Residual solvents in the pharmaceutical industry
Residual Solvents
The choice of a suitable solvent may be decisive for the whole pharmaceutical process to guarantee the desired characteristics of a product.
In the manufacture of drug substances or excipients or the preparation of drug products respectively, residual solvents are defined as “organic volatile chemicals that are used or produced in the manufacture” (Guideline ICH Q3C ‘Note for Guidance on Impurities: Residual Solvents’).
The Guideline lists toxicologically acceptable limits for cases where the solvent can not completely be removed from the final product during the manufacturing process.
| Important information on residual solvents |
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For pharmacopeial grade and EMPROVE® products Merck provides all relevant information on residual solvents for its customers. The information about residual solvents which are likely to be present in the product is depicted in our specification, and after testing every single batch in the certificate of analysis. Residual solvents class 1 and 2 are listed in the certificate of analysis with the limits defined by the pharmacopoeias. Class three solvents are summarized with a total limit of < 0.5 %. If residual solvents are not expected, it is clearly indicated that they are excluded by the production process. Information on residual solvents can be provided for further products if the intended use and the available specific information allow for it. |
