Company Name

Procedure Number:
Page 6 of 13
Title:
Calibration of Dissolution Test Apparatus
(USP Apparatus 1 and 2)
Implementation Date:
Version Number
1.0
Contents copyrighted GMP7.com
Reproduction, photocopying, storage or transmission by magnetic or electronic means strictly prohibited. Authorization to
photocopy
items for internal or personal use is granted by GMP-Online-Consultancy. Violation of copyright will result in legal action,
including civil
and/or criminal penalties, and suspension of service.
5.3.2.2 Prednisone Standard Solution
Pipette 25 ml of Prednisone standard stock solution into a 250-ml volumetric
flask.
Dilute to volume with dissolution medium and mix thoroughly. Label Prednisone
standard solution. Prepare the standard solution on the day of use.
The chemical calibration using calibrator tablets of the disintegrating type
(Prednisone tablets, 10 mg) is carried out as described below:
5.3.2.3 Dissolution Calibration Using USP Prednisone Calibrator Tablets
Apparatus 1 (baskets)
1. Accurately transfer 500 ml of dissolution medium (de-aerated deionized
water)
to each of the six dissolution vessels.
2. Place the vessels in the constant temperature water bath, and allow the
dissolution medium to come to a temperature of 37.0 C +/- 0.5 C.
The temperature of the water must be at 37.0 C +/- 0.5 C before the
tablets
are immersed, and this temperature must be maintained throughout the
procedure.
3. Place the baskets in the dissolution medium so that there is a distance of
25
+/- 2 mm between the basket and the bottom of the vessel.
4. Place one tablet into each of the six dissolution vessels and operate the
apparatus at 100 rpm.
5. At the end of 30 minutes withdraw a 10 ml aliquot from each vessel. Filter
each aliquot immediately through a separate 0.45 m membrane filter
previously washed with 10 ml of dissolution medium. Discard the first 3 ml of
each aliquot and collect the remainder as the sample solution for the
analysis.
6. Set the wavelength range of the spectrophotometer from 200 to 400 nm.
7. Blank the spectrophotometer with dissolution medium using a 1.0 cm quartz
cell.
8. Measure the absorbance of the Prednisone standard solution and the sample
solution at the wavelength of maximum absorbance (approximately 242 nm).
9. Calculate the percent Prednisone dissolved at 30 minutes.