Precision, Validation, and
Regulatory Excellence
Vikasith Lifesciences Analytical Division is equipped with world-class infrastructure designed to ensure the highest levels of accuracy, reproducibility, and regulatory compliance. Our laboratories feature an extensive array of analytical instruments including UPLC and HPLC systems with PDA, UV, ELSD, RI, and fluorescence detectors, LC-MS/MS triple quadrupole systems, and GC-MS/MS with headspace attachments for volatile component analysis. The division also houses ICP-OES, FT-IR, UV spectrophotometers, auto titrators, KF coulometers, and a Malvern 3000 laser diffraction particle size analyzer. In addition, preparative LC, capillary electrophoresis, microbiology labs for water and API testing, and DSC analysis ensure complete control over product characterization.
Our analytical team focuses on method development and validation for purity, assay, and residual solvents. We specialize in impurity identification and characterization, reference standard qualification, and heavy metal analysis as per ICH guidelines. The labs also conduct nitrosamine and GTI method qualification, container closure and stability studies, particle size analysis, and packing material compatibility testing using DSC and FT-IR with ATR. Analytical teams also perform DVS and water activity studies, photo-stability testing, and microbiological testing of APIs and intermediates. Every analytical result supports cGMP release testing and regulatory filings, ensuring complete data integrity and compliance with international standards.
