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Cover of the European Pharmacopoeia, 11th Edition. The European Pharmacopoeia [1] (Pharmacopoeia Europaea, Ph. Eur.) is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. [1]
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
Pharmacopeial reference standards are available from various pharmacopoeias such as United States Pharmacopeia and the European Pharmacopoeia. Where pharmacopoeial tests or assays call for the use of a pharmacopoeial reference standard, only those results obtained using the specified pharmacopoeial reference standard are conclusive.
Eudralex,The Rules Governing Medicinal Products in the European Union, European Communities Commission. Directorate-General for Industry, Pharmaceuticals and Cosmetics. Vol. 1: Pharmaceutical legislation: medicinal products for human use.
The 1699 Edinburgh Pharmacopoeia. A pharmacopoeia, pharmacopeia, or pharmacopoea (from the obsolete typography pharmacopœia, meaning "drug-making"), in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.
The British Pharmacopoeia is published on behalf of the Health Ministers of the United Kingdom; on the recommendation of the Commission on Human Medicines, in accordance with section 99(6) of the Medicines Act 1968, and notified in draft to the European Commission (EC) in accordance with Directive 98/34/EEC.
In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles. [1]
Since 2003, a synthetic substitute for the LAL test has been commercially available. This recombinant factor C (rFC) test is based on Limulus clotting factor C, the LPS-sensitive part of LAL. The adoption of this test was slow, which began to change in 2016 when the European Pharmacopoeia listed this test as an accepted bacterial-toxin test. [3]
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