USP DISSOLUTION CALIBRATOR,

DISINTEGRATING TYPE

USP Prednisone Tablets RS

Lot O0C056

(10 mg nominal prednisone content per tablet)

This USP Dissolution Calibrator is provided for use in the Apparatus Suitability Test for

USP Apparatus 1 and 2 in the USP General Test Chapters on DISSOLUTION

and DRUG RELEASE . Do not expose the tablets to excessive humidity.

Dissolution Medium- Heat a suitable amount of water, while stirring gently, to about 41°.

Filter under vacuum through a 0.45-µm-porosity membrane into a suitable filtering flask

equipped with a stirring device. Seal the flask and continue to apply vacuum while stirring

for an additional five minutes. The temperature of the Dissolution medium does not fall

below 37° prior to the initiation of the test.

Procedure- [See DISSOLUTION and DRUG RELEASE in the current USP.]

Determine the quantity of prednisone, C21H26O5, dissolved at thirty minutes, in each vessel,

expressed as percent of the labeled amount. Use 500 mL of deaerated water as the

Dissolution medium and conduct the test at 37°. Operate each apparatus at 50- rpm speed.

Measure the amount of prednisone dissolved from filtered portions of the sample aliquots

withdrawn at thirty minutes, at the wavelength of maximum absorbance at about 242 nm in

comparison with a solution of known concentration of USP Prednisone Reference Standard.

Test Interpretation -- The apparatus is suitable if each of the individual calculated values for

each apparatus is within the specified ranges shown in the Table.

Notes: An amount of alcohol not to exceed 5% of the total volume of the standard solution

may be used to bring the prednisone standard into solution prior to dilution with Dissolution

medium. The filtering method must not cause adsorptive loss of drug. Bias introduced by

automated methods is to be avoided. If equipment is dedicated for use with only one

apparatus (basket or paddle), then the calibration is only required for that apparatus.

These values apply only to Lot O0C056

Apparatus Percentage of the labeled amount of prednisone

dissolved at 30 minutes at 50-rpm

1 53-77

2 27-48

Founded in 1820, the United States Pharmacopeial Convention comprises representatives from colleges and

national and state organizations of medicine and pharmacy. It revises and publishes The United States

Pharmacopeia and The National Formulary, the legally recognized compendia of standards for drugs.

Hi!

You can try to get it from Veego, Electrolab or Lab India. Please contact them and they will assist you with it.

Regards,

Abhishek