SOP for Suitability Test of Dissolution Apparatus

Objective

To perform the suitability test as per U.S.P. for reliable and accurate results.

Scope

This procedure is applicable to check the suitability of the dissolution test apparatus, installed in the quality control department.

Responsibility

Doing: Technical Assistant

Checking: Executive /Manager

Accountability

Head of the Department

Procedure

• Perform the operational qualification as per SOP for Operational Qualification of Dissolution Test Apparatus.
• Use the current lot of U.S.P. standard of Prednisone and Salicylic acid tablets for calibration
• Perform the calibration using the method given by United States Pharmacopeial. Convention Inc. along with reference standards for both disintegrating type and Non disintegrating type.
• Ensure that the limit of dissolution is within the specified limit. If results far round out of the limit for RPM, Temperature, and alignment parameters, follow the SOP.

• Record all the values in the respective annexures I and II
• Frequency of calibration: every six month

1. First with a Salicylic acid tablet
2. Second with the Prednisone tablet

Abbreviations

R.P.M.= Rotation per minute

Annexure

Revision History

Nil

ALSO READ: SOP for Cleaning Procedure for Dissolution Test Apparatus