We offer comprehensive pharmaceutical analysis services, including methodology development and verification, analytical testing and release, stability study, scale separation, and CMC filing documents.
Various chromatographic techniques (HPLC, UPLC, GC, and IC) and detection techniques (UV, MS, MS/MS, ELSD, FID, fluorescence, etc.) to satisfy different compound typesAnalytical and detective methods of contents and/or related substances for stability study on API and pharmaceutical preparations (tablets, capsules/liquid capsules, liquid preparations/emulsions, powder preparations, pills/coated pills, injections, topical drugs, solid dispersants, etc.)Other special detection methods, such as dissolution (IR, ER and MR), solvent residue, genotoxic impurities, enantiomeric separation, ion chromatography, microbiological test, etc.Experimental design in method development, progress reports, method verification schemes and verification reports, and drug analysis methodsCorresponding solutions for each stage of IND/CTA or NDA/MAA filings
Medicilon has a GMP labs for release inspections, analytical method verification, and stability study.