9326896755 [email protected]

Pharmaceutical Laboratory

banner-smlbg
slidergrass

"A new State-of–Art facility for analytical services with wide ranging analytical capabilities in chemical & Microbiology is set up at Goa Location for conducting tests on drugs and raw material used in Pharmaceuticals manufacturing on behalf of licensees (Customers) for manufacture for Sale of drugs. Wide-ranging capabilities inclusive of high-end instrumentation conforming to 21 CFR Part 11. • Qualified scientific team with capabilities in project management catering to global clients"

Sadekar Pharmaceutical QC Laboratory

Sadekar Pharmaceutical QC Laboratory

"Testing Today for Safer Healthcare Tomorrow."

Dedicated to delivering high-quality analytical and microbiological testing solutions, supporting pharmaceutical manufacturers in meeting regulatory standards and product quality requirements.

Pharmaceutical QC Laboratory - Services Offered

  • Analytical method development, Analytical method validation & Force Degradation studies, Analytical method transfer for API and FPs. Routine Analysis of APIs, FPs & consumer healthcare products as per Validated/Verified method of analysis.
  • Impurities & Dissolution profiling.
  • Optical rotation, titration, Refractive Index, Loss on drying, Identification tests etc.
  • Cleaning method development/validation
  • Stability Management (Storage covering ICH/Non-ICH, Sample Analysis)
  • Regulatory Query Management
  • Microbiology Services – Sterility testing, BET, MLT, Micro Assay, method validation, Microbiological quality of water, Preservative efficacy test.
  • Testing as per current IP/BP/EP/USP method as well as customer specification.
  • Elemental impurities analysis at ultra-trace levels for pharmaceuticals and consumer products using ICP-MS
  • Nitrosamine, Unknown peak identification by LC-MSMS/UHPLC
  • Assay, Dissolution, UC & Related substances by HPLC (PDA/RI detector)
  • Estimation of residual solvents and organic volatile impurities using GCMS-FID/TCD
  • Residual solvent/ Molecular estimation by GCMSMS with Headspace
  • Potentiometric Assay water content by Autotitrator
  • Dissolution profile for tablets & capsules using dissolution apparatus with auto samplers
  • Optical rotation by Digital polarimeter
  • Refractive Index by Digital refractometer

    • Stability- Chambers: :
    • 25ºC/60%RH • 40ºC/75%RH • 30ºC/65%RH • 30ºC/75%RH.

    Pharmaceutical QC Laboratory – Microbiology :
    •Microbial limit test •Total Microbial count •Preservative efficacy test •Sterility testing •Micro Assay •Bacterial Endotoxin test.