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  • UV-Vis (SOP)

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    nitendra pandey
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    This standard operating procedure outlines the steps for cleaning, calibrating, and operating a 6-station dissolution apparatus. The procedure defines responsibilities for executive and head quality control and describes checking water levels, filling beakers, powering on the equipment, calibrating rotation speed, temperature, timer, and performing wobble and depth tests on the paddle and basket assemblies before using the apparatus to perform dissolution tests.

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    it is a sop of uv

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    This standard operating procedure outlines the steps for cleaning, calibrating, and operating a 6-station dissolution apparatus. The procedure defines responsibilities for executive and head quality control and describes checking water levels, filling beakers, powering on the equipment, calibrating rotation speed, temperature, timer, and performing wobble and depth tests on the paddle and basket assemblies before using the apparatus to perform dissolution tests.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    13 views1 page

    UV-Vis (SOP)

    Uploaded by

    nitendra pandey
    This standard operating procedure outlines the steps for cleaning, calibrating, and operating a 6-station dissolution apparatus. The procedure defines responsibilities for executive and head quality control and describes checking water levels, filling beakers, powering on the equipment, calibrating rotation speed, temperature, timer, and performing wobble and depth tests on the paddle and basket assemblies before using the apparatus to perform dissolution tests.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    STANDARD OPERATING PROCEDURE

    1. Objective
    To define the procedure for Dissolution Test Apparatus

    2. Scope

    This procedure is applicable to clean, calibrate and operate 6- Station Dissolution


    Apparatus

    3. Responsibility
    Executive Quality Control

    4. Accountability
    Head Quality Control

    5. Procedure
    5.1. Check water level in the water bath.
    5.2. Fill water into the beakers up to the required mark.
    5.3. Switch ‘ON’ main power supply and the “Mains” of the equipment.
    5.4. Operate the equipment as per operating procedure No SPL/SOP/QC/020
    5.5. Start the Instrument and check the following parameter.
    5.6. RPM at 50 and 100. The tolerance shall be within ± 4% RPM
    5.7. Temperature water bath 37°C .The temperature shall be 36.5-37.5 °C.
    5.8. Timer 60 min. The tolerance shall be within ±1 min
    5.9. After completing the calibration and record the observation in and get it checked by QC
    Officer and approved by QC Head.
    5.10. Perform wobble test using paddle and basket assembly. The tolerance shall be ±1.0
    mm for basket and ±0.5 mm for paddle.
    5.11. Perform Depth test using paddle and basket assembly. The tolerance shall be 25 ±2.0
    mm for basket and paddle.
    5.12. Operate the equipment as per operating procedure No SPL/SOP/QC/020 and Perform
    the dissolution test on prednisone calibrator tablet.

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