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.
USP Reference standards 11
USP Endotoxin RS
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: Infrared Absorption 197K
Test specimen: Place 5 mL of the Assay preparation obtained as directed in the Assay, in a glass-stoppered, 100-mL volumetric flask, mix with 5 mL of Alkaline phosphatase solution prepared as directed in the Assay, and add 50 mL of methylene chloride. Insert the stopper, and allow to stand, with occasional gentle inversion (about once every 15 minutes), for 2 hours. Filter the methylene chloride layer through a dry paper, and evaporate 25 mL of the filtrate to dryness.
Standard specimen: Prepare as directed in Infrared Absorption 197K, using USP Prednisolone RS.
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 Mix 3.1 g of boric acid and 500 mL of water in a 1-L volumetric flask, add 21 mL of 1 N sodium hydroxide and 10 mL of 0.1 M magnesium chloride, dilute with water to volume, and mix.
Alkaline phosphatase solution Transfer 250 mg of alkaline phosphate enzyme to a 25-mL volumetric flask, dissolve by adding pH 9 Buffer with magnesium to volume, and mix. Prepare this solution fresh daily.
Standard preparation Dissolve a suitable, accurately weighed quantity of USP Prednisolone RS in methylene chloride, and dilute quantitatively and stepwise with methylene chloride to obtain a solution having a known concentration of about 16 µg per mL. Pipet 100 mL of the solution into a glass-stoppered, 100-mL cylinder, and add 1.0 mL of Alkaline phosphatase solution and 1.0 mL of water. Allow to stand, with occasional gentle inversion, for 2 hours.
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 Pipet 1 mL of the Assay preparation into a glass-stoppered, 100-mL cylinder, add 1.0 mL of Alkaline phosphatase solution and about 50 mL of methylene chloride, insert the stopper, and allow to stand, with occasional gentle inversion (about once every 15 minutes), for 2 hours. Add methylene chloride to volume, mix, and allow to stand until the methylene chloride layer is clear (about 20 minutes). Concomitantly and without delay, determine the absorbances of the methylene chloride solution obtained from the Assay preparation and the Standard preparation at 241 nm, with a suitable spectrophotometer, using methylene chloride as the blank. 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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USP35NF30 Page 4404