Prednisolone Sodium Phosphate Injection
»Prednisolone Sodium Phosphate Injection is a sterile solution of Prednisolone Sodium Phosphate in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of prednisolone phosphate (C21H29O8P),present as the disodium salt.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass,protected from light.
Identification—
A: Dissolve 65mg of phenylhydrazine hydrochloride in 100mLof dilute sulfuric acid (3in 5),add 5mLof isopropyl alcohol,and mix.Heat 5mLof this solution with 1mLof Assay preparation(obtained as directed in the Assay)at 70for 2hours:a yellow color develops.
B: It responds to Identificationtest Aunder Prednisolone Sodium Phosphate.
Bacterial endotoxins á85ñ— It contains not more than 5.0USP Endotoxin Units per mg of prednisolone phosphate.
pHá791ñ: between 7.0and 8.0.
Particulate matter á788ñ: meets the requirements under small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
pH9buffer with magnesium— Prepare as directed in the Assayunder Prednisolone Sodium Phosphate.
Alkaline phosphatase solution— Prepare as directed in the Assayunder Prednisolone Sodium Phosphate.
Standard preparation— Prepare as directed in the Assayunder Prednisolone Sodium Phosphate.
Assay preparation— Pipet a volume of Injection,equivalent to about 100mg of prednisolone phosphate,into a separator containing 20mLof water.Wash the solution with two 10-mLportions of methylene chloride,and discard the washings.Transfer the aqueous layer to a 50-mLvolumetric flask,dilute with water to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Prednisolone Sodium Phosphate.Calculate the quantity,in mg,of C21H29O8Pin each mLof the Injection taken by the formula:
6.11(C/V)(AU/AS),
in which Cis the concentration,in µg per mL,of USP Prednisolone RSin the Standard preparation,Vis the volume,in mL,of Injection taken,and AUand ASare the absorbances of the solution from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1613
Phone Number:1-301-816-8139