Improved Drug Impurity ID Efficiency under CMC using 2-D LC/MS (Technical Report Vol.39)
The analytical method development section in CMC (Chemistry, Manufacturing andControl) department of pharmaceutical company constitutes part of the pharmaceutical developmental process that deals specifically with the physical nature of a drug substance and the drug product, how it is made, and the control of the manufacturing process to provide reliable and reproducible product. HPLC systems in these areas are utilized for the specification tests of active pharmaceutical ingredients (API) to insure the quality of the product as well as the level of impurities.
- Content Type:
- Application
- Document Number:
- C146-E149A
- Product Type:
- Mass Spectrometry, Liquid Chromatography, Liquid Chromatograph-Mass Spectrometry
- Keywords:
- CMC, Drug product, manufacturing process, API, QA/QC,2D-LC/MS, Pharmaceutical, Life Science, Drug synthesis and purification, DMPK, ADME, Safety testing, 2D-LC/MS Impurity ID System
- Language:
- English
- File Name:
- jpl212013.pdf
- File Size:
- 2,540kb
