Table III.
Similarities and Differences in the Minimum Number of Time Points Required for an f 2 Calculation
| Country | Minimum number of time points |
|---|---|
| China (20) | A minimum of three time points (zero excluded) until drugs undergo more than 90% dissolution or reaches dissolution platform. |
| Europe (5), Australia (17), Russia (5), Turkey (27) | A minimum of three time points (zero excluded). |
| South Africa (28), Thailand (26), United States (14) | A minimum of three time points. |
| India (21) | Suitably spaced time points to provide a profile for each batch (e.g., 10, 20, 30 min) to achieve virtually complete dissolution. |
| Canada (19) | Adequate sampling should be performed until either 90% of drug from the drug product is dissolved or an asymptote is reached. |
| Mexico (25) | At least five sampling points. Only two points will be on the plateau of the curve and the other three will be distributed between the ascending stage and the inflection stage. |
| Brazil (18) | A minimum of five time points (zero excluded). |
| Japan (6,23,24) |
•% Dissolution ≥85% in 15–30 min: three time points. •% Dissolution is ≥85% at 120 min in pH 1.2 and 360 min in other media: four time points. •% Dissolution is 50–85% between 30 and 120 min in pH 1.2 and 30–360 min in other media: eight time points. •% Disso <50% between 30 and 120 min in pH 1.2 and 30–360 min in other media: eight time points. |
| South Korea (29) |
•If the mean dissolution rate of reference drug is NLT 85% within 15 ~ 30 min: 15, 30, 45 min (three time points). •If the mean dissolution rate of reference drug is not less than 85% after 30 min but within specified test time: Ta/4, 2Ta/4, 3Ta/4. Ta, where Ta is the time point when the mean dissolution rate of reference drug is approx 85%. •If the mean dissolution rate of reference drug is less than 85% within the specified test time: Ta/4, 2Ta/4, 3Ta/4. Ta, where Ta is the time point when the mean dissolution rate of reference drug is approx 85% with the test time. |