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Microbiological Products and Analytical Testing
AN ISO 9001: 2015 CERTIFIED ORGANIZATION

Analytical Testing

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Pharmaceutical Testing


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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
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Pharmacopeia Testing
  • Raw materials
  • Excipients
  • Active pharmaceutical ingredients(APIs)
  • Bulk Drugs
  • Finished products
  • Medical Devices
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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
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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
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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
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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