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5.4. RESIDUAL SOLVENTS SOLVENTS

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.

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