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