Prednisolone Sodium Succinate for Injection
Pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11)-.
11,17,21-Trihydroxypregna-1,4-diene-3,20-dione 21-(sodium succinate) [1715-33-9].
» Prednisolone Sodium Succinate for Injection is sterile prednisolone sodium succinate prepared from Prednisolone Hemisuccinate with the aid of Sodium Hydroxide or Sodium Carbonate. It contains the equivalent of not less than 90.0 percent and not more than 110.0 percent of the labeled amount of prednisolone (C21H28O5). It contains suitable buffers.
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
USP Reference standards 11
USP Endotoxin RS
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Identification Place about 50 mg in a separator, add 20 mL of water and 2 mL of 3 N hydrochloric acid, and extract with 25 mL of chloroform. Filter the extract into a suitable beaker, evaporate on a steam bath to dryness, and dry the residue at 60 for 1 hour: the residue so obtained responds to Identification test A under Prednisolone Hemisuccinate.
Bacterial endotoxins 85 It contains not more than 5.8 USP Endotoxin Units per mg of prednisolone.
pH 791: between 6.7 and 8.0, determined in the solution constituted as directed in the labeling.
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 2.0% of its weight.
Particulate matter 788: meets the requirements under small-volume injections.
Other requirements It meets the requirements for Sterility Tests 71, Uniformity of Dosage Units 905 and Labeling under Injections 1.
Standard preparation Dissolve about 64 mg of USP Prednisolone Hemisuccinate RS, accurately weighed, in about 100 mL of alcohol, add 5.0 mL of water, dilute with alcohol to 200.0 mL, and mix. Dilute 4.0 mL of this solution with alcohol to 100.0 mL, and mix. Pipet 20 mL of the resulting solution into a glass-stoppered, 50-mL conical flask.
Assay preparation Transfer an accurately weighed portion of Prednisolone Sodium Succinate for Injection, equivalent to about 50 mg of prednisolone, to a 200-mL volumetric flask, dissolve in 5.0 mL of water, add alcohol to volume, and mix. Dilute 4.0 mL of this mixture with alcohol to 100.0 mL, and mix. Pipet 20 mL of the resulting solution into a glass-stoppered, 50-mL conical flask.
Procedure Proceed as directed under Assay for Steroids 351. Calculate the quantity, in mg, of C21H28O5 in the portion of Prednisolone Sodium Succinate for Injection taken by the formula:
5C(0.7827)(AU / AS)in which C is the concentration, in µg per mL, of USP Prednisolone Hemisuccinate RS in the Standard preparation, 0.7827 is the ratio of the molecular weight of prednisolone to that of prednisolone hemisuccinate, and AU and AS are the absorbances of the solutions from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 4405