Determination of release limits: a general methodology

Release limits of drug dosage forms are defined as the bounds on the potency at which an individual lot can be released for marketing which will ensure that it remains within registered limits throughout its shelf life. A statistically based method is described for calculating release limits for any type of dosage form and any parameter for which the rate of change with time is predictably uniform and linear. When the mean release assay result for a specific product lot is at or within the calculated release limit bounds, assurance is provided at the specified confidence level that the average assay results obtained at any subsequent time within the shelf life will remain within registered limits.