Phenylbutazone Injection
»Phenylbutazone Injection is a sterile solution of Phenylbutazone in Sterile Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C19H20N2O2.
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass.Protect from light,and store in a refrigerator.
Labeling— Label Injection to indicate that it is for veterinary use only.
Clarity of solution— The Injection is essentially free from particles of foreign matter that can be observed on visual inspection.
Identification—
A: Transfer a volume of Injection,equivalent to about 500mg of phenylbutazone,to a 250-mLconical flask,add 100mLof solvent hexane,and heat the mixture under reflux for 15minutes.Filter the hot mixture,and allow the filtrate to cool.Separate the crystals thus formed by filtration,and dry in vacuum at 80for 30minutes:the phenylbutazone so obtained responds to Identificationtest Aunder Phenylbutazone.
B: The retention time of the phenylbutazone peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparationas obtained in the Assay.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtration underTest for Sterility of the Product to be Examined.
Bacterial endotoxins á85ñ— It contains not more than 1.1USP Endotoxin Units per mg of phenylbutazone.
pHá791ñ: between 9.5and 10.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Acetate buffer,Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Phenylbutazone.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 200mg of phenylbutazone,to a 100-mLvolumetric flask.Dilute with acetonitrile to volume,and mix.Transfer 7.0mLof this solution to a 50-mLvolumetric flask,add 10.0mLof Internal standard solution,dilute with acetonitrile to volume,and mix.[NOTE—Use this solution within 8hours of its preparation.]
Procedure— Proceed as directed for Procedurein the Assayunder Phenylbutazone.Calculate the quantity,in mg,of C19H20N2O2in each mLof the Injection taken by the formula:
350(C/V)(RU/RS),
in which Cis the concentration,in mg per mL,of USP Phenylbutazone RSin the Standard preparation,Vis the volume,in mL,of Injection taken to prepare the Assay preparation,and RUand RSare the ratios of the peak responses of phenylbutazone to that of the internal standard 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 1540
Pharmacopeial Forum:Volume No.29(6)Page 1964
Phone Number:1-301-816-8178