R&D Capabilities in Analytical Development

Analytical method validation and method transfer as per ICH guidelines and FDA requirement for key starting materials, Intermediates & API
US FDA audited and approved analytical laboratory facility with 21CFR Part 11 compliance systems
Polymorphic studies
Polymorphic studies (identification and quantification) using SSNMR, XRPD, DSC
Impurity profiling
Impurity profiling and Quantification at trace levels (Genotoxic impurities in PPB and PPM) using LCMS-MS & GCMS-MS
Isolation of impurities with Prep LCMS and Structural elucidation with Advance instruments (NMR, Mass, DSC, TGA)
Project Life Cycle
Project Lifecycle management support using self equipped advance instruments which will enable us to respond to the regulatory agency on time without depending on any external laboratories
Technical Expertise
Analytical scientists holding rich experience in solving complex analytical problems with minimum turn around time. Competent in advance instruments for method development, analytical method validation, regulatory requirement, and batch release