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4.24H DISSOLUTION TEST FOR HERBAL DRUG PREPARATIONS

Introduction

          This test is provided to determine compliance with the dissolution requirements where stated in the individual monograph for herbal drug preparations, except where the label states that tablets are to be chewed. See “Dissolution Test” (Appendix 4.24) for description of apparatus used, Apparatus Suitability Test and other related information. Of the types of apparatus described in “Dissolution Test” (Appendix 4.24), use the one specified in the individual monograph.

          Compliance with dissolution requirements necessitates the testing of six dosage units individually, or testing two or more dosage units in each of the six vessels of the dissolution apparatus and measuring the dissolution of the compound(s) specified in the individual monograph.

Procedure

          Combine equal volumes of the filtered solutions of the six or more individual samples withdrawn, and use the pooled sample as the test solution. Determine the average amount of the marker compound(s) dissolved in the pooled sample by the prorcedure specified in the individual monograph. Make any necessary modifications, including concentration of the analyte in the volume of the test solution taken. Use the dissolution medium for preparation of the standard solution and dilution, if necessary, of the test solution.

APPENDICES • 4.24H DISSOLUTION TEST FOR HERBAL DRUG PREPARATIONS
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