Introduction: Nitrosamine formation risk in drug products is an important quality and patient safety issue because certain nitrosamines are classified […]
Does Drug Product Formulation and pH Affect Nitrosamine Formation Risk? Read More »
Introduction: Nitrosamine sample preparation and extraction is the single most consequential step in generating defensible, low-level impurity data — get
Introduction A comprehensive Nitrosamine Risk Assessment for Peptide APIs examines the specific chemical pathways through which reactive secondary and tertiary
Introduction Developing a Nitrosamine Testing Program from scratch for a multi-product generic drug portfolio requires a well-organized, cross-functional strategy that
Introduction Executing NDSRI Identification, Potency Prediction, and Confirmatory Quantification represents an important regulatory milestone for obtaining New Drug Application (NDA)
Introduction Acceptable Intake (AI) Limits for Nitrosamines Calculation is performed through linear low-dose extrapolation using rodent TD50 carcinogenicity bioassays or
Introduction: Nitrosamine root cause investigation for injectable drugs is a critical analytical and pharmaceutical-development activity whenever a nitrosamine impurity is
Introduction A comprehensive Nitrosamine Risk Assessment for a Proton Pump Inhibitor seeking Abbreviated New Drug Application (ANDA) approval requires a
Introduction NDSRI Quantification at Ultra-Low Levels requires advanced liquid chromatography-tandem mass spectrometry (LC-MS/MS) methodologies capable of detecting mutagenic impurities at
Introduction: Nitrosamine Risk Assessment for Combination Oral Solid Dosage Forms is particularly important when a pharmaceutical product contains two or
