Batch-To-Batch consistency in the quality attributes of a Phyto-Pharmaceutical Ma001 used to treat Typhoid in Ghana

Abstract

In pharmaceutical manufacturing, products are made using standard operating procedures which are specific for each product. As a result, it is expected that, any number of batches of the same product selected at random for evaluation should either have the same results for all tested criteria or the difference between them should be within the acceptable limits. Batch-to-batch consistency study of herbal products is an important quality control parameter for assessing their reproducibility, efficacy and safety profile. This study sought to assess the batch-to-batch consistency of MA001, a herbal product using parameters such as colour, odour, taste, pH and total solid residue. Other assays conducted on the products included UV spectrometry and HPLC fingerprinting. Elemental analysis of the three batches of MA001 were selected for the study. The results from this study showed that, the products from the different batches had the same physico-chemical parameters as specified by the manufacturer. Ultimately, the sampled batches passed the batch-to-batch consistency test, hence, the reproducibility, efficacy and safety of MA001 decoction is assured.