COMPARATIVE EVALUATION OF EXCIPIENTS FROM DIFFERENT VENDORS AND THEIR IMPACT ON IDENTIFIED FORMULATIONS

The aim of present work is focused to develop an alternate vendor by comparative evaluation of excipients from different vendors and through their im pact on identified formulations . Comparison of excipients from different vendors is based on a preliminary specification comparison, analytical results comparison and thorough evaluation of excipient based on its functional characteristics and later on a w orst case formulation with respe c t to excipient tested is identified out of numerous formulations and the evaluated data is extrapolated for the re s t of the formulations. Four excipients were identified based on their criticality and their functionality te sts were developed based on their functional role in their respective formulations. Fro m the observed results, it wa s concluded that the difference between the functional test results obtained from the existing and proposed source were less than 1 % for al l the four excipients. From the results obtained it can be con cluded that the proposed vendor materials for all the four excipients evaluated were equivalent with that of the existing vendor material s and therefore can be accepted as an alternate source.