Monday 4 August 2014

Pharmacopeial Forum 40 (3) – items of interest

Pharmacopeial Forum 40 (3) – items of interest

Items of interest are:

General chapters

202:     Identification of Fixed Oils by Thin-Layer Chromatography (Revision proposal target, USP38-NF33 1st Supplement)

A new chapter to determine the identity of fixed oils to be used as an orthogonal test in the Identification section of the monograph. The chapter has been harmonized with the European Pharmacopoeia general chapter 2.3.2. Identification of Fatty Oils by Thin-Layer Chromatography.

1010:   Analytical Data- Interpretation and Treatment (Revision proposal target, USP38-NF33 1st Supplement)

Revision of this chapter is proposed. In Use of Reference Standards new text is introduced to clarify the use of secondary Reference Standards. A new Appendix F is being added to explain the use of two one-sided tests (TOST) to assess equivalency of analytical procedures. The term “method”, when referring to analytical testing, has been replaced by “procedure” throughout the document to align with current USP terminology.

1029:   Good Documentation Guidelines (Revision proposal target, USP38-NF33 1st Supplement)

This proposed new general chapter provides guidelines on how to develop and maintain good documentation practices within Good Manufacturing Practice (GMP) operations.

1228.1: Dry Heat Depyrogenation (Revision proposal target, USP38-NF33 1st Supplement)

Parenteral products not only need to be sterile, but also free from harmful levels of pyrogens, or fever-causing agents. For an overview of depyrogenation, see general information chapter Depyrogenation 1228. Of the several modes of depyrogenation, dry heat is employed for the depyrogenation of heat stable materials. Dry heat depyrogenation is a temperature- and time-dependent process. Depyrogenation using dry heat can be accomplished in a batch oven mode or in a continuous process using a tunnel system. Depyrogenation in ovens is typically performed at temperatures in excess of 170°. Tunnels for depyrogenation ordinarily operate at higher temperatures. This new chapter proposal provides an overview of the process, routine process control, and its validation.

Posted by Tim Sandle

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