Hydrocortisone Sodium Succinate
Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11)-.
Cortisol 21-(sodium succinate) [125-04-2].
» Hydrocortisone Sodium Succinate contains not less than 97.0 percent and not more than 102.0 percent of total steroids, calculated as C25H33NaO8, on the dried basis.
Packaging and storage Preserve in tight, light-resistant containers.
A: Transfer about 100 mg to a suitable container, and dissolve in about 10 mL of water. In rapid succession, add 1 mL of 3 N hydrochloric acid, shake briefly, immediately decant the aqueous layer, and wash the precipitate with two additional 10-mL portions of water, each time removing the water by decanting. Remove as much of the water as possible, spread the precipitate in a suitable container, and dry in vacuum at about 60 for 3 hours: the IR absorption spectrum of a mineral oil dispersion of the precipitate so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Hydrocortisone Hemisuccinate RS.
Solution : 20 µg per mL.
Medium : methanol.
Absorptivities at 242 nm, calculated on the dried basis, do not differ by more than 3.0%.
C: It responds to the flame test for Sodium 191.
Specific rotation 781S: between +140 and +150.
Test solution: 10 mg per mL, in alcohol.
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 2.0% of its weight.
Sodium content Dissolve, with gentle heating, about 1 g, accurately weighed, in 75 mL of glacial acetic acid. Add 20 mL of dioxane, then add crystal violet TS, and titrate with 0.1 N perchloric acid VS. Each mL of 0.1 N perchloric acid is equivalent to 2.299 mg of Na. Between 4.60% and 4.84% of Na is found, calculated on the dried basis.
Standard preparation Prepare as directed for Standard Preparation under Assay for Steroids 351, using USP Hydrocortisone Hemisuccinate RS, but dilute the solution with alcohol to a concentration of about 12.5 µg per mL.
Assay preparation Weigh accurately about 100 mg of Hydrocortisone Sodium Succinate, dissolve in sufficient alcohol to make 200.0 mL, and mix. Pipet 5 mL of this solution into a 200-mL volumetric flask, add alcohol to volume, and mix. Pipet 20 mL of the resulting solution into a glass-stoppered, 50-mL conical flask.
Procedure To each of the two flasks containing the Assay preparation and the Standard preparation, respectively, and to a similar flask containing 20.0 mL of alcohol to provide the blank, add 2.0 mL of a solution prepared by dissolving 50 mg of blue tetrazolium in 10 mL of alcohol, and mix. Then to each flask add 4.0 mL of a 1 in 10 solution of tetramethylammonium hydroxide TS in alcohol, mix, allow to stand in the dark for 90 minutes, add 1.0 mL of glacial acetic acid, mix, and proceed as directed for Procedure under Assay for Steroids 351, beginning with Concomitantly determine the absorbances. Calculate the quantity, in mg, of C25H33NaO8 in the Hydrocortisone Sodium Succinate taken by the formula:
8.38C(AU / AS).
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USP32NF27 Page 2583