Problems Revealed In Brazil Ampicillin Tests

Tests by the Brazilian consumer institute IDEC have found problems withthe active ingredient in almost half of the ampicillins made by 13 domestic firms, and errors in product labeling. The tests, conducted at Sao Paulo University's Biomedical Sciences Institute, followed reports on various domestic brands by a quality control organization.

Ampicillins are among the most widely-sold antibiotics in Brazil; there are about 80 different brands on the market. The 13 brands tested came, as capsules and tablets, from EMS, Bergamo, Bunker, Legrand, Luma, Sedabel, SIF, Teuto, UQFN and Luper e Bayer and, as suspensions, from EMS, Furp, UQFN and Wyeth.

The problems are said to include the proportions of active ingredient in various dosages; in some cases this had suffered degradation or chemical change. Uniformity testing found discrepancies with the weights of standard capsules of 454mg-685mg, and 71mg-1.028mg for standard tablets. IDEC pharmacologist Rogerio Renato Silva said this showed a failure to maintain a satisfactory relationship between ampicillin's weight (500mg) and the product's total weight. Most of the problems here came from Bunker and SIF.