Packaging and storage—
Preserve in tight containers.
Labeling—
Label the Tablets to indicate that they are intended for veterinary use only.
Uniformity of dosage units á905ñ:
meet the requirements for
Weight Variationwith respect to tetracycline hydrochloride and to novobiocin sodium and for
Content Uniformitywith respect to prednisolone.
Procedure for content uniformity for prednisolone—
Mobile phase
,
Internal standard solution,and
Chromatographic system—Prepare as directed in the
Assayunder
Prednisolone.
Test preparation—
Transfer 1Tablet to a suitable container,add 7mLof diluted methanol (2in 7)for each 1.5mg of prednisolone in the Tablet,based on the labeled amount,and allow to stand for 90minutes,occasionally agitating gently to ensure that the Tablet disintegrates.For each 1.5mg of prednisolone,add 3.0mLof Internal standard solution,12mLof water-saturated chloroform,and about 10glass beads.Securely close the container,and shake by mechanical means for 30minutes.Carefully open the container,add 0.5mLof sodium carbonate solution (1in 4),reclose the container,and shake by mechanical means for 5minutes.Centrifuge,remove the upper layer by aspiration,discarding the aspirated liquid,and retain the clear chloroform layer (Test preparation).
Procedure—
Proceed as directed for
Procedurein the
Assayunder
Prednisolone.Calculate the quantity,in mg,of prednisolone (C
21H
28O
5)in the Tablet taken by the formula:
0.015C(RU/RS),
in which the terms are as defined therein.
Limit of 4-epianhydrotetracycline á226ñ—
To an accurately weighed quantity of finely powdered Tablets,equivalent to about 250mg of tetracycline hydrochloride,add 10mLof 0.1Nhydrochloric acid,and adjust with 6Nammonium hydroxide to a pHof 7.8.Transfer this solution with the aid of
EDTA Bufferto a 50-mLvolumetric flask,dilute with
EDTA Bufferto volume,and mix.Use this solution,without delay,as the
Test Solution:not more than 2.0%is found.
Assay for prednisolone—
Mobile phase
,
Internal standard solution,and
Chromatographic system—Prepare as directed in the
Assayunder
Prednisolone.
Standard preparation—
Transfer about 10mg of
USP Prednisolone RS,accurately weighed,to a 100-mLvolumetric flask,add 20.0mLof
Internal standard solution,and swirl to dissolve.Dilute with water-saturated chloroform to volume,and mix.Transfer 15.0mLof this solution to a suitable container,add 7mLof diluted methanol (2in 7),securely close the container,and shake by mechanical means for 30minutes.Carefully open the container,add 0.5mLof sodium carbonate solution (1in 4),reclose the container,and shake by mechanical means for 5minutes.Centrifuge,remove the upper layer by aspiration,discarding the aspirated liquid,and retain the clear chloroform layer (
Standard preparation).
Assay preparation—
Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 1.5mg of prednisolone,to a suitable container containing about 10glass beads.Add 3.0mLof Internal standard solution,12mLof water-saturated chloroform,and 7mLof diluted methanol (2in 7),securely close the container,and shake by mechanical means for 30minutes.Carefully open the container,add 0.5mLof sodium carbonate solution (1in 4),reclose the container,and shake by mechanical means for 5minutes.Centrifuge,remove the upper layer by aspiration,discarding the aspirated liquid,and retain the clear chloroform layer (Assay preparation).
Procedure—
Proceed as directed for
Procedurein the
Assayunder
Prednisolone.Calculate the quantity,in mg,of prednisolone (C
21H
28O
5)in the portion of Tablets taken by the formula:
0.015C(RU/RS),
in which the terms are as defined therein.