SOP for Deaeration of Dissolution Media

OBJECTIVE

To lay down the procedure for the Deaeration of dissolution media.

SCOPE

This procedure is applicable to the dissolution method, which specifies the use of Deaerated dissolution medium.

RESPONSIBILITY

Doing: Technical Assistant

Checking: Executive/Manager

ACCOUNTABILITY

Head of the Department

PROCEDURE

• Heat the required volume of Dissolution medium at about 41°C with gentle stirring.
• 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.
• Seal the flask with Aluminium foil and continue to apply a vacuum with stirring for an additional five minutes.
• Immediately transfer the medium directly to the dissolution bowl.
• Take precautions to prevent air interruption in the medium.

ANNEXURE

Nil

REVISION HISTORY

Nil

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