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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 pharmaceutical manufacturing organizations. Certain continuous process improvement changes (for example, Patent # WO/2011/124655, improved process for preparing valsartan) were deemed as the root cause for the higher amounts of NDMA observed. The issue has resulted in the largest product recalls in recent history, affecting brand and generic products alike. The outcome is a reminder ....

Ajay Pazhayattil , Sanjay Sharma , Amol Galande , Development Lab At Lupin , Technology Transfer Formulations At Lupin , Aims To Control Nitrosamine , Limit Potential Carcinogenic Risk , Potential Route , Guidance Control , Nitrosamine Impurities , Human Drugs , Root Sources , Process Development Lab , Technology Transfer , சஞ்சய் ஷர்மா , அமோல் கலந்தே , வளர்ச்சி ஆய்வகம் இல் லூபின் , தொழில்நுட்பம் பரிமாற்றம் சூத்திரங்கள் இல் லூபின் , பொடெந்ஶியல் பாதை , வழிகாட்டல் கட்டுப்பாடு , மனிதன் மருந்துகள் , வேர் ஆதாரங்கள் , ப்ரோஸெஸ் வளர்ச்சி ஆய்வகம் , தொழில்நுட்பம் பரிமாற்றம் ,