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Salom Pharmacy LTD: Quality Control Laboratory SPL-SOP-QC-DISS-001 Operation of Dissolution Rate Apparatus

This document provides the standard operating procedure for operating a Dissolution Rate Apparatus in the Quality Control laboratory of Salom Pharmacy Ltd. It outlines the responsibilities of analysts and managers, the frequency of use of the apparatus, and the step-by-step procedure for preparing buffers, calibrating temperature, introducing samples, and analyzing drawn samples. The documentation requirements and abbreviations are also specified.

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583 views2 pages

Salom Pharmacy LTD: Quality Control Laboratory SPL-SOP-QC-DISS-001 Operation of Dissolution Rate Apparatus

This document provides the standard operating procedure for operating a Dissolution Rate Apparatus in the Quality Control laboratory of Salom Pharmacy Ltd. It outlines the responsibilities of analysts and managers, the frequency of use of the apparatus, and the step-by-step procedure for preparing buffers, calibrating temperature, introducing samples, and analyzing drawn samples. The documentation requirements and abbreviations are also specified.

Uploaded by

Paolo Peps
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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SALOM PHARMACY LTD

PLOT 7 BLK 1 ASOKORE-MAMPONG INDUSTRIAL AREA, KUMASI


STANDARD OPERATING PROCEDURE
Department: QUALITY CONTROL LABORATORY
SOP Number: SPL-SOP-QC-DISS-001
SOP Title: OPERATION OF DISSOLUTION RATE APPARATUS
Effective date: November, 2016 Review date: November, 2018 Page: 1 of 2
Revision No: 11/16 Supersedes No: NIL

1.0 PURPOSE: To lay down a procedure for the operation of Dissolution Rate Apparatus.

2.0 SCOPE: This procedure is applicable to Dissolution Rate Apparatus used in the QC lab.

3.0 RESPONSIBILITIES:
 Analyst(s) – shall be responsible to undertake the procedure.
 Quality Control Manager – shall ensure that the procedure is followed accurately.

4.0 FREQUENCY OF USE: As and when the dissolution of tablets and capsules is to be determined.

5.0 DEFINITION:

Dissolution Rate Apparatus – It is used to provide critical in vitro drug release information for both quality
control purposes i.e. to assess batch to batch consistency of solid oral dosage forms such as tablets, capsules,
boluses pessaries, suppositories and drug development, i.e. to predict in vivo drug release profiles.

6.0 PROCEDURE
 Prepare a buffer at a required pH using six litres of demineralized water for dissolution.
 Switch the apparatus on from the mains and also turn “ON” circulation pump
 Wait till the front panel indicates “TURN ON” heater, before switching on the heater
 Fill each of the cylindrical vessel to the 900ml mark with the prepared buffer and place in the vessel
according to their appropriate numbers
 Keep the probe in the vessel container to prevent over-heating and the other in the cylindrical vessel to
determine the temperature
 Wait and check till the temperature of each vessel reaches 37oC
 At 37oC, drop the tablet or capsule gently via the wall of the cylindrical vessel until it settle at the bottom
of the cylinder
 Place the paddle(for Tablets) or basket(for capsules) in the shaft and lower the shaft gently using the
knob on the panel into the cylindrical cap, turn “ON” the stirrer
 Wait after completion of the test time, draw with syringe to begin analysis.

7.0 RECORDS: Equipment Log sheet.

8.0 REFERENCE DOCUMENTS: Equipment Logbook.

7.0 ABBREVIATIONS
SOP – Standard Operating Procedure
QC – Quality Control
DTA – Dissolution Rate Apparatus
SALOM PHARMACY LTD
PLOT 7 BLK 1 ASOKORE-MAMPONG INDUSTRIAL AREA, KUMASI
STANDARD OPERATING PROCEDURE
Department: QUALITY CONTROL LABORATORY
SOP Number: SPL-SOP-QC-DTA-001
SOP Title: Operation of Disintegration Test Apparatus
Effective date: November, 2016 Review date: November, 2018 Page: 2 of 3
Revision No: 10/16 Supersedes No: NIL

Prepared by Checked by Approved by


Name: Derrick Intarmah A. Agyenim-Boateng Emmanuel Orman
Signature:

Date:
Department: Quality Control Quality Control Quality Assurance

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