A 1,3,7-Trimethylxanthine CEP of the European Pharmacopoeia monograph is often referred to as a 1,3,7-Trimethylxanthine Certificate of Suitability (COS). The purpose of a 1,3,7-Trimethylxanthine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 1,3,7-Trimethylxanthine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 1,3,7-Trimethylxanthine to their clients by showing that a 1,3,7-Trimethylxanthine CEP has been issued for it. The manufacturer submits a 1,3,7-Trimethylxanthine CEP (COS) as part of the market authorization procedure, and it takes on the role of a 1,3,7-Trimethylxanthine CEP holder for the record. Additionally, the data presented in the 1,3,7-Trimethylxanthine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 1,3,7-Trimethylxanthine DMF.
A 1,3,7-Trimethylxanthine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 1,3,7-Trimethylxanthine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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