The United States Pharmacopeia (USP) and the National Formulary (NF) are two important references used in the pharmaceutical industry in the United States. The USP is a compendium of drug information and standards for the identity, strength, quality, and purity of drugs and their components, while the NF is a compilation of monographs on the formulation and preparation of drug products.
USP 30
The USP 30 is the current edition of the USP, which was first published in 1820. It is a comprehensive guide to the standards for drugs and their components, including excipients, dosage forms, and packaging. The USP 30 is updated every five years to ensure that it remains current with the latest scientific and technological developments in the pharmaceutical industry.
The USP 30 contains more than 4,000 monographs on drug substances, dosage forms, and compounded preparations. Each monograph provides information on the identity, strength, quality, and purity of the drug or its components, as well as tests and procedures for determining compliance with the standards. The USP 30 also includes general chapters on topics such as dosage forms, packaging, and analytical methods.
The USP 30 is recognized by the United States Food and Drug Administration (FDA) as an official compendium for drugs and their components. The FDA uses the USP 30 to ensure the safety, efficacy, and quality of drugs that are approved for use in the United States.
NF 25
The NF 25 is the current edition of the National Formulary, which was first published in 1888. It contains monographs on the formulation and preparation of drug products, including tablets, capsules, injections, and topical preparations. The NF 25 is updated every five years to ensure that it remains current with the latest scientific and technological developments in the pharmaceutical industry.
The NF 25 contains more than 1,200 monographs on drug products. Each monograph provides information on the formulation, preparation, and testing of the drug product, as well as requirements for labeling and packaging. The NF 25 also includes general chapters on topics such as pharmaceutical calculations, stability, and sterile products.
The NF 25 is recognized by the United States Pharmacopeial Convention (USP) as an official reference for drug products. The USP uses the NF 25 in conjunction with the USP 30 to ensure the quality and consistency of drug products that are manufactured and marketed in the United States.
Conclusion
The USP 30 and the NF 25 are two important references used in the pharmaceutical industry in the United States. The USP 30 provides standards for the identity, strength, quality, and purity of drugs and their components, while the NF 25 provides monographs on the formulation and preparation of drug products. Both references are updated every five years to ensure that they remain current with the latest scientific and technological developments in the pharmaceutical industry. The USP 30 and the NF 25 are recognized by the United States Food and Drug Administration (FDA) and the United States Pharmacopeial Convention (USP), respectively, as official references for drugs and drug products in the United States.
United States pharmacopeia : USP 30. National formulary : NF 25
The USP-NF is a book of public quality standards for drug substances, drug products, excipients, medical devices, and dietary supplements. To date, through the First Supplement, USP 30-NF 25 contains more than 200 new and revised monographs and 23 new and revised general chapters.
The three-volume set is available in December 2006 with access to:
- More than 4,100 USP-NF monographs with official standards are needed for the regulation of drug substances, drug products, excipients, medical devices, and dietary supplements.
- Over 200 general chapters with the full range of tests, procedures, and industry best practices for all phases of pharmaceutical development and manufacturing.
- World-recognized standards that are FDA enforceable for pharmaceutical exports to the United States and used in many other countries.
Compliance with USP-NF promotes standards in providing good quality medicines.
Viewers also Download: British Pharmacopoeia 2019
0 Comments