Name: Ethinyl Estradiol
Spec.: 99% HPLC
Appearance: White powder
Other name: Ethinylestradiol;EE;Estinyl
EINECS No.: 200-342-2
CAS: 57-63-6
M.F.: C20H24O2
M.W.: 296.4
Ethinyl estradiol, also sometimes written as ethinylestradiol, ethynyl estradiol, or ethinyl œstradiol, is a derivative of 17β-estradiol(E2), the major endogenousestrogen in humans. EE is an orally bioactive estrogen used in many formulations of combined oral contraceptive pills. It is one of the most commonly used medications for this purpose.
Transdermal ethinyl estradiol carries a greater risk of clot formation and venous thromboembolism than 17 beta estradiol, which some have theorized to be related to different amounts of hepatic metabolism after absorption. The same contraindications and precautions apply for EE as with other estrogen medications.
Estinyl was a preparation of EE alone that was used for the management of menopausal symptoms and female hypogonadism.
EE is released into the environment as a xenoestrogen from the urine and feces of people who take it as a medication.
The major concern with unopposed estrogen is of endometrial cancer. The medication is generally prescribed withprogesterone in the setting of birth control.
| Item | Standard | Test Results | |
Identification | A.H-NMR:Comply with the structure | Complies | |
B.LC-MS:Comply with the structure | Complies | ||
C.The IR spectrum of sample should be identical with that of reference standard; | Complies | ||
D.HPLC-ESI-MS The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. | Complies | ||
Crystallinity | meets the requirements. | Complies | |
Loss on drying | ≤2.0% | 0.19% | |
Heavy metals | ≤10 ppm | <10ppm | |
Water | ≤1.0% | 0.1% | |
Sulphated ash | ≤0.5%, determined on 1.0 g. | 0.009% | |
Related substances | Unspecified impurities: for each impurity | ≤0.10% | <0.10% |
Total Impurity | ≤0.5% | 0.18% | |
Purity | ≥99.0% | 99.7% | |
Assay | 99.0%~101.0% | 99.8% | |
Microbiological Analysis | |||
Total plate count | ≤1000cfu/g | Complies | |
Yeast and Moulds | ≤100cfu/g | Complies | |
E. Coli. | Absent | Negative | |
Salmonella | Absent | Negative | |
S.aureus | Absent | Negative | |
Storage | Preserve in well-closed, light-resistant and airtight containers. | Complies | |