Journal of chemotherapy
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Journal of chemotherapy · Sep 2018
Comparison of pharmaceutical quality of eight generic ganciclovir injections in China and Cymevene.
To assess the pharmaceutical quality of eight commercially available generic products of ganciclovir injection produced in China with original brand product (Cymevene, Roche, Switzerland). Tests were performed according to China Pharmacopoeia 2015 and Import Drug Registration Standard introduced by CFDA. Items including characteristics of the packing and reconstituted solution, pH, visible particles, content of active and related substances, sterility and bacterial endotoxin were all carried out based on the standard laboratory operating rules and requirements. ⋯ In addition, six generic products failed to reach the quality requirements of water content, which should be under 3%. Most tested ganciclovir products failed to meet the pharmaceutical quality standards for original brand product. Important items like pH, endotoxin contamination, content of API and impurities could cause clinical attention, as they directly affect the therapeutic efficacy and patient tolerance.