Solvents used for the DP manufacture

There is no other choice than to use the quality of solvents defined by a Pharmacopoeia. It is true that there are still discrepancies between the pharmacopoeias of different countries. It is hoped that the ICH process dealing with the harmonization of quality, safety and efficacy amongst three main zones of the world (EU, USA, Japan) will progressively reduce the remaining differences in dossiers submitted to Regulatory Authorities and the way the data are evaluated. 

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As for the DS, the solvents used for DP manufacture can produce some negative effects by themselves or through their own impurities. 

Process-related impurities encompass aU possible material that is used during manufacture and which might still be present in the final product These include cell components (e.g., host cell protein, DNA and RNA) and components of the cell culture medium (e.g., antibiotics, inducers, media). In addition, possible downstream-derived components (e.g., enzymes, (bio)-chemical reagents, inorganic salts and solvents) must be considered. Any adventitiously introduced material which is not part of the manufacturing process of either DS or DP is considered as a contaminant. For viral products and processes, special attention is paid to endogenous or adventitious viruses, which should ideally not be present or at least be removed/inac-tivated by the manufacturing process. 

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