Review
of USP38 NF33 1st Supplement – effective 01 August 2015
The
USP–NF is a single–volume combination of two official compendia, the United
States Pharmacopeia (USP) and the National Formulary (NF). Monographs for drug
substances and preparations are featured in the USP. Excipient monographs are
in the NF.
General
Tests and Assays
Biological Tests
and Assays
Chapter
161 - Medical Devices- Bacterial Endotoxin and Pyrogen Tests
Physical Tests
and Determinations
Chapter
1010 - Analytical Data – Interpretation and Treatment
Introduction,
Prerequisite Laboratory Practices and Principles, Measurement Principles and
Variation, Outlying Results, Comparison of Analytical Procedures, Appendix B,
Appendix C, Appendix D, Appendix E, Appendix F, and Appendix
Chapter
1229.11 Vapour Phase Sterilization [new chapter]
Chapter
1663 Assessment of Extractables Associated with Pharmaceutical
Packaging/Delivery Systems [new chapter]
Chapter
1664 Assessment of Drug Product
Leachables Associated with Pharmaceutical Packaging/Delivery Systems [new
chapter]
Monographs
Polysorbate 20 - Assay –
Composition of Fatty Acids
Alanine - Organic
Impurities (deleted) and Related Compounds (added)
Posted by Tim Sandle
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