Desoxycorticosterone Pivalate Injectable Suspension
»Desoxycorticosterone Pivalate Injectable Suspension is a sterile suspension of Desoxycorticosterone Pivalate in an aqueous medium.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C26H38O4.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass,protected from light.
Labeling— Label Suspension to indicate that it is for veterinary use only.
Identification— Centrifuge a portion of Suspension,decant the supernatant,wash the residue by stirring with several successive portions of water,centrifuging and decanting each time,and finally dry the residue at 105:the desoxycorticosterone pivalate so obtained melts between 198and 204,and when about 5mg of the residue is dissolved in 2mLof sulfuric acid,the solution is yellowish,with a greenish fluorescence.Dilute the solution with 2mLof water:the color changes to a dark red-blue,and on further dilution with 2mLof water it is discharged.
Bacterial endotoxins á85ñ— It contains not more than 2.78USP Endotoxin Units per mg of desoxycorticosterone pivalate.
pHá791ñ: between 5.0and 7.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Desoxycorticosterone Pivalate.
Assay preparation— Using a “to contain”pipet,transfer an accurately measured volume of Suspension,equivalent to about 125mg of desoxycorticosterone pivalate,to a 250-mLvolumetric flask.Add about 200mLof methanol,and sonicate to dissolve.Add 25.0mLof the Internal standard solution,dilute with methanol to volume,and mix.Centrifuge a 20-mLportion at high speed for about 5minutes.Filter the supernatant through a 5-µm disk,discarding the first 5mLof the filtrate.
Procedure— Proceed as directed for Procedurein the Assayunder Desoxycorticosterone Pivalate.Calculate the quantity,in mg,of C26H38O4in each mLof the Suspension taken by the formula:
250(C/V)(RU/RS),
in which Vis the volume,in mL,of Suspension taken,and the other terms are as previously defined.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 587
Phone Number:1-301-816-8178