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analytical testing, has been replaced by “procedure” throughout the document to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)
Posted by Tim Sandle
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