METHOD VALIDATION EXPERIMENTS
In this section we outline the requirements for method validation according to
current ICH guidelines.
Specificity
ICH definition: Specificity is the ability to assess unequivocally the analyte in the
presence of components that may be expected to be present.
Most related substance methods will be used in a stability study, and therefore
they have to be stability indicating. Stability indicatingmeans that the method
has sufficient specificity to resolve all related substances and the drug substance
from each other. Typically, for the related substance method for a drug product,
degradation products are the most critical related substances. Therefore, as a
minimum requirement, the method should have sufficient specificity to resolve
the degradation products and the drug substance. In addition, all degradation
products should be resolved from potential interference with the excipients. |
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