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Azithromycin USP vs BP vs EP Grade — What Pharmaceutical Manufacturers Need to Know
Azithromycin USP vs BP vs EP Grade — What Pharmaceutical Manufacturers Need to Know
When sourcing Azithromycin API for pharmaceutical manufacturing, the grade specification — USP, BP, or EP — determines which pharmacopoeial monograph the API must comply with. While all three are high-quality standards for pharmaceutical-grade Azithromycin, there are differences in test methods, acceptance criteria, and documentation requirements that matter for regulatory submissions.
Key Differences: USP vs BP vs EP Azithromycin
| Standard | USP (United States Pharmacopeia) | BP (British Pharmacopoeia) | EP (European Pharmacopoeia) |
| Primary Market | USA, Americas | UK, Commonwealth countries | EU, EEA countries |
| Regulator | US FDA | MHRA | EMA |
| Assay Specification | ≥97.0% (anhydrous) | ≥96.0% | ≥96.0% |
| Related Substances | USP limits | BP limits | EP limits |
| DMF Required | Yes (for FDA submissions) | No (CEP preferred) | CEP preferred |
Which Grade Should You Specify?
- Supplying to the USA — specify USP grade. Ensure your supplier has or can reference a US DMF.
- Supplying to EU markets — specify EP grade. A CEP (Certificate of Suitability) from the EDQM is preferred for EU regulatory submissions.
- Supplying to UK post-Brexit — BP grade, though EP is widely accepted.
- Supplying to Brazil, Mexico, Colombia — ANVISA/COFEPRIS/INVIMA generally accept USP or BP grade with CoA documentation.
- Supplying to Australia, Canada — BP or USP grade accepted by TGA and Health Canada.
Aarise Pharmaceuticals supplies Azithromycin API at USP/BP/EP grade — all three specifications available with appropriate documentation for your target market.