Purpose-Built cGLP Architecture
Designed from the ground up for strict contamination control, vibration isolation, and continuous 24/7 data fidelity.
HVAC & Cleanroom Air Handling
Independent AHUs with HEPA filtration providing continuous positive pressure differentials, temperature control (22±2°C), and humidity containment.
Vibration-Isolated Balance Suite
Heavy granite anti-vibration tables physically isolated from building resonance, supporting 6-decimal microbalances with calibrated NABL weights.
Continuous Redundant Power
Dual online UPS systems backed by an automated diesel generator ensure continuous stability storage and uninterrupted 72-hour HPLC sequences.
Biometric Security & Controlled Archives
Role-based electronic access controls, climate-controlled fireproof sample vaults, and write-once immutable storage for physical and digital data.
Analytical Equipment & Instrumentation
Explore our validated suite of analytical instruments. Filter by testing discipline or search for specific technologies.
LC-MS/MS (Triple Quadrupole)
⚙️Xevo TQ-S micro
Nitrosamines (NDMA, NDEA, NDSRI), Extractables & Leachables (E&L), genotoxic trace impurities in APIs.
HPLC with UV/PDA Detector Suite
⚙️Alliance e2695 & Agilent 1260 Infinity II
API assay, degradation product profiling, dissolution quantification, and swab cleaning validation.
HPLC with Fluorescence Detector (FLD)
⚙️1260 Infinity II FLD
Fluorescent impurity tracking, aflatoxins, vitamins, and specialized polymer additives.
HPLC with Refractive Index (RI) Detector
⚙️Waters 2414 RI Detector
Sugars, polysaccharides, PEG excipients, and polymers lacking UV chromophores.
GC-FID with Automated Headspace Sampler
⚙️7890B GC + 7697A Headspace Sampler
Residual solvent quantification in APIs and drug formulations per USP <467> and ICH Q3C.
GC-MS (Single Quadrupole)
⚙️5977B MSD with 7890B GC
Volatile organic extractables & leachables, unknown identification, and pesticide residue profiling.
ICP-MS (Inductively Coupled Plasma Mass Spectrometry)
⚙️7900 ICP-MS
Class 1 (As, Cd, Hg, Pb), Class 2A, 2B, and Class 3 elemental impurities per ICH Q3D and USP <232>/<233>.
ICP-OES (Optical Emission Spectrometry)
⚙️Avio 200 Dual-View ICP-OES
Heavy metal screening, catalyst residues (Pd, Pt, Rh), and high-throughput raw material verification.
Closed-Vessel Microwave Digestion System
⚙️Multiwave GO
Exhaustive sample mineralization of difficult API matrices, polymers, and packaging for ICP-MS testing.
Double-Beam UV-Vis Spectrophotometer
⚙️UV-1900i
Identity confirmation, colorimetry, assay, and dissolution absorbance measurements.
FT-IR Spectrophotometer with ATR Module
⚙️Spectrum Two FT-IR with Diamond ATR
Rapid non-destructive identification of APIs, packaging polymers, elastomer seals, and raw materials.
Atomic Absorption Spectrophotometer (AAS)
⚙️240FS Fast Sequential AA
Targeted heavy metal verification (Lead, Cadmium, Arsenic, Mercury) for pharmacopoeial monographs.
Automated Franz Diffusion Cell System (12-Cell)
⚙️FDC-12 Automated Transdermal System
In-Vitro Release Testing (IVRT) and In-Vitro Permeation Testing (IVPT) for creams, gels, and transdermal patches.
Precision 6-Cell Franz Diffusion Cell Array
⚙️V-Series Stirrer with Jacketed Cells
Pilot formulation screening, membrane compatibility evaluations, and synthetic skin permeation studies.
Dissolution Apparatus USP I & II with Autosampler
⚙️EDT-08Lx with Disso Sample Collector
Immediate and extended release tablet/capsule dissolution, multimedia curves (pH 1.2, 4.5, 6.8), and f2 similarity calculations.
USP IV Flow-Through Dissolution System
⚙️CE 7 Smart Flow-Through System
Poorly soluble APIs, liposomes, nanoparticles, implants, and modified-release injectables.
Total Organic Carbon (TOC) Analyzer
⚙️TOC-L CPH High-Sensitivity System
Purified Water and WFI testing per USP <643>, and cleaning validation swab/rinse organic carbon determination.
ICH Zone I & II Climatic Chamber (25°C / 60% RH)
⚙️ICH 1000L Walk-In & Reach-In Suite
Long-term real-time stability storage for temperate climate pharmaceutical and OTC products.
ICH Zone IVB Climatic Chamber (30°C / 75% RH)
⚙️High-Capacity Stability Chamber
Long-term stability storage for hot and humid climatic zones (India, ASEAN, Latin America).
ICH Accelerated Stability Chamber (40°C / 75% RH)
⚙️Stress & Accelerated Stability Suite
Accelerated 6-month shelf-life projection and stress degradation trigger evaluations.
ICH Photostability Chamber (Option 2 Light Source)
⚙️Photostability 500L Unit
Photostability testing of APIs, tablets, and packaging containers per ICH Q1B.
Validated Cold Storage Suite (2–8°C & -20°C)
⚙️Ultra-Low & Cold Pharmaceutical Chambers
Cold-chain stability storage for biologics, peptides, enzymes, and temperature-sensitive APIs.
Karl Fischer Moisture Titrator (Volumetric & Coulometric)
⚙️870 KF Titrino Plus with Oven Sampler
Accurate water content determination in hygroscopic powders, lyophilized cakes, and volatile organics.
Laser Diffraction Particle Size Analyzer
⚙️Mastersizer 3000 with Hydro EV Wet Dispersion
Particle size distribution (D10, D50, D90) for micronized APIs, suspensions, and dry powder inhalers.
Tour Our Ahmedabad Testing Center
We welcome sponsor qualification audits, technical visits, and pre-study consultations at our Baleshwar City facility.