Tuesday, 17 February 2015

Pharmacopeial Forum 41 (1)

The USP Pharmacopeial Forum has a new update. This is Volume 41, No.1. Of interest in the new issue is:

Chapter 21      Thermometers (Revision proposal target, USP39-NF34): It is proposed to omit this general chapter from USP.

Chapter 856    Near-Infrared Spectroscopy (Revision proposal target, USP39-NF34)

This new general chapter is being proposed as part of the broader initiative to revise the general chapters related to spectroscopy. This chapter provides calibration and qualification criteria for near-infrared (NIR) spectroscopic instrumentation as well as the acceptable procedure validation criteria

Chapter 1119 Near-Infrared Spectroscopy (Revision proposal target, USP39-NF34)

The chapter is to be re-numbered to <1856> and a change of title, Near-Infrared Spectroscopy – Theory and Practice.

Chapter 1790 Visual Inspection of Injections (Revision proposal target, USP39-NF34)

A new general chapter aimed to provide guidance on the inspection of injectable drug products for visible particles. The methods discussed are also applicable to detection of other visible defects that may affect container integrity or cosmetic appearance of the product.

 Posted by Tim Sandle