RE: limits for impurities Contribution from Bernd Renger written on 10/9/2008 at 00:26
Original contribution: limits for impurities written by Tareq Taha on 10/7/2008 at 00:34) Synthetic byproducts and precursor molecules are controlled via the API specification.
In addition, the USP monograph for Mefenamic Acid Capsules requires the product to comply with the general monograph <466> Ordinary Impurities. Impurity testing is done via TLC with iodine vapours as visualising agent. The total of any ordinary impurities observed must not exceed 2.0%
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