Analysis of Pemetrexed Disodium for Injection Reference Listed Drug
To analysis the reference listed drug of Pemetrexed disodium for injection through literature research and reverse engineering experiments.By reviewing and analyzing the FDA instructions,EMA,and PMDA review information of the reference listed drug,the prescription composition and other information of the reference listed drug were preliminarily obtained;methods such as high-performance liquid chromatography and the 2020 edition of the General Principles of the Chinese Pharmacopoeia were used to detect the critical quality attribute of the three batches of reference listed drugs,including related substances etc.,The main impurities in the reference listed drug of Pemetrexed disodium for injection were Pemetrexed ketone and impurity BC;The excessive dosage of Pemetrexed in the reference listed drug is 8.5%,which meets the clinical requirement of not less than 100 mg in the instruction manual;The test results all meet the requirements of the Chinese Pharmacopoeia for injections.The prescriptionand Critical to quality attributes of the listed drug of Pemetrexed disodium for injection were comprehensively analyzed,providing reference for the industry to carry out consistency evaluation.
pemetrexed disodium for injectionreference listed drugreverse engineeringconsistency evaluation
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万方数据
