A MULTINATIONAL SURVEY OF THE QUALITY OF CARBAMAZEPINE TABLETS

The results of a multinational survey of the quality of carbamazepine tablets are reported. A total of 22 laboratories in nineteen countries worldwide participated in the study conducted under the auspices of t he Official Laboratories and Medicines Control Services (OLMCS) Sectio n of FIP. The results of tests conducted on 86 samples representing at least 34 different products, comprising the innovator's product Tegre tol, 13 other branded products and 20 generic products, are presented. Most products fulfilled the requirements of pharmacopoeial quality st andards. However, there were marked differences in dissolution behavio ur which suggest that not all products are bioequivalent with each oth er. Most of the products tested would not comply with a requirement fo r the percentage of carbamazepine released at 15 minutes, that is prop osed for inclusion in the USP monograph for Carbamazepine Tablets.