Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus

Importancia y uso:

2.1 This practice outlines a procedure for the mechanical calibration of paddle and basket dissolution units to ensure reproducibility of results.

2.2 Once a unit meets all of the mechanical specifications included in this practice, it is considered calibrated and further calibration with dissolution calibrator tablets is not required.

Subcomité:

E55.12

Volúmen:

14.01

Número ICS:

11.120.99 (Other standards related to pharmaceutics)

Palabras clave:

basket dissolution apparatus; calibration; paddle dissolution apparatus;