Introduction: The Nitrosation Assay Procedure (NAP Test) is an experimental approach for investigating the nitrosation potential of amine-containing active pharmaceutical […]
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 A comprehensive Nitrosamine Risk Assessment for Peptide APIs examines the specific chemical pathways through which reactive secondary and tertiary
Introduction A comprehensive Nitrosamine Risk Assessment for a Proton Pump Inhibitor seeking Abbreviated New Drug Application (ANDA) approval requires a
Introduction: Nitrosamine Risk Assessment for Combination Oral Solid Dosage Forms is particularly important when a pharmaceutical product contains two or
Introduction Nitrosamine Leachables Testing is a comprehensive analytical and regulatory process used to evaluate pharmaceutical packaging and drug delivery systems
Nitrosamine Leachables Testing: From Risk Assessment to Confirmatory LC-MS/MS Analysis Read More »
Introduction Nitrosamine Testing for Antidepressants and SSRIs is a specialized analytical and regulatory process designed to detect, quantify, and control
Introduction Nitrosamine Testing for Antibiotics and Beta-Lactam APIs is a specialized analytical mandate focused on the detection, identification, and quantification
Introduction Nitrosamine Risk in Drug-Drug Combination Products has emerged as a significant toxicological challenge because combining multiple active pharmaceutical ingredients
Introduction Nitrosamines from Excipients primarily arise when trace levels of nitrite impurities present in inactive formulation components react with susceptible
