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level: RANGE

Questions and Answers List

The following minimum specified ranges should be considered:

level questions: RANGE

QuestionAnswer
for the assay of a drug substance or a finished (drug) product:normally from 80 to 120 percent of the test concentration
for content uniformitya minimum of 70 to 130 percent of the test concentration, unless a wider more appropriate range, based on the nature of the dosage form (e.g., metered dose inhalers), is justified
for dissolution testing:+/-20 % over the specified range
For the determination of an impurity:from the reporting level of an impurity to 120% of the specification
for impurities known to be unusually potent or to produce toxic or unexpected pharmacological effectsthe detection/quantitation limit should be COMMENSURATE with the level at which the impurities must be controlled
if assay and purity are performed together as one test and only a 100% standard is usedlinearity should cover the range from the reporting level of the impurities to 120% of the assay specification.