- Method development & validation (MD/MV) ICH Q2R (1), USP <1225>, ORA guidelines.
- Method verification and Method transfer USP <1224>, USP <1226>.
- Packaging Material Testing, USP < 661.1>, USP <661.2>.
- Regulatory Batch Release.
- API and Excipients analysis as per USP, BP and IP.
- Stability testing as per ICH Q1.
- Reverse Engineering.
- Dissolution studies.
- Residual Solvent analysis as per USP <467>
- Metal Impurities USP <233>
- Formulation Product development studies.
- Physical characterisation.
- Forced degradation studies.
- Testing of materials as per Pharmacopeia.
- Reference standard Characterization.
- Working Standard preparation.
- Cleaning or residue Method Development and Validations.
- Extractable and Leachable studies as per guidelines.
Our state of art Analytical facility is equipped with below mentioned Instruments.
- ICP-MS 7800 - Agilent
- Particle Size Distribution - Malvern 2000
- HPLC Waters and Agilent with PDA / RS / FLD Detectors.
- FT-IR - Bruker Tensor
- GC - Auto Liquid Injector/HSS - Shimadzu
- GC-Auto Liquid Injector FID & TCD Detector - Agilent
- TOC-Analyzer - Shimadzu
- UV Spectrophotometer - Shimadzu
- Potentio metric Titrator - Spectra lab
- Dissolution with auto sampler - lab India
- Viscometer (Rotational), Model DV-II + Pro - Brookfield
- Ion Chromatography - Dionex
- Particle Size Distribution - Malvern 3000