Dienestrol
;)
Phenol,4,4¢-(1,2-diethylidene-1,2-ethanediyl)bis-,(E,E)-.
(E,E)-4,4¢-(Diethylideneethylene)diphenol [84-17-3;13029-44-2].
»Dienestrol contains not less than 98.0percent and not more than 100.5percent of C18H18O2,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Ultraviolet Absorption á197Uñ—
Solution:
5µg per mL.
Medium:
alcohol.
Absorptivities at 228nm,calculated on the dried basis,do not differ by more than 3.0%.
C:
To a solution of about 10mg in 0.5mLof alcohol add 1mLof hydrochloric acid and about 50mg 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 á741ñ:
between 227
and 234,but the range between beginning and end of melting does not exceed 3.
and 234,but the range between beginning and end of melting does not exceed 3.
Loss on drying á731ñ—
Dry it at 105for 2hours:it loses not more than 0.5%of its weight.
for 2hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.2%.
Assay—
Mobile phase,Internal standard solution,and Standard preparation—
Prepare as directed in the Assayunder Dienestrol Cream.
Assay preparation—
Transfer about 25mg of Dienestrol,accurately weighed,to a 100-mLvolumetric flask.Add methanol to volume,and mix.Pipet 2mLof this solution,5mLof Internal standard solution,and 5mLof water into a 50-mLvolumetric flask.Dilute with methanol to volume,and mix.
Procedure—
Proceed as directed for Procedurein the Assayunder Dienestrol Cream.Calculate the quantity,in mg,of C18H18O2in the portion of Dienestrol taken by the formula:
2.5C(RU/RS).
Auxiliary Information—
Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 631
Phone Number:1-301-816-8139