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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.
Pemetrexed's stability and shelf life might be affected by impurities, which could eventually influence the drug's effectiveness and dependability.
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.
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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