Division 01
Chemical, Chromatographic & Instrumental Analysis
Full monograph testing of APIs, excipients, bulk drugs, tablets, capsules, injectables, and liquid oral dosage forms.
HPLC Assay & Impurities: Potency, Related Substances, Organic Impurities & Isomeric Purity
Residual Solvents (GC-HS): Class 1, Class 2 & Class 3 volatile solvents as per USP <467> / IP
Elemental Impurities (ICP-OES / AAS): ICH Q3D trace metals (Pb, As, Cd, Hg, Co, V, Ni)
Dissolution & Disintegration: Multi-point dissolution profiling & similarity factor
Spectroscopy & Identification: FTIR-ATR fingerprinting, UV-Vis Assay, Polarimetry & Refractive Index
Physico-Chemical Parameters: Karl Fischer Moisture, Loss on Drying (LOD), Sulphated Ash, pH, Viscosity & Osmolality
Division 02
Microbiological & Sterility Testing Suite
Performed in classified cleanrooms with positive-control isolation and validated media growth promotion testing (GPT).
Sterility Testing (USP <71> / IP): Closed Membrane Filtration & Direct Inoculation in FTM and SCDM
Bacterial Endotoxin (BET / LAL): Gel-Clot limit/semi-quantitative & Kinetic Turbidimetric/Chromogenic
Microbial Limit Test (USP <61>/<62>): TAMC, TYMC, and absence of specified pathogens
Antimicrobial Effectiveness (AET): Preservative Challenge Testing (USP <51> / IP) for multi-dose containers
Microbiological Antibiotic Assay: Cylinder-plate (Agar diffusion) & Turbidimetric potency determination
Cleanroom Validation & EM: Active air sampling, settle plates, contact swabs & compressed gas testing
Division 03
Medical Device & Packaging Validation
Regulatory compliance testing aligned with Indian MDR, ISO 11737, ISO 10993, and ASTM packaging standards.
Bioburden Determination (ISO 11737-1): Ultrasonic/orbital extraction & recovery efficiency validation
EtO Sterilization Residuals (ISO 10993-7): Gas Chromatography quantification of EO, ECH & EG
Sterility & B/F Validation (ISO 11737-2): Product sterility & Bacteriostasis/Fungistasis method suitability
Packaging Seal Integrity: ASTM F88 seal peel strength, ASTM F1929 dye penetration & bubble emission
Accelerated Aging (ASTM F1980): Shelf-life simulation & sterile barrier stability validation
Sub-Visible Particulate Matter: Light obscuration & microscopic particle count (USP <788>)
Division 04
Pharmaceutical Water, ICH Stability & Analytical R&D
Complete water utility qualification, ICH Q1A(R2)/Q1B stability storage, and ICH Q2(R2) method validation.
PW & WFI Compendial Testing: TOC, 3-Stage Conductivity, Nitrates, Heavy Metals, TAMC & Endotoxins
ICH Stability Chambers: 25°C/60% RH, 30°C/65% RH, 30°C/75% RH, and 40°C/75% RH storage & pull-point testing
Photostability Testing (ICH Q1B): Cool white fluorescent & UV exposure confirmation studies
Method Development & Validation: Specificity, Linearity, Precision, Accuracy, LOD/LOQ & Robustness
Cleaning Validation Analysis: TOC & HPLC trace residue recovery from equipment swabs and rinse water
Drinking & Process Water: Complete physico-chemical & bacteriological testing per IS 10500:2012
Division 05
Nutraceuticals, Herbal / AYUSH & Cosmetics Testing
Safety, contaminant, and active phytochemical marker profiling per API (Ayurvedic Pharmacopoeia), FSSAI, and BIS norms.
Heavy Metals by ICP-OES / AAS: Lead (Pb), Arsenic (As), Mercury (Hg), and Cadmium (Cd) per AYUSH limits
Mycotoxins & Aflatoxins: Aflatoxin B1, B2, G1, G2 and Ochratoxin quantification by HPLC-FLD
Pesticide Residue Screening: Organochlorine, organophosphorus, and pyrethroid multi-residue analysis
Active Marker & Vitamin Assay: Water- and fat-soluble vitamins, curcuminoids, withanolides, and polyphenols
Cosmetic Safety & BIS Testing: pH, thermal stability, heavy metals, preservative efficacy & microbial limits
Nutritional & Proximate Analysis: Protein, amino acid profile, dietary fiber, fat, ash & energy value