Quality control of anti-tuberculosis FDC formulations in the global market: Part II – accelerated stability studies
METHODS: Formulations across different companies and combinations were subjected to 6-month accelerated stability testing in packaging conditions recommended by the manufacturer. Various pharmacopeial and non-pharmacopeial tests for tablets were performed for 3- and 6-month samples.
RESULTS: All the formulations were found to be stable, where extent of dissolution was within ±10% of that of the initial value, and all formulations passed the pharmacopeial limits for assay and content uniformity of 90–110% and ±15% of average drug content, respectively.
CONCLUSIONS: Good quality RMP-containing FDCs that remain stable after 6-month accelerated stability testing are available in the marketplace.
Document Type: Regular Paper
Affiliations: Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Mohali, Punjab, India
Publication date: 2005-11-01
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