Ph. Eur. Grade (European Pharmacopoeia) chemicals
Material that complies with its European Pharmacopoeia monograph, binding across the Ph. Eur. member states.
What the grade means
Ph. Eur. grade material complies with its monograph in the European Pharmacopoeia, published by the European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe. The texts are legally binding in all states that have signed the European Pharmacopoeia Convention, a group wider than the European Union. A new edition appears every three years, with supplements in between.
EP is a common abbreviation for the pharmacopoeia, but some reagent catalogues use it for extra pure. Zemixal writes Ph. Eur. to avoid that confusion.
What a monograph controls
- Definition, content and characters.
- Identification and related substances, often with named specified impurities.
- Residual solvents, elemental impurities, water and sulfated ash.
- Assay and, for excipients, functionality-related characteristics.
When to choose it
Choose Ph. Eur. grade for medicines registered in Europe and in markets that accept European texts. A CEP from EDQM can support the API section of a dossier.
Documentation
Each lot ships with a COA naming the edition or supplement, plus a GHS SDS. Specified impurities are available from Impurity Reference Standards.
Ph. Eur. Grade (European Pharmacopoeia) products
- CAS
- 2376134-25-5
- Formula
- C26H34O8
- MW
- 474.5 g/mol
About Ph. Eur. Grade (European Pharmacopoeia)
Is a Ph. Eur. monograph the same as a BP monograph?
What are specified impurities in a Ph. Eur. monograph?
Does the COA need to state the Ph. Eur. supplement?
Compare with other grades
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