A PROPANE-1,2,3-TRIOL CEP of the European Pharmacopoeia monograph is often referred to as a PROPANE-1,2,3-TRIOL Certificate of Suitability (COS). The purpose of a PROPANE-1,2,3-TRIOL CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PROPANE-1,2,3-TRIOL EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PROPANE-1,2,3-TRIOL to their clients by showing that a PROPANE-1,2,3-TRIOL CEP has been issued for it. The manufacturer submits a PROPANE-1,2,3-TRIOL CEP (COS) as part of the market authorization procedure, and it takes on the role of a PROPANE-1,2,3-TRIOL CEP holder for the record. Additionally, the data presented in the PROPANE-1,2,3-TRIOL CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PROPANE-1,2,3-TRIOL DMF.
A PROPANE-1,2,3-TRIOL CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PROPANE-1,2,3-TRIOL 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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