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Factory: Gut No.402,403 Part, 434 Part, Dinkar Pada, Post-Kondala, Taluka-Wada, Dist - Thane-421312 (M.S.)

This document summarizes the calibration of a dissolution test apparatus at a pharmaceutical factory in India. It details calibrating the RPM at settings of 50, 75, and 100 and ensuring it is within ±4 RPM. It also checks the temperature calibration at 37°C every 15 minutes for 2 hours to ensure it is within ±0.5°C. The distance from the bottom of the vessel to the blade is checked to be 25mm ±2mm and the paddle or basket is checked for wobbling.

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Ravi Yadav
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109 views2 pages

Factory: Gut No.402,403 Part, 434 Part, Dinkar Pada, Post-Kondala, Taluka-Wada, Dist - Thane-421312 (M.S.)

This document summarizes the calibration of a dissolution test apparatus at a pharmaceutical factory in India. It details calibrating the RPM at settings of 50, 75, and 100 and ensuring it is within ±4 RPM. It also checks the temperature calibration at 37°C every 15 minutes for 2 hours to ensure it is within ±0.5°C. The distance from the bottom of the vessel to the blade is checked to be 25mm ±2mm and the paddle or basket is checked for wobbling.

Uploaded by

Ravi Yadav
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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Factory : Gut No.402,403 Part, 434 Part, Dinkar Pada, Post-Kondala, Taluka- Wada, Dist- Thane-421312 (M.S.

)
Tel: 02526- 211239 Telefax :02526 222429 Email : qualitynexgen_2005@hotmail.com

QUALITY CONTROL DEPARTMENT

CALIBRATION OF DISSOLUTION TEST APPARATUS


Page 1 of 2
Format No.: QC/CAL/08
Date of issue: 25/12/2007
Date of Review: Not later than Dec. 2008
Instrument: Dissolution Test Apparatus Instrument No.: QC - 21
Make: Veego Model: -
Frequency: Monthly Procedure: As per SOP No. SOP/CAL/08

Date of Calibration: _____________________

Next Calibration Due: ___________________

1. Calibration of RPM

Set RPM 50 Set RPM 75 Set RPM 100

Time in Observed RPM Time in Observed RPM Time in Observed RPM


minutes rotations minutes rotations minutes rotations

5 – 10 5 – 10 5 – 10

15 – 20 15 – 20 15 – 20

25 – 30 25 – 30 25 – 30

35 – 40 35 – 40 35 – 40

45 – 50 45 – 50 45 – 50

55 – 60 55 – 60 55 – 60

Limit of RPM within  4

Prepared by Checked by Approved by

Q. C. Chemist Q. C. Manager Q. A. Manager


Factory : Gut No.402,403 Part, 434 Part, Dinkar Pada, Post-Kondala, Taluka- Wada, Dist- Thane-421312 (M.S.)
Tel: 02526- 211239 Telefax :02526 222429 Email : qualitynexgen_2005@hotmail.com

QUALITY CONTROL DEPARTMENT

CALIBRATION OF DISSOLUTION TEST APPARATUS


Page 2 of 2
2. Calibration of temperature:

Thermometer used for calibration –

Thermometer calibrated on - Due on –

Time in minutes Set temperature Observed temperature Tolerance

0 37° C  0.5°C
15 37° C  0.5°C
30 37° C  0.5°C
60 37° C  0.5°C
90 37° C  0.5°C
120 37° C  0.5°C

When the temperature attains 37°C consider as 0 time.

3. Distance of lower edge of blade from the bottom of vessel is ________

(25mm  2mm)

4. Wobbling in paddle or basket –

Remark:

Calibrated by: Checked by:

Prepared by Checked by Approved by

Q. C. Chemist Q. C. Manager Q. A. Manager

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