SOP for De-aeration of Dissolution Media

1.0 OBJECTIVE

To lay down the procedure for De-aeration of Dissolution media.

2.0 SCOPE

This procedure is applicable to dissolution method which specifies the use of De-aerated dissolution medium.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant
3.2 Checking: Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Heat the required volume of dissolution medium at about 41°C with gentle stirring.
5.1 Immediately filter the medium with constant stirring under vacuum using a filter, having a porosity of 0.45 micron or less into a suitable filtering flask, equipped with a stirring device.
5.2 Seal the flask with Aluminium foil and continue to apply a vacuum with stirring for an additional five minutes.
5.4 Immediately transfer the medium directly to the dissolution bowl.
5.5 Take precaution to prevent air interruption in the medium.

Related: Tablet Dissolution Test in Different Stages (S1, S2 and S3)

6.0 ABBREVIATIONS

6.1 °C = Degree centigrade

Get editable documentsView List