SOP for Check Suitability of Dissolution Test Apparatus
1.0 OBJECTIVE
To perform the suitability test as per U.S.P. for reliable and accurate results.
2.0 SCOPE
This procedure is applicable to check suitability of dissolution test apparatus, installed in quality control department.
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3.0 RESPONSIBILITY
3.1 Doing: Technical Assistant
3.2 Checking: Executive /Manager
4.0 ACCOUNTABILITY
Head of the Department
5.0 PROCEDURE
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5.1 Perform the operational qualification as per reference S.O.P.
5.2 Use current lot of U.S.P. standard of Prednisone and Salicylic acid tablets for calibration
5.3 Perform the calibration as per the method given by United States Pharmacopeial Convention Inc. along with reference standard for both disintegrating type and Non disintegrating type.
5.4 Ensure that the limits of dissolution are within the specified limit.
5.5 If results found out of limit for RPM, Temperature and alignment parameters, follow the S.O.P. for parameters.
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5.6 Record all the values in the respective annexure I and II.
5.7 Frequency of calibration :- every six month
1. First with Salicylic acid tablet
2. Second with Prednisone tablet
6.0 ABBREVIATIONS
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6.1 R.P.M.= Rotation per minute
6.2 ml= milliliter
6.3 min.= Minute
6.4 °C= Degree centigrade
6.5 mg= milligram
6.6 %= Percentage
6.7 & = and
