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- W4386695145 abstract "Sterile pharmaceutical products are produced under strict compliance with good manufacturing practices (GMP). The purpose of process validation is to provide documented evidence that the pharmaceutical system that is capable of continuously supplying the clean and conditioned air with the specified quality attributes and establish its dependability of cytosterile injection facility. Topotecan (Hycamtin) is an anticancer agent that is a topoisomerase inhibitor. It is a synthetic, water-soluble analog of the natural chemical compound camptothecin. This work is aimed to establish documentary evidence to demonstrate the anticancer drug topotecan hydrochloride process validation, under defined set of operating conditions are capable of producing the finished product as per the finished product specifications. The data generated were checked, compiled, and critically reviewed based on the final results. It has been observed that all the critical process parameters and analytical results for process validation batch are well within the limits and correlated with the expected compliance parameters" @default.
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- W4386695145 date "1970-01-01" @default.
- W4386695145 modified "2023-09-29" @default.
- W4386695145 title "Process Validation of Lyophilized Formulation of the Anticancer Drug Topotecan" @default.
- W4386695145 doi "https://doi.org/10.37285/ijpsn.2016.9.4.7" @default.
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