NABL accredited analytical testing lab in India

Analytical Research and Development

ANALYTICAL CAPABILITIES

US FDA approved Analytical Research Development testing lab in India

Well-equipped analytical facility running on 24/7 basis to support R&D team

State of the art facility, modernised labs with latest Equipment

NABL accredited analytical testing lab in India

Well equipped lab with the following instruments

Dedicated team and facility for separation and purification
of difficult compounds (Enantiomers, Close eluting compounds
and many more)

Impurity Profiling

Impurity profiling involves a comprehensive process that begins with the identification of impurities, followed by their isolation and purification.

Once isolated, each impurity undergoes detailed characterization and structure elucidation (SER) to understand its properties and potential impact. The final step involves synthesis, enabling further study and regulatory compliance. This end-to-end approach ensures product safety, quality, and consistency.

Analytical Research Development

Related FAQs

We have all the below listed accreditation to support for analytical filings to US FDA, EMA, MHRA, Health Canada , ANVISA etc.

  • US FDA (Latest EIR September 2024- DUNS/FEI no.: 864393104/3008465427
  • NABL ISO/IEC 17025:2017-Certificate no.:TC-16273
  • ICS ISO 9001:2015-Regristeration no.:RQ91/7577
  • GLP and SDC/State FDA- Certificate no 19-LAB-HR

  • ICP-OES – Make/Model: Perkin Elmer Optima 8000
  • ICP-MS – Make/Model: Agilent 7800
  • HPLC – Make/Model: Waters Alliance e2695, Waters 2489 (Arc) with UV/Vis, RI, and PDA detectors
  • UPLC – Make/Model: Waters Acquity UPLC H-Class
  • FTIR – Make/Model: Perkin Elmer Spectrum Two
  • GC (FID, TCD, ECD, NPD) – Make/Model: Perkin Elmer Clarus 580; Agilent 7980A with HS 7694E
  • Stability Chambers – Make/Model: Newtronic
  • LC-MS – Make/Model: Waters Acquity SQD2
Test Parameter Development & Validation Timeline
Assay and Identification 3–4 weeks
Related Substances / Organic Impurities 6–8 weeks
Elemental Impurities 3–4 weeks
Residual Solvents 3–4 weeks

ICH Q9 and FMEA (Failure Modes Effects Analysis) guideline-Reference SOP no QA023R2

Yes we can offer Method transfer of the Validated method

  • Direct Method Transfer – Onsite
  • Indirect Method Transfer – Remote
  • Co-Validation

Get in touch with us

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