LESUN PHARMA’s analytical chemists offer high-quality analytical services including comprehensive analytical testing support for process development and drug product manufacturing, method development and validation, qualification of reference standards, testing and release studies, stability studies, impurity isolation and identification.

CGMP Compliant Method Development/Validation & Quality Studies

●Analytical method development, method validation and qualification

●Analytical technology method transfer

●Supportive tests for process studies and manufacture

Analytical Services

ICH Stability Studies for Drug Substance & Drug Product

●Dedicated stability facilities. Calibrated stability room equipped with auto-alarm and backup power systems

●ICH stability studies for drug substance and drug product include preparation and approval of stability protocols, sample management, sample testing, data and trend analysis and preparation of reports

●Stability indicating analytical technology method validation and transfer

Filing Document Preparation

●CFDA/TGA/FDA dossier filling support

Impurity Isolation & Identification

●Isolation of impurities in starting materials, intermediates, APIs and drug products using efficient separation techniques including preparative HPLC

●Isolation of the degradation products of APIs from forced degradation studies

●Impurity identification and analysis based on customers’ needs