Hydrocortisone Sodium Succinate
C25H33NaO8
484.51
Pregn-4-ene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-,monosodium salt,(11b)-.
Cortisol 21-(sodium succinate) [125-04-2].
»Hydrocortisone Sodium Succinate contains not less than 97.0percent and not more than 102.0percent of total steroids,calculated as C25H33NaO8,on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
Identification—
A:
Transfer about 100mg to a suitable container,and dissolve in about 10mLof water.In rapid succession,add 1mLof 3Nhydrochloric acid,shake briefly,immediately decant the aqueous layer,and wash the precipitate with two additional 10-mLportions 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 3hours:the IRabsorption 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.
for 3hours:the IRabsorption 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
:20µg per mL.
Medium
:methanol.
Absorptivities at 242nm,calculated on the dried basis,do not differ by more than 3.0%.
C:
It responds to the flame test for Sodium á191ñ.
Specific rotation á781Sñ:
between +140and +150.
and +150.
Test solution:
10mg per mL,in alcohol.
Loss on drying á731ñ—
Dry it at 105for 3hours:it loses not more than 2.0%of its weight.
for 3hours:it loses not more than 2.0%of its weight.
Sodium content—
Dissolve,with gentle heating,about 1g,accurately weighed,in 75mLof glacial acetic acid.Add 20mLof dioxane,then add crystal violet TS,and titrate with 0.1Nperchloric acid VS.Each mLof 0.1Nperchloric acid is equivalent to 2.299mg of Na.Between 4.60%and 4.84%of Na is found,calculated on the dried basis.
Assay—
Standard preparation—
Prepare as directed for Standard Preparationunder Assay for Steroids á351ñ,using USP Hydrocortisone Hemisuccinate RS,but dilute the solution with alcohol to a concentration of about 12.5µg per mL.
Assay preparation—
Weigh accurately about 100mg of Hydrocortisone Sodium Succinate,dissolve in sufficient alcohol to make 200.0mL,and mix.Pipet 5mLof this solution into a 200-mLvolumetric flask,add alcohol to volume,and mix.Pipet 20mLof the resulting solution into a glass-stoppered,50-mLconical flask.
Procedure—
To each of the two flasks containing the Assay preparationand the Standard preparation,respectively,and to a similar flask containing 20.0mLof alcohol to provide the blank,add 2.0mLof a solution prepared by dissolving 50mg of blue tetrazolium in 10mLof alcohol,and mix.Then to each flask add 4.0mLof a 1in 10solution of tetramethylammonium hydroxide TSin alcohol,mix,allow to stand in the dark for 90minutes,add 1.0mLof glacial acetic acid,mix,and proceed as directed for Procedureunder Assay for Steroids á351ñ,beginning with “Concomitantly determine the absorbances.”Calculate the quantity,in mg,of C25H33NaO8in the Hydrocortisone Sodium Succinate taken by the formula:
8.38C(AU/AS).
Auxiliary Information—
Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 968
Phone Number:1-301-816-8139