A (17.beta.)-Estra-1,3,5(10)-triene-3,17-diol 17-valerate CEP of the European Pharmacopoeia monograph is often referred to as a (17.beta.)-Estra-1,3,5(10)-triene-3,17-diol 17-valerate Certificate of Suitability (COS). The purpose of a (17.beta.)-Estra-1,3,5(10)-triene-3,17-diol 17-valerate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of (17.beta.)-Estra-1,3,5(10)-triene-3,17-diol 17-valerate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of (17.beta.)-Estra-1,3,5(10)-triene-3,17-diol 17-valerate to their clients by showing that a (17.beta.)-Estra-1,3,5(10)-triene-3,17-diol 17-valerate CEP has been issued for it. The manufacturer submits a (17.beta.)-Estra-1,3,5(10)-triene-3,17-diol 17-valerate CEP (COS) as part of the market authorization procedure, and it takes on the role of a (17.beta.)-Estra-1,3,5(10)-triene-3,17-diol 17-valerate CEP holder for the record. Additionally, the data presented in the (17.beta.)-Estra-1,3,5(10)-triene-3,17-diol 17-valerate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the (17.beta.)-Estra-1,3,5(10)-triene-3,17-diol 17-valerate DMF.
A (17.beta.)-Estra-1,3,5(10)-triene-3,17-diol 17-valerate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. (17.beta.)-Estra-1,3,5(10)-triene-3,17-diol 17-valerate 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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