Analytical method development and validation is a crucial components of any pharmaceutical development program using suitable technique for the qualitative and quantitative estimation through the establishment of product specification and its shelf life.
Validated methods establish clear limitations of application by verifying the process is robust enough so that the slight variations between operators or between laboratories do not have an impact on results.
Our analytical method development and validation services include:
Analytical method development and validation services are performed as per ICH Q2, USP <1225>, method verifications as per <1226>, and/or customer requirements.
We provide identification, Assay, Related substance, Dissolution, Content uniformity, Residual solvents, Polymorphic quantification, Particle size distribution, Elemental (Q3D), and Genotoxic impurity determinations etc.
Techniques used are HPLC (UV, RI, FLD, PDA), UPLC, GC-HS (FID, ECD), Dissolution Apparatus, pXRD, PSA, GC-MS/MS, HS-GC-MS, LCMS, ICPMS, ICPOES, AAS and IC.
We perform analytical method development and validation testing on:
Active Pharmaceutical Ingredients (APIs) / Drug Substance
