A tablet with total weight 100 mg contains 50 mg of drug substance (50% w/w). Can the uniformity of dosage units test be demonstrated by weight variation test in the specification for finished product?

刊登日期：2019-11-22 | 點閱次數 : 1895 次

Yes. For above-mentioned tablet (50 mg of drug substance; 50% w/w), the uniformity of dosage units can be demonstrated by weight variation test according to Ch. P. (3016) and USP <905>.

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Drugs Medical Devices Consultation Services Health Technology Assessment International Cooperation

A tablet with total weight 100 mg contains 50 mg of drug substance (50% w/w). Can the uniformity of dosage units test be demonstrated by weight variation test in the specification for finished product?

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