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Pemetrexed
References
FAQ's
References
- Taylor, Edward C.; Kuhnt, Dietmar G.; Shih, Chuan; Grindey, Gerald B., N-(pyrrolo[2,3-d]pyrimidin-3-ylacyl)-glutamic acid derivatives, Princeton University, United States, EP432677B1, March 6, 1996
- Rivory, Laurent P.; Clarke, Stephen J.; Boyer, Michael; Bishop, James F., Highly sensitive analysis of the antifolate pemetrexed sodium, a new cancer agent, in human plasma and urine by high-performance liquid chromatography, Journal of Chromatography B: Biomedical Sciences and Applications, Volume: 765, Issue: 2, Pages: 135-140, 2001
Frequently Asked Questions
How are potential Pemetrexed impurities addressed during the development and validation of analytical methods?
During the development and validation of analytical methods, potential impurities in Pemetrexed evaluate the specificity, sensitivity, and selectivity to ensure impurities' accurate identification, quantification, and control following regulatory guidelines and standards.
Can Pemetrexed impurities affect the drug's stability or shelf life?
Pemetrexed's stability and shelf life might be affected by impurities, which could eventually influence the drug's effectiveness and dependability.
How are Pemetrexed impurities recorded and supported in the medication's specifications?
Pemetrexed impurities are recorded and supported in the medication's specifications through comprehensive analytical testing, validation data, and documentation of impurity profiles, limits, and control measures to ensure compliance with regulatory guidelines.
What are the temperature conditions required to store Pemetrexed impurities?
Pemetrexed impurities are stored at a regulated room temperature of 2-8°C or as specified on the Certificate of Analysis (CoA).
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