Grades and purity
Pharmacopoeia monograph
Definition
The official standard for a medicine or ingredient in a pharmacopoeia, listing its tests and acceptance limits.
A monograph sets out the identity tests, assay, impurity limits and other requirements a substance must meet to be sold under that pharmacopoeia's name. It refers to general chapters for the test methods.
When a supplier says a product is IP, BP, USP or EP grade, it means each batch is claimed to meet the current monograph of that pharmacopoeia. Ask which edition is used and check the certificate of analysis for real results against each monograph test.
Related terms
- 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.
- USP grade (United States Pharmacopeia)Material that meets the USP or NF monograph, the drug and excipient standards recognised in US law.
- 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.