Pemetrexed 3-Oxo Diacid Impurity

Pemetrexed 3-Oxo Diacid Impurity product with CAS: 193281-05-9 is also known as N-[4-[3-(2,6-Diamino-1,4-dihydro-4-oxo-5-pyrimidinyl)-3-oxopropyl] benzoyl]-L-glutamic acid. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. It is used in Pemetrexed impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, N-[4-[3-(2,6-Diamino-1,4-dihydro-4-oxo-5-pyrimidinyl)-3-oxopropyl] benzoyl]-L-glutamic acid is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.