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Within the framework of the Procurement, Quality and Sourcing Project for HIV, Tuberculosis and Malaria (http://www.who.int/prequal), The International Pharmacopoeia is collaborating with manufacturers, independent analytical drug quality control laboratories, national and regional pharmacopoeial bodies, research, governments, and regulatory bodies to provide specifications and monographs for tuberculosis medicines. A draft monograph for rifampicin and isoniazid tablets (below) is now being circulated for consultation. Please forward any comments to: Quality and Safety: Medicines, World Health Organization, 1211 Geneva 27, Switzerland or [email protected].
Category. Antituberculosis drugs.
Storage. Rifampicin and isoniazid tablets should be packaged in airtight containers, protected from light.
Additional information. Strengths in the current WHO Model List of Essential Medicines:
60 mg rifampicin and 30 mg isoniazid.
150 mg rifampicin and 75 mg isoniazid.
300 mg rifampicin and 150 mg isoniazid.
60 mg rifampicin and 60 mg isoniazid.
150 mg rifampicin and 150 mg isoniazid.
REQUIREMENTS
Complies with the monograph for "Tablets" (see Vol. 4, p. 26*).
rifampicin and Isoniazid tablets contain not less than 90.0% and not more than 110.0% of the amounts of rifampicin (C^sub 43^H^sub 58^N^sub 4^O^sub 12^) and isoniazid (C^sub 6^H^sub 7^N^sub 3^O) stated on the label.
Identity tests
Either test A and B or test C may be applied.
A. See the test described below under "Assay method A". The retention time of the Isoniazid peak in the chromatogram of solution A corresponds to that in the chromatogram of solution B.
B. See the test described below under "Assay method B". The retention time of the Rifampicin peak in the chromatogram of solution A corresponds to that in the chromatogram of solution B.
C. Carry out the test as described under "Thin-layer chromatography" (Vol. 1, p. 83*), using silica gel R5 as the coating substance and a mixture of 100 volumes of methanol R and 1.5 volumes of strong ammonia solution R as the mobile phase. Apply separately to the...