Identification and control of a degradation product in Avapro film-coated tablet: low dose formulation.

@article{Wang2008IdentificationAC,
  title={Identification and control of a degradation product in Avapro film-coated tablet: low dose formulation.},
  author={George W. Wang and John D. Fiske and Scott P Jennings and Frank P. Tomasella and Venkatapuram A Palaniswamy and Kenneth L Ray},
  journal={Pharmaceutical development and technology},
  year={2008},
  volume={13 5},
  pages={393-9}
}
A degradation product was formed during the long-term stability studies (LTSS) of the low dose formulation of Avapro film-coated tablet. The degradant was identified as the hydroxymethyl derivative (formaldehyde adduct) of the drug substance, irbesartan, based upon analysis with LC/MS, LC/MS/MS, and chromatographic comparison to the synthetic hydroxymethyl degradation product. Laboratory studies demonstrated that the interaction of individual excipients with the drug substance at elevated… CONTINUE READING