When performing the test of Dissolution Profile Comparisons, the followings should be applied:
1. An appropriate reference product needs to be selected based on the purpose of the studies. The formulation, manufacturing, and quality data of test product should be available.
2. Dissolution profile comparisons of test products and reference products should be carried out under the same and adequate test conditions. An aqueous medium at 37 ℃ and with pH values to mimic gastrointestinal conditions or at least three aqueous medium simulating gastrointestinal conditions (with pH range 1.2 to 6.8) should be carried out in dissolution testing.
The adequate test conditions mentioned in the preceding paragraph can be, for example, the basket method, the agitation is 50-100 rpm; the paddle method is 50-75 rpm; or other apparatus and agitation specified in the Pharmacopeia.Under certain circumstances dissolution be tested in other conditions, scientific evidences shall be provided and reviewed by the central competent health authority.

Instruments and analytical methods used for dissolution profile comparison shall be documented for system suitability and analytical methods validation, respectively.

When dissolution profile comparisons is used to waive bioequivalence requirements, the number of test drugs and reference drug in dissolution profile comparison shall be at least 12 dosage units each with sufficient sampling points. The values of similarity factor (f2 value) or other appropriate statistical results should be provided.
The percent of variation coefficient of test and reference products at the first sample point should not be more than 20%, and at other time points should not be more than 10%.
Only one measurement should be considered after 85% dissolution of both the products in f2 value calculation. If more than 85% of the drug is dissolved within 15 minutes, dissolution profiles may be accepted as similar without further mathematical evaluation.
The method to calculate dissolution similarity and result interpretation are provided in the attachment.