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.

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 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.
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

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

ANNEXURE-I

QUALITY CONTROL LABORATORY

SUITABILITY TEST OF DISSOLUTION TEST APPARATUS

                                                                                                                       

CALIBRATION DATE	DATE OF LAST CALIBRATION DONE	NEXT DUE FOR CALIBRATION

INSTRUMENT DETAILS
INSTRUMENT NAME	INSTRUMENT MAKE	INSTRUMENT IDENTIFICATION NO.

OBSERVATION

        SUITABILITY TEST FOR BASKET :

1)  DISINTEGRATION TYPE CALIBRATOR

         NAME OF TABLET :    PREDNISONE 10 mg.

         LOT No.           :  

         DISSOLUTION PARAMETERS :

DISSOLUTION MEDIUM RPM TEMPERATURE TIME KETTLES

500 ml  Deaerated water 37°C +  0.5°C 30 min. Glass/ Merlon

ANNEXURE-I

QUALITY CONTROL LABORATORY

UITABILITY TEST OF DISSOLUTION TEST APPARATUS                

                                                                                                            Page 2 of 2

PREPARATION OF DEARATED WATER :

Filter the medium through 0.45 micron membrane filter and sonicate for fifteen minutes.

STANDARD PREPARATION :

Take 10 mg prednisone (previously dried at 105°C for 3 hours) in to 200 ml volumetric flask and make up the volume with dissolution medium. Dilute 10 ml of this solution to 25 ml with dissolution medium.

SAMPLE PREPARATION :

Place one tablet into each of the six bowls and operate the apparatus for 30 minutes. Draw 20 ml of sample from each bowl after 30 minutes, filter with 0.45 micron membrane filter. Discard first few ml of filtrate.

PROCEDURE :

Measure the absorbance of standard preparation and test preparation at 242 nm.

OBSERVATIONS :

Std. wt. in mg. :______________mg

Prednisone Lot No.:___________

Std. Absorbance:______________ Sample Absorbance :___________        

Balance Id.:__________________ U.V Id. No.:__________________

Reference std. No.:____________

Calculation:

 Test abs          Std. Wt. in mg

 -------------X-------------------- X 10

 Std. Abs                   1

 =  -------------X-------------------- X 10

 =------------------ % of label claim.

Sr. No.	Tablet No.		Absorbance	% of label claim	Limit
1
2
3
4
5
6
7
8
Average

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