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.
B: It responds to Identification test A under Prednisolone Sodium Phosphate.
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.
pH 9 buffer with magnesium— Prepare as directed in the Assay under Prednisolone Sodium Phosphate.
Alkaline phosphatase solution— Prepare as directed in the Assay under Prednisolone Sodium Phosphate.
Standard preparation— 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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3374