Prednisone Injectable Suspension
»Prednisone Injectable Suspension is a sterile suspension of Prednisone in a suitable aqueous medium.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C21H26O5.
Packaging and storage— Preserve in multiple-dose containers,preferably of Type Iglass.
Labeling— Label it to indicate that it is for veterinary use only.Label it to indicate that it is for intramuscular administration only.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparation,both relative to the internal standard,as obtained in the Assay.
pHá791ñ: between 3.0and 7.0.
Sterility á71ñ— It meets the requirements when tested as directed for Direct Inoculation of the Culture Medium under Test for Sterility of the Product to be Examined.
Bacterial endotoxins á85ñ— It contains not more than 2.27Endotoxin Units per mg of prednisone.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase— Prepare a filtered and degassed mixture of methanol and 0.05Mmonobasic potassium phosphate (350:300).Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Internal standard solution— Dissolve a quantity of betamethasone in methanol to obtain a solution containing about 0.4mg per mL.
Standard preparation— Dissolve an accurately weighed quantity of USP Prednisone RSin methanol,and dilute quantitatively,and stepwise if necessary,with methanol to obtain a solution having a known concentration of about 0.25mg per mL.Transfer 10.0mLof this solution to a 50-mLvolumetric flask.Add 10.0mLof Internal standard solution,dilute with methanol to volume,and mix.
Assay preparation— Transfer an accurately measured volume of well-mixed Suspension,equivalent to about 80mg of prednisone,to a 100-mLvolumetric flask.Dilute with methanol to volume,and mix.Transfer 3.0mLof this solution to a 50-mLvolumetric flask.Add 10.0mLof Internal standard solution,dilute with methanol to volume,and mix.
Chromatographic system (see Chromatography á621ñ)—The liquid chromatograph is equipped with a 254-nm detector and a 4-mm ×30-cm column that contains packing L1.The flow rate is about 1mLper minute.Chromatograph the Standard preparation,and record the peak responses as directed for Procedure:the relative retention times are about 1.9for betamethasone and 1.0for prednisone,the resolution,R,between the prednisone peak and the betamethasone peak is not less than 3.5,and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the analyte peaks.Calculate the quantity,in mg,of prednisone in each mLof the Suspension taken by the formula:
5000(C/3V)(RU/RS),
in which Cis the concentration,in mg per mL,of USP Prednisone RSin the Standard preparation,Vis the volume,in mL,of the Suspension taken to prepare the Assay preparation,and RUand RSare the ratios of the prednisone peak to the internal standard peak obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 1616
Phone Number:1-301-816-8178