A 20, Polysorbate CEP of the European Pharmacopoeia monograph is often referred to as a 20, Polysorbate Certificate of Suitability (COS). The purpose of a 20, Polysorbate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 20, Polysorbate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 20, Polysorbate to their clients by showing that a 20, Polysorbate CEP has been issued for it. The manufacturer submits a 20, Polysorbate CEP (COS) as part of the market authorization procedure, and it takes on the role of a 20, Polysorbate CEP holder for the record. Additionally, the data presented in the 20, Polysorbate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 20, Polysorbate DMF.
A 20, Polysorbate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 20, Polysorbate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of 20, Polysorbate suppliers with CEP (COS) on PharmaCompass.