Grades and purity
EP grade (European Pharmacopoeia)
Definition
Material that meets the European Pharmacopoeia (Ph. Eur.) monograph, legally binding in its member states.
The European Pharmacopoeia is published by the EDQM, part of the Council of Europe, and applies in the countries that signed its convention, including all EU member states. It is often written Ph. Eur.
API makers selling into Europe often hold a certificate of suitability (CEP) from the EDQM, which shows that their material is adequately controlled by the Ph. Eur. monograph.
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.
- USP grade (United States Pharmacopeia)Material that meets the USP or NF monograph, the drug and excipient standards recognised in US law.
- 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.
- CEP (certificate of suitability)A certificate from the EDQM confirming that an API's quality is suitably controlled by the European Pharmacopoeia monograph.