A survey of the quality of generic clarithromycin products from 13 countries

Objective: This study evaluated the quality of 40 generic clarithromycin pr oducts from Latin America and Asia. Materials and Methods: The generic products were examined visually, assayed by high pressure liquid chromatography for clarithromycin content and impu rities, tested for dissolution properties, and compared with the innovator product manufactured by Abbott Laboratories. Results: This survey found that many generic clarithromycin products are no t equivalent to the innovator product, falling short of the approved, regis tered specifications for the innovator product. Overall, 20% (8 of 40) of a ll generic tablets tested, and 33% (6 of 18) of tablets from Latin America, failed to contain between 95 and 105% of the clarithromycin claimed in the label, thus falling short of the approved registered specification for the innovator product. A total of 70% (28 of 40) of products tested released l ess drug in 30 minutes than did the innovator tablets, although they still met the dissolution specification requiring that 80% of the drug must disso lve in 30 minutes; one generic product failed to meet the specification. A total of 60% (24 of 40) of the generic products tested exceeded the Abbott Laboratories' 3% limit for total impurities in bulk drug, and 70% (28 of 40 ) exceeded the Abbott Laboratories' 0.8% limit for 6,11 di-O-methyl erythro mycin A. Conclusions: These results suggest that generic tablets are not equivalent to the innovator product, raising concerns that clinical trial results achi eved with branded clarithromycin (Abbott Laboratories) should not be extrap olated to generic products.