Comprehensive chemical, physical, and analytical testing for Active Pharmaceutical Ingredients (APIs), excipients, and finished dosage forms conforming to IP, USP, BP, and EP monographs.
Monograph testing of APIs and excipients, identity confirmation, assay, purity, and organic/inorganic impurity testing.
Batch release testing for tablets, capsules, injectables, ointments, and syrups ensuring quality and potency.
Real-time, accelerated, and intermediate stability testing under controlled ICH temperature and humidity chambers.
Custom HPLC, UHPLC, and GC analytical method development for novel drug molecules and complex matrix formulations.
Analytical method validation per ICH Q2(R1) guidelines covering accuracy, precision, specificity, LOD/LOQ, and robustness.
In-vitro dissolution profiling (USP Apparatus 1, 2, 3, 4) for immediate and modified-release solid dosage forms.
Identification, isolation, and quantitation of process-related and degradation impurities using LC-MS/MS.
Swab and rinse sampling analysis, residual detergent quantitation, and MACO (Maximum Allowable Carryover) calculations.
Quantitation of Class 1, 2, and 3 residual solvents using Headspace Gas Chromatography (HS-GC-FID/MS) per ICH Q3C.
Ultra-sensitive NDMA, NDEA, and NDIPA impurity quantitation via High-Resolution Triple Quad LC-MS/MS.
Trace elemental impurities (As, Cd, Pb, Hg, etc.) screening per USP <232>/<233> and ICH Q3D using ICP-MS / ICP-OES.
Stress testing under acid, base, peroxide, thermal, and photolytic conditions per ICH Q1A(R2) for stability-indicating assays.
