Grades and purity
USP grade (United States Pharmacopeia)
Definition
Material that meets the USP or NF monograph, the drug and excipient standards recognised in US law.
The United States Pharmacopeia and National Formulary (USP and NF) are published by the US Pharmacopeial Convention, an independent non profit organisation. USP monographs cover drug substances and products, and NF monographs cover excipients. The US FDA enforces them under federal law.
You will often see USP/NF on excipients such as glycerin or propylene glycol. USP also publishes the Food Chemicals Codex for food ingredients.
Related terms
- Pharmacopoeia monographThe official standard for a medicine or ingredient in a pharmacopoeia, listing its tests and acceptance limits.
- IP grade (Indian Pharmacopoeia)Material that meets the monograph of the Indian Pharmacopoeia, the legal drug standard in India.
- BP grade (British Pharmacopoeia)Material that meets the British Pharmacopoeia monograph. The BP includes all European Pharmacopoeia monographs.
- EP grade (European Pharmacopoeia)Material that meets the European Pharmacopoeia (Ph. Eur.) monograph, legally binding in its member states.
- GMP (good manufacturing practice)Rules for making medicines, APIs, food and cosmetics so that every batch is consistently produced and controlled to its quality standard.
- FCC grade (Food Chemicals Codex)Material that meets the Food Chemicals Codex monograph, a widely used standard for food ingredients.