Citations for: British Pharmacopoeia 2017: Ethinylestradiol monograph

Entry Type
Name
Value
Parent Entry
Impurities Data Field
The C6-C7 single bond in EE is converted to a C6=C7 double bond.
19-Nor-17α-pregn-1,3,5(10),6-tetraen-20-yne-3,17-diol (Impurity)
Impurities Data Field
Oxidation
19-Nor-17α-pregn-1,3,5(10),6-tetraen-20-yne-3,17-diol (Impurity)
Impurities Data Field
The H group of EE's C4 is replaced with a methyl group in this impurity.
4-Methyl-ethinylestradiol (Impurity)
Impurities Data Field
The H EE's C1 is replaced with a methyl group
1-Methyl-ethinylestradiol (Impurity)
Impurities Data Field
The C16 aliphatic carbon is replaced with a carbonyl carbon
16-Oxo-ethinylestradiol (Impurity)
Impurities Data Field
The C6 aliphatic carbon in EE changes to a carbonyl carbon
6-Ketoethinyl Estradiol (Impurity)
Impurities Data Field
One of the H's at C6 of EE is replaced with an OH group.
6α-Hydroxyethinyl Estradiol (Impurity)
Impurities Data Field
Oxidative hydroxylation of EE at C6.
6α-Hydroxyethinyl Estradiol (Impurity)
Impurity
N/A
Impurities Data Field
The ethinyl group of EE is replaced with a H group.
Estradiol (Impurity)
Impurities Data Field
Synthetic impurity; loss of ethinyl group;
Estradiol (Impurity)
Impurity
N/A
Impurities Data Field
The C9-C11 single bond in EE is replaced with a C9=C11 double bond.
9(11)-Dehydroethinyl Estradiol (Impurity)
Impurities Data Field
8-dehydroethinyl estradiol is an intermediate in the ethinylation of estrone and the δ8 double bond easily isomerizes to the δ9(11) position.
9(11)-Dehydroethinyl Estradiol (Impurity)
Impurities Data Field
synthetic impurity
17β-Ethinyl Estradiol (Impurity)
Physical & Chemical Properties Data Field
White or slightly yellowish-white, crystalline powder
Ethinyl Estradiol (API)
Physical & Chemical Properties Data Field
BP: practically insoluble in water.
PubChem: 11.3 mg/L water at 27 °C.
PubChem, BP: 1 part in 6 of ethanol, 1 in 4 of ether, 1 in 5 of acetone, 1 in 4 of dioxane, and 1 in 20 of chloroform. Soluble in vegetable oils, and in solutions of fixed alkali hydroxides (e.g. NaOH, KOH)
Ethinyl Estradiol (API)
Physical & Chemical Properties Data Field
Yes
Ethinyl Estradiol (API)
Physical & Chemical Properties Data Field
Protect from light
Ethinyl Estradiol (API)