Analytical Research Division – “Precision Meets Innovation”
Analytical Research Division (ARD) is a powerhouse of pharmaceutical testing, equipped with cutting-edge instruments and deep scientific expertise with specialization in delivering high-quality, regulatory-compliant analytical data that supports API and Drug product testing. Our state-of-the-art equipment includes:
- Advanced Chromatography: HPLC, UPLC, GC, GCMS, LCMS, HRMS, IC for precise chemical profiling.
- Elemental Impurity Analysis: ICPMS and AAS for accurate trace metal detection.
- API Characterization: Particle size analysis (Malvern 3000), DSC, FTIR, XRD, surface area analysis, and IGC-SEA for polymorphic and physical property evaluation.
- Respiratory Product Testing: Specialized in MDI, DPI, and nasal sprays using NGI and Cascade Impactor for APSD and DDU studies.
- OSD Testing: Full suite of instruments including dissolution testers, DT apparatus, friability and hardness testers.
- Microbiological Analysis service: Comprehensive testing solutions.
- Stability testing with Walk in humidity chambers as per ICH guidelines.
Specialized Studies
We conduct a wide range of analytical studies, including:
- Method Validation
- Forced Degradation Studies
- CMC Studies
- Pharmaceutical Equivalence (Brazil)
- In-Vitro Studies
- Photostability
- Thermal Excursion
- Temperature Cycling
- Add-Mixture Studies
- NG/G Tube Studies
Compliance & Data Integrity
With strict GLP adherence, validated SOPs, and 21 CFR Part 11–enabled systems, ARD ensures complete traceability, robust data integrity, and audit readiness. The integrated approach combines scientific excellence with regulatory precision to deliver comprehensive data packages that support successful submissions and lifecycle management.
