Comparison of pharmaceutical quality of eight generic ganciclovir injections in China and Cymevene

Abstract

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. Seven of all tested domestically produced generics of ganciclovir for injection failed to reach the in vitro quality requirements in comparison with the original brand product Cymevene. Three generics failed to meet the standards for pH of an aqueous solution. One out of eight generic products fell outside the specifications for API content. All generics showed impurities, whose levels were generally greater than observed in the brand product. One generic product was identified an endotoxin contamination. 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.

Keywords:

• Ganciclovir
• Generics
• Pharmaceutical quality
• China

Additional information

Funding

This work was supported by the National Major Project of New Drug Discovery [grant number 2017ZX09101001-007-028].