Comprehensive Analytical Testing Services
12 specialized cGLP testing services under one roof - spanning pharmaceutical method validation, trace elemental impurities, and extractables & leachables, backed by FDCA Gujarat State Form 37 approval and global regulatory standards.
Showing 12 testing disciplines
Pharmaceutical Testing
Complete testing of APIs, formulations, excipients & finished products as per USP, EP, BP, IP, and ICH guidelines.
Analytical Method Development & Validation
Stability-indicating, residual solvent, dissolution, and cleaning validation methods per ICH/FDA/USP guidelines.
Extractable & Leachable (E&L) Studies
Assessment of drug-container interactions using LCMS/MS, GCMS, and ICPMS. Data accepted by US & EU regulators.
Elemental Impurity Testing
ICH Q3D-compliant testing of elemental impurities in APIs, drug products, and raw materials using ICP-OES and ICP-MS.
Nitrosamine / NDSRI Testing
Detection of nitrosamine traces in APIs and drug products using LC-MSMS. Compliant with FDA/EMA requirements.
IVRT & IVPT Studies
In-Vitro Release Testing and In-Vitro Permeation Testing for topical semi-solid products using Franz diffusion cells.
Stability Studies
ICH-compliant long-term, accelerated, and stressed stability studies with 24/7 monitored climatic chambers.
Chemical Analysis
Comprehensive wet chemistry and physico-chemical testing for pharmaceuticals, water, food, and industrial samples.
Water Analysis
Chemical, microbiological, and trace element testing of drinking water, purified water, WFI, and effluent samples.
Dissolution Profiling Studies
Comparative, multimedia, and method development dissolution studies for solid oral dosage forms per USP and FDA guidance.
Residual Solvent Testing
Headspace GC and direct injection GC methods for Class 1, 2, and 3 residual solvents in APIs and drug products.
Cleaning Method Validation
Validation that equipment is free from API residues and detergents between production batches, as per FDA cGMP guidelines.