A Checklist For Risk Assessment Of Nitrosamine Impurities In Oral Solid Dose Drugs
A Checklist For Risk Assessment Of Nitrosamine Impurities In Oral Solid Dose Drugs By Amol Galande, Ajay Pazhayattil, and Sanjay Sharma Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) are being identified in high-volume drug products such as valsartan, losartan, irbesartan, and ranitidine at levels well above the acceptable daily intake limits. The credit for identifying the higher NDMA levels goes to an independent pharmacy 1 that tests every batch it dispenses, exposing limitations in drug substance and drug product post-approval change assessment and analysis requirements at p...
Source: pharmaceuticalonline.com