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An inter-company cross-validation exercise on capillary electrophoresis testing of dose uniformity of paracetamol content in formulations

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Summary

Successful transfer of an MECC method for the determination of paracetamol between 7 companies is shown. The method was applied to the quantitative determination of paracetamol levels in capsules. The results obtained agreed well between companies and with both HPLC data and the label claim. Acceptable method performance in terms of relative migration time precision and response factor precision was reported by each company.

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Altria, K.D., Clayton, N.G., Hart, M. et al. An inter-company cross-validation exercise on capillary electrophoresis testing of dose uniformity of paracetamol content in formulations. Chromatographia 39, 180–184 (1994). https://doi.org/10.1007/BF02274498

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  • DOI: https://doi.org/10.1007/BF02274498

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