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