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Ethynyl estradiol is used to supplement estrogen deficiencies and treat female gonadal dysfunction, amenorrhea, menopausal syndrome, etc.; it can also be used for the treatment of advanced breast cancer and advanced prostate cancer.
Items | Specifications | Results |
Appearance | White or off-white crystalline powder | Off-white crystalline powder |
Solubility | Practically insoluble in water,freely soluble in ethanol(96% per cent),It dissolves in dilute alkaline solutions. | Conforms |
Identification | IR:The spectra obtained with the sample should be consistent to that of the reference standard. | Conforms |
TLC:The principal spot in the chromatogram obtained with the test solution is similar in position,colour,fluorescence and size to the principal spot in the chromatogram obtained with the reference solution. | Conforms | |
Loss on drying | ≤1.0% | 0.83% |
Related substances(By HPLC,%Area) | Impurity B≤0.5% Impurity H≤0.2% Impurity I≤0.2% Impurity K≤0.2% Impurity C≤0.15% Impurity F≤0.15% Unspecified impurities ≤0.10% Total impurities≤0.8% | 0.02% Not Detected Not Detected Not Detected Not Detected 0.04% 0.15% |
Assay(By HPLC,%w/w) | 97.0%-102.0%(on dried basis) | 99.4% |
Residual solvents(By GC,%w/w) | Acetone≤5000ppm Toluene≤890ppm Tetrahydrofuran≤720ppm Isobutyl alcohol≤5000ppm Benzene≤2ppm | 454.5ppm Not Detected Not Detected Not Detected Not Detected |
Granularity | D[90]≤20um | Conforms |
Conclusion | The product conforms to the above specifications. | |
| Product parameters | |
| Cas number: | 57-63-6 |
| Appearance: | white crystalline powder |
| Purity: | 97.0～102.0% |
| Package details: | 1kg/bag |
| Brand: | Fortunachem |
Uses:
Ethinyl Estradiol (EE), also known as ethinylestradiol, is a semisynthetic steroidal estrogen derived from natural estradiol (17β-estradiol). Its molecular formula is C₂₀H₂₄O₂, with a molecular weight of 296.4 g/mol, and CAS number 57-63-6. Its chemical name is (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol.
It is a 17α-ethynyl derivative of estradiol — meaning a single ethynyl group (–C≡CH) is added at the 17α position of the estradiol molecule. This seemingly small structural modification is what gives EE its remarkable pharmaceutical properties: it makes the molecule resistant to first-pass hepatic metabolism, dramatically improving oral bioavailability.
EE appears as a white to creamy white crystalline powder, odorless, practically insoluble in water but soluble in organic solvents such as ethanol, acetone, and chloroform.
EE was first synthesized in 1938 by Hans Herloff Inhoffen and Walter Hohlweg at Schering AG in Berlin, and was introduced for medical use in 1943. It began being used in birth control pills in the 1960s and has since become the most widely used estrogen in modern pharmacotherapy — found in virtually all combined oral contraceptive (COC) formulations worldwide.
Key Selling Points
1. Exceptional Oral Bioavailability — 10–30× More Potent Than Natural Estradiol
The 17α-ethynyl group protects EE from rapid degradation by liver enzymes (particularly 17β-hydroxysteroid dehydrogenase). This gives EE an oral biological activity 10 to 30 times greater than natural estradiol, with an oral bioavailability of approximately 40–60% (highly variable between individuals). This makes it far more practical and cost-effective for oral formulations than natural estrogens.
2. High Metabolic Stability — Long Duration of Action
EE is metabolized slowly in the liver, giving it a half-life of 6–14 hours and a duration of action of 1–2 days. This allows for reliable once-daily dosing and consistent hormone levels, which is critical for contraceptive efficacy and cycle control.
3. Proven, Decades-Long Clinical Track Record
With over 80 years of clinical use since 1943, EE is one of the most extensively studied drugs in history. Billions of women worldwide have used EE-containing products, providing an enormous body of safety and efficacy data.
4. Versatile Delivery Systems
EE is formulated across multiple delivery platforms:
Oral tablets (combined oral contraceptives — monophasic, biphasic, triphasic, extended-cycle)
Transdermal patches (e.g., Ortho Evra/Xulane, Gwyn Lo — FDA-approved July 2026)
Vaginal rings (e.g., NuvaRing, Annovera — year-long reusable ring)
This flexibility allows patient-specific selection based on preference, compliance needs, and clinical situation.
5. Superior Cycle Control and Compliance
EE-containing COCs provide reliable menstrual cycle regulation. Transdermal patch formulations have demonstrated higher rates of perfect compliance than oral contraceptives, since they require only weekly (or less frequent) application rather than daily pill-taking.
6. Broad Therapeutic Scope Beyond Contraception
EE is not just a contraceptive — it addresses multiple estrogen-deficient conditions, gynecological disorders, dermatological conditions, and certain hormone-sensitive cancers, making it a multi-industry workhorse molecule.
Major Uses & Applications
💊 Combined Hormonal Contraception (Primary Use)
This is EE's largest and most important application. EE is the estrogen component in virtually all combined oral contraceptive pills (COCs), combined with various progestins:
Mechanism: EE suppresses the hypothalamic-pituitary-ovarian (HPO) axis by inhibiting GnRH release, which in turn suppresses FSH and LH secretion. This prevents ovarian follicle maturation and inhibits ovulation. Combined with a progestin, it also thickens cervical mucus (blocking sperm penetration) and alters the endometrium (reducing implantation probability).
Typical EE doses in COCs: 20–35 μg/day (low-dose formulations); historically up to 50 μg
Common progestin partners: levonorgestrel, desogestrel, norgestimate, drospirenone, cyproterone acetate, norethindrone, norelgestromin
Pearl Index (failure rate): approximately 0.3–0.5 with perfect use; ~4–9 with typical use
Market scale: The global hormonal contraceptive market was valued at $19 billion in 2022, with EE-containing products dominating the segment
Hormone Replacement Therapy (HRT)
Menopausal symptom relief: EE is used for estrogen replacement in women experiencing vasomotor symptoms (hot flashes, night sweats), vulvovaginal atrophy, and dyspareunia due to menopause
Osteoporosis prevention: In postmenopausal women at high risk of fractures who cannot tolerate other approved osteoporosis medications, EE helps maintain bone mineral density by increasing calcium deposition in bones
Typical HRT dose: 10–50 μg daily, usually on a cyclical basis (3 weeks on, 1 week off)
Female hypogonadism / gonadal dysgenesis: Used for hormone replacement in women with primary ovarian insufficiency or delayed puberty, initially as estrogen-only therapy, later combined with progestogen
Gynecological Disorders
Menstrual cycle regulation: Treatment of amenorrhea, oligomenorrhea, dysfunctional uterine bleeding, and dysmenorrhea
Endometriosis: Suppression of endometrial tissue growth and pain management through continuous hormonal suppression
Polycystic Ovary Syndrome (PCOS): Reduces hyperandrogenism symptoms (hirsutism, acne) and regulates menstrual cycles
💆 Dermatology — Acne Treatment
EE-containing COCs are FDA-approved for moderate acne vulgaris in females ≥15 years of age who have achieved menarche and desire oral contraception
Mechanism: EE increases sex hormone-binding globulin (SHBG), which reduces free circulating androgens (testosterone), thereby decreasing sebum production and acne
Common formulations for acne: norgestimate/EE (Ortho Tri-Cyclen), norethindrone/EE, cyproterone/EE (Dianette)
Oncology — Palliative Cancer Treatment
Prostate cancer: EE is used in palliative care for advanced/metastatic prostate cancer. It inhibits 5-α-reductase in epididymal tissue, lowering testosterone levels and potentially delaying cancer progression. Dose: 0.15–1.5 mg/day
Postmenopausal breast cancer: Historically used for advanced breast cancer in postmenopausal women, though largely replaced by more targeted therapies (tamoxifen, aromatase inhibitors) in modern practice
Transdermal & Vaginal Delivery Systems
Contraceptive patches: EE/norelgestromin patches (e.g., Xulane, Gwyn Lo) deliver 20 μg EE/day transdermally, applied weekly for 3 weeks followed by 1 patch-free week
Vaginal rings: Segesterone acetate/EE rings (Annovera) provide year-long, user-controlled reversible contraception
Dosage Forms & Specifications
| Form | EE Content | Application |
|---|---|---|
| COC tablets (low-dose) | 20–35 μg/day | Daily oral contraception |
| COC tablets (standard) | 50 μg/day | Oral contraception (older formulations) |
| HRT tablets | 10–50 μg/day | Menopausal symptoms, osteoporosis prevention |
| Monotherapy tablets | 5–500 μg | Estrogen deficiency, cancer palliation |
| Transdermal patch | 20 μg/day release | Weekly contraception |
| Vaginal ring | 15 μg/day release | Monthly or yearly contraception |
Safety Profile & Contraindications
Common Side Effects
Nausea, headache, breast tenderness/enlargement, fluid retention, breakthrough bleeding, mood changes, weight changes
Serious Risks (Rare)
Thromboembolic events (DVT, PE) — risk increased in smokers, overweight women, and those with thrombophilia history
Hepatic adenomas — rare, associated with long-term use
Cardiovascular events — stroke, myocardial infarction (primarily in high-risk populations)
Absolute Contraindications
History of or active thromboembolic disease (DVT, PE, stroke)
Known or suspected estrogen-dependent neoplasia (breast cancer, endometrial cancer)
Undiagnosed abnormal uterine bleeding
Severe liver disease or liver tumors
Pregnancy
Summary of Selling Points at a Glance
| Selling Point | Detail |
|---|---|
| Oral potency | 10–30× more potent than natural estradiol |
| Bioavailability | 40–60% oral absorption (vs. very low for estradiol) |
| Half-life | 6–14 hours, enabling once-daily dosing |
| Clinical history | 80+ years of use since 1943 |
| Delivery versatility | Tablets, patches, vaginal rings |
| Market dominance | Found in virtually all COCs globally |
| Multi-indication | Contraception, HRT, acne, PCOS, endometriosis, cancer palliation |
| Market size | Part of $19B global hormonal contraceptive market (2022) |
In short, Ethinyl Estradiol's core competitive advantage is its 17α-ethynyl structural modification, which confers exceptional oral bioavailability and metabolic stability that natural estradiol simply cannot match. This single chemical innovation made reliable oral hormonal contraception possible and has made EE the cornerstone estrogen in reproductive medicine, gynecology, dermatology, and oncology for over eight decades. Despite the emergence of newer natural estrogen formulations, EE remains the gold standard estrogen component in combined hormonal contraceptives due to its proven efficacy, predictable pharmacokinetics, and unmatched clinical track record.
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FAQ From Wuhan Fortuna Chemical Co.,Ltd
Q1: Can I get a sample for free ?
A: For small QTY and low value product, we can provide sample for free exclude shipping cost. For high value sample, we will charge the basic sample cost, but we can refund all the cost if customers place order after sample test.
Q2: How to confirm the product quality before placing orders ?
A: Most of our products confirm to international standards like USP/EP/BP/JP/CP. We will provide COA/TDS/MSDS for customers to confirm the specification before placing order.
Q3: What is the payment you accept?
A: For small and low value order, we accept CreditCard, MaterCard,VISA,Western Union and T/T.For large order, we can do T/T and L/C. Any pay on delivery or pay-after are not available for us.
Q4: What is your shipment way ?
A: For less than 100kg gross weight order will ship with courier like FedEx or UPS, we support customers to place courier orders remotely by their account, we will package the goods well and wait for pick up.For more than 100kg goods, we will transport by Air or Sea according to customers' requirement.
Q5: How long is your after-sales service?
A: We accept customer’s quality complaint in three month after customer received the goods. We provide tech.support for all-life if customer place order from our company.
Q6: How do you treat quality complaint ?
A: We support customer to provide our products to any rightful third party testing organization to test our products according to the COA specification, if the test result is confirm with COA, we will take all the loss for customers.
Name:Wuhan Fortuna Chemical Co.,Ltd
Category:Others
Trade Category: Trading Company
Employees: 11 - 50 People
Address: Room 2015, No.2 Building, Kaixin Mansion No.107
Company Information: Wuhan Fortuna Chemical Co.,Ltd established in 2006, is a big integrative chemical enterprise being engaged in Pharmaceutical and Intermediates, Food and Feed additives, Fine chemicals,Biochemical and Reagent, which is the members of Hubei E-commerce Chamber.
Our company has professional persons who major in chemical R&D and sicentific management, supply fine chemical products with high quality and close service, also supply custom-tailored products according to our clients' requirement.
We have a positive and self-motivated management work team with a common philosophy, caring and commitment through teamwork, our team strive to achieve success in delighting our clients and ourselves.
Since Wuhan Fortuna Chemical Co., Ltd founded, we continuously innovate our products and improve our service, sales network. Hence, we initiate the first sale mode on net in China, which is the retail trade of small package bring along wholesale of diversified management modes. Our products are exported widely to South Korea, Vietnam, Australia, Europe and South America, highly recommended by our clients.We insist on the management creed “Market is our compass, Quality is our life, Credit is our soul”. Clients’ trust is our forward power, their satisfaction is our struggling goal.
Wuhan Fortuna Chemical Co.,Ltd is a professional manufacturer which provide Ethynyl Estradiol with good quality and best price, welcome to contact us to get COA/TDS/MSDS of Ethynyl Estradiol.
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