How Do You Derive an Acceptable Intake Limit for a Novel NDSRI with No Existing Toxicology Data?
Introduction: Deriving an NDSRI Acceptable Intake Limit for a novel nitrosamine drug substance-related impurity with no existing toxicology data is […]
Does Drug Product Formulation and pH Affect Nitrosamine Formation Risk?
Introduction: Nitrosamine formation risk in drug products is an important quality and patient safety issue because certain nitrosamines are classified
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Sample Preparation and Extraction Techniques for Nitrosamine Analysis: SPE, LLE, and Headspace Methods
Introduction: Nitrosamine sample preparation and extraction is the single most consequential step in generating defensible, low-level impurity data — get
Nitrosamine Risk Assessment for Peptide APIs and Drug Products: Where NDSRIs Actually Come From
Introduction A comprehensive Nitrosamine Risk Assessment for Peptide APIs examines the specific chemical pathways through which reactive secondary and tertiary
Case Study: Building a Nitrosamine Testing Program from Scratch for a Generic Drug Portfolio of 15 Products
Introduction Developing a Nitrosamine Testing Program from scratch for a multi-product generic drug portfolio requires a well-organized, cross-functional strategy that
Case Study: NDSRI Identification, Potency Prediction, and Confirmatory Quantification for a Novel NDA Submission
Introduction Executing NDSRI Identification, Potency Prediction, and Confirmatory Quantification represents an important regulatory milestone for obtaining New Drug Application (NDA)
How Are Acceptable Intake (AI) Limits for Nitrosamines Calculated? Toxicology, TD50, and the Carcinogenic Potency Approach
Introduction Acceptable Intake (AI) Limits for Nitrosamines Calculation is performed through linear low-dose extrapolation using rodent TD50 carcinogenicity bioassays or
Case Study: Nitrosamine Root Cause Investigation and Reformulation Strategy for an Injectable Drug Product
Introduction: Nitrosamine root cause investigation for injectable drugs is a critical analytical and pharmaceutical-development activity whenever a nitrosamine impurity is
Case Study: Nitrosamine Risk Assessment for a Proton Pump Inhibitor Seeking ANDA Approval
Introduction A comprehensive Nitrosamine Risk Assessment for a Proton Pump Inhibitor seeking Abbreviated New Drug Application (ANDA) approval requires a
Case Study: NDSRI Quantification at Ultra-Low Levels for a Drug with a 10 ng/day Acceptable Intake Limit
Introduction NDSRI Quantification at Ultra-Low Levels requires advanced liquid chromatography-tandem mass spectrometry (LC-MS/MS) methodologies capable of detecting mutagenic impurities at