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 90.0 percent and not more than 110.0 percent 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 I glass, protected from light.
A: Dissolve 65 mg of phenylhydrazine hydrochloride in 100 mL of dilute sulfuric acid (3 in 5), add 5 mL of isopropyl alcohol, and mix. Heat 5 mL of this solution with 1 mL of Assay preparation (obtained as directed in the Assay) at 70 for 2 hours: a yellow color develops.
Bacterial endotoxins 85 It contains not more than 5.0 USP Endotoxin Units per mg of prednisolone phosphate.
pH 791: between 7.0 and 8.0.
Particulate matter 788: meets the requirements under small-volume injections.
Other requirements It meets the requirements under Injections 1.
Alkaline phosphatase solution Prepare as directed in the Assay under Prednisolone Sodium Phosphate.
Assay preparation Pipet a volume of Injection, equivalent to about 100 mg of prednisolone phosphate, into a separator containing 20 mL of water. Wash the solution with two 10-mL portions of methylene chloride, and discard the washings. Transfer the aqueous layer to a 50-mL volumetric flask, dilute with water to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Prednisolone Sodium Phosphate. Calculate the quantity, in mg, of C21H29O8P in each mL of the Injection taken by the formula:
6.11(C / V)(AU / AS)in which C is the concentration, in µg per mL, of USP Prednisolone RS in the Standard preparation, V is the volume, in mL, of Injection taken, and AU and AS are the absorbances of the solution from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 3374