Описание: Identification and quantitation of mutagenic impurities like nitrosamines is a “hot topic” in Pharma small molecules. Recently, several manufactured lots of Angiotensin II Receptor Blockers (Sartan) and Ranitidine drugs have been recalled due to the presence of high potency mutagenic impurities (nitrosamines) found in these products as a result of a manufacturing process change. Pharmaceutical companies are coming under increased scrutiny by regulatory authorities to identify and quantify mutagenic impurities in drug products. Recently, the US FDA published analytical testing methods to provide options for regulators and industry to detect nitrosamine impurities in Sartans and Ranitidine drug substances and products. These methods should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission.
In this webinar we will explore the US FDA regulations for the detection of nitrosamines.
Лектор: Chander Mani, Application Engineer, Agilent Technologies, Inc.
Продължителност: 1 час
Дата: 18 март 2020, 15:00 ч. - LC/MS Methods
Не пропускайте да чуете и първата част от тази поредица - GC-MS Methods - Analytical Strategies for the Accurate Determination of Nitrosamines Produced in the Manufacture of APIs and Drugs