Method Development by LCMS in India
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),
ICH Q2 R1: OBJECTIVE Validation of analytical techniques The goal of validating an analytical technique is to show that it is appropriate for the intended use. The properties pertinent to impurity control, test techniques, and identification are summarised in a table.
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