Review of USP38 NF33 1st Supplement – effective 01 August 2015

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Sergey
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Review of USP38 NF33 1st Supplement – effective 01 August 2015

Сообщение Sergey » 14 окт 2015 12:53

Review of USP38 NF33 1st Supplement – effective 01 August 2015

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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)

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