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Central Laboratory Analytical Services (CLAS)
Central Laboratory Analytical Services (CLAS) is a cGMP/GLP compliant and US FDA inspected analytical testing facility established in the year 2019.
We offer a consultative, multi-disciplinary approach as part of analytical services to meet current regulatory requirements
Services we offer
- Analytical Method Development, Analytical Method Validation and Transfer (Assay, Organic Impurities, Enantiomeric Purity, Residual Solvents, Dissolution and Content Uniformity).
- Routine QC tests for raw materials, intermediates, API and Formulation as per Pharmacopoeia and/or client specific methods.
- Polymorphic Identification and quantitation by XRPD technique.
- Elemental Analysis by ICP-MS as per ICH Q3D in line with USP, & EMEA guideline and/or client specific requirement.
- Genotoxic impurity evaluation by a suitable analytical technique, in line with ICH M7 control limit based on TTC approach.
- Nitrosamine impurity quantification of a sensitive and rugged analytical methods by GC-MS/MS and/or LC-MS/MS.
- Extractable & Leachable Studies using different techniques like GC-MS/MS, LC-MS/MS, ICP-MS and Ion Chromatography. Services are performed as per USP (, , ), PQRI recommendations and/or client requirements.
- Q1 and Q2 sameness studies for complex generic products & Reverse Engineering support for Quantitative estimation of selective inactive ingredients in RLD products
- Stability Studies for drug substance and drug products.
List of Instruments
Accreditations
Drug Control Administration
US FDA Inspected
DUNS Registered
INVESTORS DESK