Development and Validation of analytical methods for Assay, Related substances, Genotoxic and carcinogenic impurities, Residual solvents, Inorganic impurities, Particle characterisation etc. as per ICH Q2. on various hi-end analytical techniques like HPLC (equipped with UV, RI, DAD and CAD detectors), Gas chromatography, LC-MS, GC-MS, ICP-MS, Ion Chromatography (Equipped with Conductivity and Pulsed Amperometric detectors)
Estimation of genotoxic and carcinogenic impurities like Nitrosamines using High-end LC-MS and GC-MS employing validated analytical methods in drug substances and drug products.
Stability studies are conducted at various temperature and humidity conditions for different climate zones. Photostability is conducted as per ICH Q1B guidelines.
Physicochemical tests like osmolarity, particle size analysis, melting point, solubility etc are provided.
Extractables and Leachable studies are done for pharmaceutical products, devices and pharmaceutical manufacturing components addressing rubber, polymer and plastic additives that usually constitute pharmaceutical packaging and delivery systems. The studies are done as per USP<1663>, <1664> employing high end equipment like LC-MS, GC-MS, ICP-MS, IC and extraction systems.
Elemental impurities in drug substances and drug products are estimated as per ICH Q3D, USP<232>, <232> using latest ICP-MS
Testing of APIs, Formulations and Excipients are done as per various pharmacopoeias using methods that are validated/verified under strict adherence to quality systems.
Particle size distribution in dry and wet dispersion is performed using Malvern master sizer-3000 by a team with good knowledge on micromeritics.
We offer analytical services from the product design, development, stability to commercialization stage including developing specification and methods for impurities and genotoxic impurities in addition to offering analytical support throughout product lifecycle.
i)Analytical Support for Dossier/DMF fillings
ii)Analytical support for Regulatory Queries :
We support regulatory deficiencies related Analytical Queries.