There has been increased regulatory scrutiny on validation of analytical methods. PSC can assist you in the validation of analytical methods to meet ICH standards. We can also support you in the validation of test methods required for your stability studies and cleaning validation studies. Our experts will help you identify the relevant validation requirements.
For example, only specificity is needed for an identification test, however, the full range of specificity, accuracy, linearity, range, limit of detection (LOD), limit of quantitation (LOQ), precision, and robustness testing may be needed for more-complex methods such as quantitative impurity testing.
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