Analytical Method Development by LCMS in India & 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 Method Development by LCMS in India.
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),
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