Tests for identification, quantification of impurity content, limit tests for impurity control, and quantitative analysis of the active moiety in drug substance or product samples, as well as other specific component(s), are all included in this process.
The following is a list of typical validation attributes that should be taken into account:
Precision, Specificity, Detection Limit, Quantitation Limit, Linearity, Range, and Robustness.
The kind of analytical processes will determine how the validation qualities are assessed.
Author(s) Details:
V. Siddaiah,
Department of Chemistry, Andhra University, Visakhapatnam-530003, India.
