Development of a purity control strategy for pemetrexed disodium and validation of associated analytical methodology.

@article{Warner2015DevelopmentOA,
  title={Development of a purity control strategy for pemetrexed disodium and validation of associated analytical methodology.},
  author={Anne E. Warner and Irina Piraner and Heather Weimer and Kevin C. White},
  journal={Journal of pharmaceutical and biomedical analysis},
  year={2015},
  volume={105},
  pages={46-54}
}
Stability-indicating reversed phase HPLC methods have been developed and validated for the determination of 13 potential process and degradation impurities in pemetrexed disodium drug substance (DS) and pemetrexed for injection drug product (DP). This paper describes the development of HPLC-UV impurity methods for drug substance and drug product. Relative response factors (RRF) have been determined using HPLC-UV in tandem with CAD or by NMR detection. Conditions for the generation of system… CONTINUE READING