High-precision chromatography, mass spectrometry, spectroscopy, elemental analysis, and environmental stability chambers equipped with 21 CFR Part 11 compliant CDS.
Waters Alliance & Shimadzu Prominence UHPLC with PDA, UV-Vis, and Fluorescence Detectors.
Assay, Impurities & DissolutionAgilent 7890B Gas Chromatograph with Headspace Auto-sampler & Flame Ionization Detector.
ICH Q3C Residual SolventsErba ELISA microplate reader with multi-wavelength detection for enzyme-linked immunosorbent assays.
Immunoassays & SerologyAgilent 7900 ICP-MS for ultra-trace elemental quantification (USP <232>/<233>).
Heavy Metals & Trace ElementsPerkinElmer FTIR with Diamond ATR module for rapid non-destructive identification.
Raw Material FingerprintingDouble-beam UV-Vis spectrophotometers with 1nm bandwidth for quantitative assays.
Assay & Dissolution ProfilingShimadzu TOC-L Analyzer for Total Organic Carbon quantification down to 4 ppb.
Purified Water & Swab CleaningMalvern Mastersizer 3000 wet and dry particle size distribution measurement.
API & Powder MicronizationWalk-in stability chambers (25°C/60%RH, 30°C/65%RH, 40°C/75%RH) with 24/7 data logging.
Accelerated & Real-time StabilityLab India dissolution testing system (USP Apparatus I & II) with automatic sampling and temperature control.
In-vitro Drug ReleaseLab India volumetric & coulometric Karl Fischer titrator for precise moisture and water content determination.
Moisture & Water Content