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 limitatio...
Ajay Pazhayattil Sanjay Sharma Amol Galande Development Lab At Lupin Technology Transfer Formulations At Lupin Aims To Control Nitrosamine
Source: pharmaceuticalonline.com