes theory and instrumentation used to support development of a compendial procedure. That chapter's sections are Theory, Instrumentation, Factors That Affect Quantitation, Calibration of Fluorescence Instruments, and Procedure Validation