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)