Validation characteristics according to the nature of the test.
|Type of analytical procedure characteristics||Identification||Testing for impurities||Assay dissolution
|Intermediate precision||–||+ (1)||–||+ (1)|
|Detection limit||–||− (3)||+||–|
− signifies that this characteristic is not normally evaluated; + signifies that this characteristic is normally evaluated; (1) in cases where reproducibility (see glossary) has been performed, intermediate precision is not needed ; (2) lack of specificity of one analytical procedure could be compensated by other supporting analytical procedure(s); (3) may be needed in some cases.
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