A process for analyzing and identifying siRNA sequences and their production impurities using LC-HRAM-MS and BioPharma Finder software. The method was optimized for chromatographic separation of impurities and ISQ EM signal, and impurities were confirmed using Orbitrap Exploris 240 mass spectrometer and oligonucleotide sequencing analysis. The process is transferable to a quality control setting for routine analysis and generates a comprehensive report on sample purity for each primary component, including co-eluting impurities and their relative abundance.
The Thermo Scientific UltiMate 3000 RS HPLC System is applied for the chiral purity of (S)-Isomer in Vilanterol Trifenatate. The analysis was performed on a Thermo Scientific Hypersil Chiral IGT HPLC column using an in-house method. The result obtained for resolution between S-isomer and Vilanterol Trifenatate is 4.12.The results obtained for system suitability were 2.37 for the S-isomer and Vilanterol Trifenatate were 1.0 and 1.02 respectively.
The Thermo Scientific Vanquish Flex UHPLC system is applied for the chromatographic purity analysis of Cefpodoxime Proxetil. The results obtained for the resolution between the peaks due to S-epimer and R-epimer was 4.5 (USP criteria of minimum 4.0) and theoretical plates for R-epimer were 25,623 (USP criteria of minimum 19,000). By modernizing an older USP monograph after the regulation provided in USP General Chapter <621>, the run time can be reduced by 64% and solvent consumption can be lowered by almost 74% by simply migrating to a 3µm column.
Demonstrates the determination of inorganic anions in drinking water by IC with built-in peristaltic pump for regenerant flow to a chemical suppressor.
This work demonstrates a five-minute analysis method to determine inorganic anions in drkinking water by an integrated, single-channel compact IC.