(2003; 148 pages)
3.5 Draft monograph on rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride tablets
The Committee noted the collaboration between WHO and The United States Pharmacopeia in developing this monograph, received the monograph as a working document and approved the recommendations made during a WHO consultation held in Geneva in September 2001, which can be summarized as follows:
• Since the experimental validation of the methods, currently undertaken by WHO, shows that they need to be improved, further investigations should be carried out.
• Less technically demanding analytical procedures, as alternatives to high-performance liquid chromatography (HPLC) for identification and dissolution testing now being developed by WHO, should be described.
• Close cooperation between WHO and The United States Pharmacopeia aimed at improving the monograph should be continued.