Nitrosamine analysis: Challenges and updated LC-MS/MS solutions

Nitrosamine impurities are classified as “cohort of concern” as per ICH-M7 guidelines. Regulatory agencies recommend steps manufacturers of APIs and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. Regulatory also published analytical testing methods to provide guidance to industry to evaluate mutagenic nitrosamine impurities in many drug substances and drug products. LC/MS/MS inherently is selective and sensitive analytical technique that is well-suited to identify and quantify nitrosamine impurities at very low levels. In this webcast, we will discuss on the conventional nitrosamines and nitroso drug substance related impurities (NDSRIs), their analysis using LC-MS/MS, analytical challenges, and the available solutions from Agilent.

Register Free: https://www.chromatographyonline.com/lcgc_w/nitrosamine

Event Overview:

Nitrosamine impurities are classified as “cohort of concern” as per ICH-M7 guidelines. Regulatory agencies recommend steps manufacturers of APIs and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. Regulatory also published analytical testing methods to provide guidance to industry to evaluate mutagenic nitrosamine impurities in many drug substances and drug products. LC/MS/MS inherently is selective and sensitive analytical technique that is well-suited to identify and quantify Nitrosamine impurities at very low levels. In this webcast, we will discuss on the conventional nitrosamines and Nitroso drug substance related impurities (NDSRIs), their analysis using LC-MS/MS, analytical challenges, and the available solutions from Agilent.

Key Learning Objectives:

• Discuss the advantages of using LC-MS/MS in Nitrosamine impurity analysis workflow
• Address common workflow challenges in Nitrosamine analysis
• Explore some of the developed solutions

Who Should Attend:

• Scientists working on genotoxic impurities
• Pharmaceutical manufacturers interested in Nitrosamine workflow solutions

Speaker:

Prasanth Joseph, PhD
Chromatography Mass spectrometry Product Specialist
Agilent Technologies

Prasanth Joseph joined Agilent in 2015 as application Engineer for LC-MS/MS and has 19 years of experience in the analytical instrumentation industry, specializes in small molecule applications. He received his PhD in Environmental Science from Bharathiar University, India. He also has master’s degree in business administration from the University of Buckingham, UK.

Prasanth Joseph developed many analytical methods in LC-MS/MS to quantify genotoxic impurities in drug substance and products, analysis of extractables and leachables in pharma and food packaging and medical devices and Bioavailability and Bioequivalence (BA/BE) studies in clinical trials. He provided guidance in developing LC-MS workflows for impurity profiling of pharmaceuticals and metabolite identification (MetID) and quantification as a part of ADME/DMPK related studies.

Prasanth Joseph is also well versed with analysis of phytochemicals in botanicals and herbal extracts, food residue screening, and quantitation and analysis of contaminants in environmental samples.

Register Free: https://www.chromatographyonline.com/lcgc_w/nitrosamine