level: RANGE
Questions and Answers List
The following minimum specified ranges should be considered:
level questions: RANGE
| Question | Answer |
|---|---|
| for the assay of a drug substance or a finished (drug) product: | normally from 80 to 120 percent of the test concentration |
| for content uniformity | a 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 effects | the 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 used | linearity should cover the range from the reporting level of the impurities to 120% of the assay specification. |