Data Integrity in the Pharma Space

Discover the supremacy of the bioinert coated hardware of YMC Accura BioPro IEX QF columns for reproducible analysis of oligonucleotides in ion-exchange chromatography.

This application note demonstrates the use of SCION's 8500GC system for the analysis of key greenhouse gases—carbon dioxide, methane, and nitrous oxide—in a single atmospheric air matrix. Highlighting the system's excellent sensitivity and repeatability, this method is crucial for understanding emission sources and combating climate change.

This application note outlines a method for detecting low levels of 1,4-Dioxane, a likely carcinogenic compound, in drinking water using SCION GC-MS technology. It details the procedure for analyzing water samples spiked with 1,4-Dioxane, achieving excellent sensitivity and low detection limits, demonstrating the method's effectiveness for environmental monitoring.

This application note from SCION Instruments delves into the meticulous screening of impurities in plant protection products using GC-FID, with GC-MS for confirmation. It emphasizes the necessity of identifying and quantifying impurities to comply with regulatory standards in industries such as pharmaceuticals, food, and agriculture. The study specifically examines eugenol, showcasing how to determine significant impurities for regulatory submission. The approach integrates GC-MS and analytical standards, ensuring precise impurity identification and quantification critical for product approval.

We show the development of HPLC-ELSD methods for high-throughput and sensitive analysis of the lipids in lipid nanoparticles (LNPs), used to administer mRNA vaccines.

Recycling chromatography is a powerful technique that allows the separation of two closely eluting peaks by increasing the column bed length.