Pharmaceutical Testing
To be the world’s most trusted partner for Quality Assurance.
Pharmaceutical Testing
To be the world’s most trusted partner for Quality Assurance.
Method Development and Validation
- Genotoxic Impurity [“Nitrosamine Impurities”] quantification studies
- Elemental Impurities by ICP MS as per ICH Q3D & USP 232
- Extractable & Leechables as per FDA guidelines
Pharmacopeia Testing
- Raw materials
- Excipients
- Active pharmaceutical ingredients(APIs)
- Bulk Drugs
- Finished products
- Medical Devices
Chemical Testing
- Assay by HPLC/GC
- Residual Solvents
- Heavy Metal analysis by AAS/ ICP MS
- Physico-chemical properties
- Lactulose Testing
- Voglibose Testing
- Testing tritimetry test by LCMSMS
- Dissolution studies
- Particle Size Analysis
- Dissolution studies
- Water Content by Karl Fischer
Microbiological Testing
- Limit tests as per Harmonised protocol
- Sterility Testing
- Test for specific micro-organisms
- Antibiotics / VItamins Assay
- Bacterial Endotoxins Test as per LAL/Gel clot method
- Allergens like Gluten, Beta lactoglobulin etc. by ELISA
- MLT, BET, Sterility method Validations
- Dissolution tests
Toxicology Testing
- Toxicity
- Acute Toxicity
- X Factor testing
- Haematological Study
- Allergens Study
- Glycemic Index Study
- Comparative Study
- Microbial assays
- Sampling and analysis of water for pharmaceutical microbiology
- Chemical disinfectant testing and cleaning studies
- Microbial identification
Stability Testing
- Stability studies as per ICH guidelines
- Support in designing studies for real-time, stress tests and photostability studies
- Development and validation of stability indicating methods
- Examination of stability-relevant parameters
- Storage and management of stability samples
- Interim reports for every testing period
- Comprehensive final report
