PharmTech AI Pulse Check panelists explain why attribution, audit trails, and sign-off matter more than AI watermark detection for GxP quality teams.
|Webcasts|May 13, 2020
Analysis of Genotoxic Nitrosamine Impurities in Pharmaceutical Products using High-Resolution Accurate Mass (HRAM) Mass Spectrometry
Author(s)Thermo Fisher Scientific
Discover how genotoxic nitrosamine impurity analysis can be performed in a cost-sensitive manner using liquid chromatography with high-resolution mass spectrometry to deliver robust, sensitive, and high-throughput assays under GMP conditions. Wednesday, May 13, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing May 13, 2021 Register free
Register free:
Event Overview:
Nitrosamine (genotoxic) impurities have been found in some angiotensin II receptor blocker (ARB) medicines, such as valsartan, and more recently in histamine-2 receptor blocker medicines, such as ranitidine, drawing close scrutiny from FDA, the European Medicines Agency (EMA) and other regulatory bodies.
Gas chromatography–mass spectrometry (GC-MS) has typically been the detection technique of choice; however, not all nitrosamines can be analyzed this way. As the number of known nitrosamines requiring trace level quantitation increases, the greater the need for robust, sensitive, and high-throughput assays to provide a cost-sensitive approach of a single analysis capable of accurately measuring all compounds. The use of liquid chromatography with high-resolution MS (LC-HRMS) allows low level detection and high confidence of a wider range of nitrosamine impurities.
Here we will describe analytical options to solve nitrosamine analysis challenges.
Key Learning Objectives:
- Why is the analysis of genotoxic impurities important?
- How can cost-sensitive genotoxin impurity analysis be delivered using high-resolution mass spectrometry?
- Can high-resolution mass spectrometry be easily implemented under GMP conditions?
Speaker: Jon Bardsley, Pharma & BioPharma Manager, Thermo Fisher Scientific
Time and Date: Wednesday, May 13, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
On demand available after final airing May 13, 2021
Sponsor: Thermo Fisher Scientific
Register free:
Related to this article
Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral development and manufacturing.
This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Richard Jaenisch examines whether FDA's NAM pathway truly shortens drug pipelines or just shifts the evidentiary burden elsewhere.
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.