(pred nis' oh lone hem'' ee sux' i nate).
Pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, (11)-.
11,17,21-Trihydroxypregna-1,4-diene-3,20-dione 21-(hydrogen succinate) [2920-86-7].
»Prednisolone Hemisuccinate contains not less than 98.0 percent and not more than 102.0 percent of C25H32O8, calculated on the dried basis.
Packaging and storage Preserve in tight containers.
USP Reference standards 11
B: Ultraviolet Absorption 197U
Solution: 20 µg per mL.
Absorptivities at 243 nm, calculated on the dried basis, do not differ by more than 3.0%.
Specific rotation 781S: between +99 and +104.
Test solution: 6.7 mg per mL, in dioxane.
Loss on drying 731 Dry it in vacuum at 65 for 3 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: negligible, from 100 mg.
Standard preparation Dissolve an accurately weighed quantity of USP Prednisolone Hemisuccinate RS in a mixture of equal volumes of alcohol and chloroform to obtain a solution having a known concentration of about 8 mg per mL.
Assay preparation Weigh accurately about 80 mg of Prednisolone Hemisuccinate, previously dried, dissolve in a mixture of equal volumes of alcohol and chloroform to make 10.0 mL, and mix.
Procedure Use a 20- × 20-cm chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture, which has been activated by heating at 105 for 1 hour. Using a solvent system consisting of a mixture of 5 parts of butyl alcohol, 4 parts of acetic acid, and 1 part of water, proceed as directed for Procedure under Single-steroid Assay 511, ending with Centrifuge the tubes for 5 minutes, except to apply 50 µL in place of 200 µL of the solutions to the plate. Concomitantly determine the absorbances of the solutions in 1-cm cells at the wavelength of maximum absorbance at about 243 nm, with a suitable spectrophotometer, against the blank. Calculate the quantity, in mg, of C25H32O8 in the portion of Prednisolone Hemisuccinate taken by the formula:
10C(AU / AS)in which C is the concentration, in mg per mL, of USP Prednisolone Hemisuccinate RS in the Standard preparation, 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 4402