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Limiting residual solvent levels in active substances, excipients and medicinal products The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has adopted Impurities Guidelines for Residual Solvents which prescribes limits for the content of solvents which may remain in active substances, excipients and medicinal products after processing. This guideline, the text of which is reproduced below, excludes existing marketed products. The European Pharmacopoeia is, however, applying the same principles enshrined in the guideline to existing active substances, excipients and medicinal products whether or not they are the subject of a monograph of the Pharmacopoeia. All substances and products are to be tested for the content of solvents likely to be present in a substance or product. If the use of a Class 1 solvent has been justified and authorised then it is to be limited in the test section of the individual monograph. Normally monographs of the Pharmacopoeia will not include limit tests for individual solvents belonging to Class 2 since the solvents employed may vary from one manufacturer to another. Therefore, the competent authority is to be informed of the solvents employed during the production process. This information is also given in the dossier submitted for a certificate of suitability of the monographs of the European Pharmacopoeia and is mentioned on the certificate. [ Last edited by golkey on 2008-11-3 at 20:33 ] |
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golkey
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2楼2008-11-03 20:33:26