Genotoxic impurities, Analytical Method development & Validations
- Our Services
- Genotoxic impurities, Analytical Method development & Validations
Focus on Impurity Profiling Elemental to Organic
Facility : Received EIR report from USFDA. Maharashtra FDA Approved
Instruments : LC-MS/MS with PDA Detector with chromeleon Software ICP-MS.
Analytical Services
Genotoxic Impurities as per ICH M7 Method Development, Method Validation & Sample Analysis Mass Identification By Direct Infusion & BY LCMSMS
Elemental Analysis Elemental Impurities as per USP<232>/<233> & ICH Q3D guidelines
Extractables & Leachables
Analytical Method Development & Validation as per ICH Q2(R1).
ICH Q2 R1 – OBJECTIVE Validation of analytical procedures: The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. A tabular summation of the characteristics applicable to identification, control of impurities and assay procedures is included.
“Validation of Analytical Procedures: Text and Methodology (ICH Q2(R1))” published by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human (ICH) is a tripartite harmonized guideline that identifies validation parameters needed for variety of laboratory .
Analytical methods need to be validated or re-validated before their introduction into routine use: whenever the conditions change for which the method has been validated (e.g., an instrument with different characteristics or samples with a different matrix),
