Transfer of USP normal phase method for the analysis of cortisone acetate to the Nexera UC SFC system

The United States Pharmacopeia (USP) monographs are widely referenced to ensure the quality of drug substances. The USP monographs offer reliable and robust methods. However, some of these methods, especially those using normal phase HPLC, require the use of harmful, even toxic solvents. Naturally, laboratories are looking to reduce the use of such solvents for health and safety, as well as cost reasons.
This application note shows an example of the analysis of cortisone acetate tablets according to the USP monograph. The original normal phase method was transferred to SFC with a conventional HPLC column, Shim-pack CLC-SIL, and also a UHPLC phase, Shim-pack XR-SIL using the Nexera UC SFC system.

Content Type:
Paper
Document Number:
PO-CON1572E
Product Type:
Liquid Chromatography
Keywords:
cortisone acetate, United States Pharmacopeia, Pharmaceutical, Life Science, Manufacturing, QA/QC, Nexera UC
Language:
English
File Name:
sil215025.pdf
File Size:
311kb

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