|
Dienestrol
(dye'' en es' trol).
Phenol, 4,4¢-(1,2-diethylidene-1,2-ethanediyl)bis-, (E,E)-. (E,E)-4,4¢-(Diethylideneethylene)diphenol » Dienestrol contains not less than 98.0 percent and not more than 100.5 percent of C18H18O2, calculated on the dried basis.
Packaging and storage
Preserve in well-closed containers.
Identification
B:
Ultraviolet Absorption
Solution:
5 µg per mL.
Medium:
alcohol.
Absorptivities at 228 nm, calculated on the dried basis, do not differ by more than 3.0%.
C:
To a solution of about 10 mg in 0.5 mL of alcohol add 1 mL of hydrochloric acid and about 50 mg of vanillin: a blue color is produced immediately, and it persists on dilution with water but disappears on the addition of alkali (distinction from diethylstilbestrol, which produces no color).
Melting range
Loss on drying
Residue on ignition
Assay
Mobile phase, Internal standard solution, and Standard preparation
Prepare as directed in the Assay under Dienestrol Cream.
Assay preparation
Transfer about 25 mg of Dienestrol, accurately weighed, to a 100-mL volumetric flask. Add methanol to volume, and mix. Pipet 2 mL of this solution, 5 mL of Internal standard solution, and 5 mL of water into a 50-mL volumetric flask. Dilute with methanol to volume, and mix.
Procedure
Proceed as directed for Procedure in the Assay under Dienestrol Cream. Calculate the quantity, in mg, of C18H18O2 in the portion of Dienestrol taken by the formula:
2.5C(RU / RS).
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2891
|