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SOP for De-aeration of Dissolution Media

Standard operating procedure to explain the De-aeration of Dissolution Media.
2024-04-17T12:30:05Z PrintOnline CoursesQuestion Forum No comments
✔ Technical Review by: | Last Verified:2024-04-17T12:30:05Z

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
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is a prominent Pharmaceutical Quality Assurance expert, consultant and the founder of Pharmaguideline. With over 22 years of hands-on experience in cGMP-compliant manufacturing environments, he specializes in establishing validation protocols, sterile area controls and data integrity systems. Ankur routinely interprets international regulatory frameworks (including FDA, EMA and ICH guidelines) to help global pharmaceutical professionals ensure strict regulatory compliance and operational excellence. Connect with Ankur on LinkedIn. Need Help: Ask Question

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