Related to our (persistent!) emphasis on regulatory excellence and complex chemistry capabilities, team members from Neuland Lab’s Analytical Research & Development Department at our R&D Centre developed and validated a method for detecting genotoxic impurities recently published in the February issue of Pharmaceutical Technology. (Read Development and Validation of a Reverse Phase HPLC Method for the Determination of Related Substances in Pemetrexed Di-Sodium Form-IV in Bulk Drug Samples at Pharmtech).
Methods development for the detection of contaminants such as genotoxic impurities matters tremendously to product safety. With every technological advance geared towards improving human health are advances in our understanding of those things that can negatively impact the safety of pharmaceuticals and biopharmaceuticals, and thus negatively impact human health.
In the Pharmaceutical Technology peer-reviewed article,the development of a stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the quantitative determination of potential genotoxic impurities present in pemetrexed disodium (form IV). The method developed was specific in determining the impurities at even lower levels than that of specifications.
Pemetrexed is an anticancer drug indicated in the treatment of non small cell lung cancer and pleural mesothelioma. The availability of a new validated HPLC analytical technique provides a rapid, sensitive and inexpensive method for detection of very low threshold levels of impurities present in this important drug.
Check out the full article over at PharmTech now.