Prednisolone Tebutate
Pregna-1,4-diene-3,20-dione, 11,17-dihydroxy-21-(3,3-dimethyl-1-oxobutyl)oxy-, (11 ![]() 11 ![]() ![]() ![]() ![]() » Prednisolone Tebutate contains not less than 97.0 percent and not more than 103.0 percent of C27H38O6, calculated on the dried basis.
Packaging and storage
Preserve in tight containers sealed under sterile nitrogen, in a cold place.
Identification
A:
Dissolve a portion of it in acetone, and evaporate to dryness: the IR absorption spectrum of a mineral oil dispersion of the residue so obtained, previously dried at a pressure not exceeding 5 mm of mercury at 105
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B:
Ultraviolet Absorption
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Solution:
20 µg per mL.
Medium:
methanol.
Absorptivities at 242 nm, calculated on the dried basis, do not differ by more than 3.0%.
Loss on drying
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Residue on ignition
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Selenium
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Assay
Mobile solvent
Prepare a mixture of isooctane, tetrahydrofuran, and alcohol (89:10:1).
Standard preparation
Dissolve a suitable quantity of USP Prednisolone Tebutate RS, accurately weighed, in a mixture of tetrahydrofuran and isooctane (1:1) to obtain a solution having a known concentration of about 1 mg per mL.
Assay preparation
Weigh accurately about 50 mg of Prednisolone Tebutate, transfer to a 50-mL volumetric flask, dilute with tetrahydrofuran and isooctane (1:1) to volume, and mix.
Procedure
Inject separately 25-µL volumes of the Standard preparation and the Assay preparation into a suitable high-pressure liquid chromatograph equipped with a constant flow pump and a 30-cm × 3.9-mm column that contains packing L3, is operated at 25
![]() 50C(RU / RS)
in which C is the concentration, in mg per mL, of USP Prednisolone Tebutate RS in the Standard preparation, and RU and RS are the peak areas obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 3375
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