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Estradiol | CAS No: 50-28-2 | GMP-certified suppliers
A medication that addresses menopausal symptoms, hypoestrogenism, and postmenopausal bone loss, and provides palliative support in certain hormone‑responsive breast and prostate cancers.
Therapeutic categories
Adrenal Cortex HormonesAndrogens and EstrogensAnti-Gonadotropin-Releasing HormonesAntiandrogens and EstrogensBCRP/ABCG2 InhibitorsCOMT Substrates
Generic name
Estradiol
Molecule type
small molecule
CAS number
50-28-2
DrugBank ID
DB00783
Approval status
Approved drug, Investigational drug, Vet_approved drug
ATC code
G03FA16
Primary indications
- Estradiol is indicated in various preparations for the treatment of moderate to severe vasomotor symptoms and vulvar and vaginal atrophy due to menopause, for the treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure, and for the prevention of postmenopausal osteoporosis
- It is also used for the treatment of breast cancer (only for palliation therapy) in certain men or women with metastatic disease, and for the treatment of androgen-dependent prostate cancer (only for palliation therapy)
- It is also used in combination with other hormones as a component of oral contraceptive pills for preventing pregnancy (most commonly as , a synthetic form of estradiol)
- A note on duration of treatment**
Product Snapshot
- Estradiol is supplied as a small‑molecule estrogen available in oral, injectable, transdermal, topical, vaginal, and implantable formulations
- It is used for menopausal hormone therapy, hypoestrogenism conditions, palliative management of certain breast and prostate cancers, and as a hormone component in combination contraceptives
- It holds regulatory approvals across the US, Canada, and EU, with additional investigational and veterinary statuses noted
Clinical Overview
Estradiol (CAS 50-28-2) is an endogenous estrogen used therapeutically to manage conditions characterized by estrogen deficiency or altered estrogen balance. Clinical indications include moderate to severe vasomotor symptoms and vulvovaginal atrophy associated with menopause, hypoestrogenism from hypogonadism, castration, or primary ovarian failure, and prevention of postmenopausal osteoporosis. Estradiol is also applied as palliative therapy in selected cases of metastatic breast cancer and androgen‑dependent prostate cancer. In contraceptive applications, oral formulations commonly contain ethinyl estradiol, a synthetic analog with higher oral bioavailability.
Pharmacologically, estradiol exerts estrogenic effects across reproductive, skeletal, vascular, metabolic, and central nervous system tissues. It modulates gene transcription through ERα and ERβ and induces rapid signaling via G protein‑coupled estrogen receptors. Pharmacodynamic actions include suppression of pituitary FSH, improvement of vasomotor stability, maintenance of urogenital tissue integrity, and inhibition of bone resorption. Estradiol also increases hepatic synthesis of SHBG, TBG, and other estrogen‑regulated proteins, influencing systemic endocrine and metabolic profiles.
Oral estradiol undergoes extensive first‑pass metabolism, and esterified prodrugs are used in many oral and injectable products to enhance bioavailability. Estradiol and metabolites undergo hepatic biotransformation involving CYP3A and multiple other CYP isoforms, with conjugation and renal elimination contributing to clearance. Systemic exposure varies by route, with transdermal and vaginal systems minimizing first‑pass effects.
Safety considerations include risks of venous thromboembolism, stroke, and cardiovascular events, particularly with systemic estrogen exposure. Estrogen‑induced sodium retention may contribute to blood pressure elevations. Long‑term unopposed estrogen increases risk of endometrial hyperplasia in individuals with an intact uterus, supporting the need for concurrent progestin in hormone replacement regimens. Post‑WHI guidance generally recommends the lowest effective dose for the shortest feasible duration.
Branded and generic products exist across oral, injectable, transdermal, and intravaginal routes. For API procurement, key quality considerations include control of stereochemical integrity, impurity profiles, compliance with pharmacopeial monographs, and verification of manufacturing consistency to support global regulatory requirements.
Pharmacologically, estradiol exerts estrogenic effects across reproductive, skeletal, vascular, metabolic, and central nervous system tissues. It modulates gene transcription through ERα and ERβ and induces rapid signaling via G protein‑coupled estrogen receptors. Pharmacodynamic actions include suppression of pituitary FSH, improvement of vasomotor stability, maintenance of urogenital tissue integrity, and inhibition of bone resorption. Estradiol also increases hepatic synthesis of SHBG, TBG, and other estrogen‑regulated proteins, influencing systemic endocrine and metabolic profiles.
Oral estradiol undergoes extensive first‑pass metabolism, and esterified prodrugs are used in many oral and injectable products to enhance bioavailability. Estradiol and metabolites undergo hepatic biotransformation involving CYP3A and multiple other CYP isoforms, with conjugation and renal elimination contributing to clearance. Systemic exposure varies by route, with transdermal and vaginal systems minimizing first‑pass effects.
Safety considerations include risks of venous thromboembolism, stroke, and cardiovascular events, particularly with systemic estrogen exposure. Estrogen‑induced sodium retention may contribute to blood pressure elevations. Long‑term unopposed estrogen increases risk of endometrial hyperplasia in individuals with an intact uterus, supporting the need for concurrent progestin in hormone replacement regimens. Post‑WHI guidance generally recommends the lowest effective dose for the shortest feasible duration.
Branded and generic products exist across oral, injectable, transdermal, and intravaginal routes. For API procurement, key quality considerations include control of stereochemical integrity, impurity profiles, compliance with pharmacopeial monographs, and verification of manufacturing consistency to support global regulatory requirements.
Identification & chemistry
| Generic name | Estradiol |
|---|---|
| Molecule type | Small molecule |
| CAS | 50-28-2 |
| UNII | 4TI98Z838E |
| DrugBank ID | DB00783 |
Pharmacology
| Summary | Estradiol is an endogenous estrogen that acts as an agonist at ERα, ERβ, and GPER to regulate gene transcription and support estrogen‑responsive physiological processes. Its pharmacologic activity includes modulation of vasomotor and urogenital function, suppression of pituitary FSH, effects on bone resorption, and induction of hepatic protein synthesis. These actions reflect its role as the primary high‑affinity estrogen receptor ligand in states of low endogenous estrogen. |
|---|---|
| Mechanism of action | Estrogen is found in the the breast, uterine, ovarian, skin, prostate, bone, fat, and brain tissues. The main source of estrogen in adult women during the reproductive period of life is the ovarian follicle, which secretes 70 to 500 mcg of estradiol each day. After menopause, however, the majority of endogenous estrogen is produced by transformation of androstenedione (which is secreted by the adrenal cortex) to estrone in the peripheral tissues. Both estrone and its sulphate conjugated form, estrone sulphate, represent the most abundant estrogens found in postmenopausal women. Estradiol, however, is considerably more potent than estrone and estriol at the estrogen receptor (ER). As a result, the higher estrone concentration in postmenopausal population, can cause various undesirable effects. These effects may include hot flashes, chills, vaginal dryness, mood swings, irregular menstruation, and chills, in addition to sleep problems. Estradiol workings by binding to subtypes of the estrogen receptor: estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ). It also exerts potent agonism of G Protein-coupled estrogen receptor (GPER), which is recognized an important regulator of this drug's rapid effects. Once the estrogen receptor has bound to its ligand, it enters the nucleus of the target cell, regulating gene transcription and formation of of messenger RNA. This mRNA makes contact with ribosomes producing specific proteins that express the effect of estradiol upon the target cell. Agonism of estrogen receptors increases pro-estrogenic effects, leading to the relief of vasomotor and urogenital symptoms of a postmenopausal or low estradiol state. |
| Pharmacodynamics | Estradiol acts on the on the estrogen receptors to relieve vasomotor systems (such as hot flashes) and urogenital symptoms (such as vaginal dryness and dyspareunia). Estradiol has also been shown to exert favorable effects on bone density by inhibiting bone resorption. Estrogen appears to inhibit bone resorption and may have beneficial effects on the plasma lipid profile.Estrogens cause an increase in hepatic synthesis of various proteins, which include sex hormone binding globulin (SHBG), and thyroid-binding globulin (TBG). Estrogens are known to suppress the formation of follicle-stimulating hormone (FSH) in the anterior pituitary gland. **A note on hyper-coagulable state, cardiovascular health, and blood pressure** Estradiol may cause an increased risk of cardiovascular disease, DVT, and stroke, and its use should be avoided in patients at high risk of these conditions.Estrogen induces a hyper-coagulable state, which is also associated with both estrogen-containing oral contraceptive (OC) use and pregnancy. Although estrogen causes an increase in levels of plasma renin and angiotensin. Estrogen-induced increases in angiotensin, causing sodium retention, which is likely to be the mechanism causing hypertension after oral contraceptive treatment. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Estrogen receptor alpha | Humans | agonist |
| Estrogen receptor beta | Humans | agonist |
| Nuclear receptor subfamily 1 group I member 2 | Humans | binder |
ADME / PK
| Absorption | The absorption of several formulations of estradiol is described below: Oral tablets and injections First-pass metabolism in the gastrointestinal tract rapidly breaks down estradiol tablets before entering the systemic circulation.The bioavailability of oral estrogens is said to be 2-10% due to significant first-pass effects.The esterification of estradiol improves the administration (such as with estradiol valerate) or to sustain release from intramuscular depot injections (including estradiol cypionate) via higher lipophilicity.After absorption, the esters are cleaved, which leads to the release of endogenous estradiol, or 17β-estradiol. Transdermal preparations The transdermal preparations slowly release estradiol through intact skin, which sustains circulating levels of estradiol during a 1 week period of time. Notably, the bioavailability of estradiol after transdermal administration is about 20 times higher than after oral administration. Transdermal estradiol avoids first pass metabolism effects that reduce bioavailability. Administration via the buttock leads to a Cmax of about 174 pg/mL compared to 147 pg/mL via the abdomen. Spray preparations After daily administration, the spray formulations of estradiol reach steady state within 7-8 days. After 3 sprays daily, Cmax is about 54 pg/mL with a Tmax of 20 hours. AUC is about 471 pg•hr/mL. Vaginal ring and cream preparations Estradiol is efficiently absorbed through the mucous membranes of the vagina. The vaginal administration of estrogens evades first-pass metabolism. Tmax after vaginal ring delivery ranges from 0.5 to 1 hour. Cmax is about 63 pg/mL.The vaginal cream preparation has a Cmax of estradiol (a component of Premarin vaginal estrogen conjugate cream) was a Cmax of 12.8 ± 16.6 pg/mL, Tmax of 8.5 ± 6.2 hours, with an AUC of 231 ± 285 pg•hr/mL. |
|---|---|
| Half-life | The terminal half-lives for various estrogen products post oral or intravenous administration has been reported to range from 1-12 hours.One pharmacokinetic study of oral estradiol valerate administration in postmenopausal women revealed a terminal elimination half-life of 16.9 ± 6.0 h.A pharmacokinetic study of intravenous estradiol administration in postmenopausal women showed an elimination half-life of 27.45 ± 5.65 minutes.The half-life of estradiol appears to vary by route of administration. |
| Protein binding | More than 95% of estrogens are found to circulate in the blood bound to sex hormone binding globulin (SHBG) and albumin. |
| Metabolism | Exogenously administered estrogens are metabolized in the same fashion as endogenous estrogens. Metabolic transformation occurs primarily in the liver and intestine.Estradiol is metabolized to estrone, and both are converted to estriol, which is later excreted in the urine. Sulfate and glucuronide conjugation estrogens also take place in the liver. Biliary secretion of metabolic conjugates are released into the intestine, and estrogen hydrolysis in the gut occurs, followed by reabsorption.The CYP3A4 hepatic cytochrome enzyme is heavily involved in the metabolism of estradiol. CYP1A2 also plays a role. |
| Route of elimination | Estradiol is excreted in the urine with both glucuronide and sulfate conjugates. |
| Volume of distribution | Estrogens administered exogenously distribute in a similar fashion to endogenous estrogens. They can be found throughout the body, especially in the sex hormone target organs, such as the breast, ovaries and uterus. |
| Clearance | In one pharmacokinetic study, the clearance of orally administered micronized estradiol in postmenopausal women was 29.9±15.5 mL/min/kg.Another study revealed a clearance of intravenously administered estradiol was 1.3 mL/min/kg. |
Formulation & handling
- Low aqueous solubility and moderate lipophilicity support oral, topical, and transdermal formulations, typically requiring solubilizers or lipidic vehicles for consistent delivery.
- The small‑molecule steroid structure is chemically stable but can exhibit light and oxidation sensitivity, necessitating protection from light and appropriate antioxidant use in solution forms.
- Intramuscular and vaginal dosage forms rely on depot or mucoadhesive systems, where excipient selection influences release rate and local absorption.
Regulatory status
| Lifecycle | The API is marketed in the US, Canada, and the EU, with core patent protections in the US and Canada having expired between 2010 and 2022. Given these expiries across major markets, the product is in a late‑lifecycle phase with mature generic availability expected or already established. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Estradiol has been developed and supplied by numerous originator and specialty pharmaceutical companies, with a wide network of manufacturers and packagers supporting its long‑established therapeutic use. Branded and generic estradiol products are broadly available across the US, Canada, and EU. Key patents have expired in all major markets, indicating an established landscape of generic competition and mature supply options. |
|---|
Safety
| Toxicity | The NOAEL (no-observed-adverse-effect-level) oral toxicity of estradiol after 90 day in rats was 0.003 mg/kg/day for blood, female reproductive, and male reproductive, endocrine, and liver toxicity.Oral TDLO of ethinyl estradiol is 21 mg/kg/21D intermittent, woman) with an oral LD50 of 960 mg/kg in the rat. There is limited information in the literature regarding estrogen overdose. Estradiol overdose likely leads to the occurrence of estrogen-associated adverse effects, including nausea, vomiting, abdominal pain, breast tenderness, venous thrombosis, and vaginal bleeding.It is generally recommend to discontinue estradiol treatment and offer supportive care in the case of an overdose. |
|---|
High Level Warnings:
- Estradiol shows very low NOAEL values in 90‑day rat studies (0
- 003 mg/kg/day), with identified targets including reproductive organs, endocrine tissues, blood, and liver
- Ethinyl estradiol presents an oral LD50 of approximately 960 mg/kg in rats, with human TDLO data indicating potential for systemic toxicity at repeated high exposures
Estradiol is a type of Estrogens
Estrogens are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in hormone therapy and women's health. Estrogens are a class of steroidal compounds that are primarily produced in the ovaries and play a significant role in the development and maintenance of female reproductive tissues and secondary sexual characteristics. These APIs are widely used in various pharmaceutical formulations, including oral contraceptives, hormone replacement therapies, and treatments for menopausal symptoms. They are also utilized in the management of conditions such as hypogonadism, infertility, and certain types of cancer.
Estrogens exert their effects by binding to estrogen receptors, which are present in various tissues throughout the body. This binding initiates a cascade of cellular and molecular events that regulate gene expression and modulate physiological processes.
Some common examples of estrogens used in pharmaceutical formulations include estradiol, estrone, and estriol. These compounds are typically synthesized from natural sources or derived from plant-based substances through a series of chemical reactions and purification processes.
As with any pharmaceutical API, the production of estrogens follows strict quality control guidelines to ensure purity, potency, and safety. Stringent regulatory standards and rigorous testing protocols are employed to guarantee consistent quality and adherence to pharmaceutical industry regulations.
In conclusion, estrogens are a vital subcategory of pharmaceutical APIs with a wide range of applications in women's health and hormone therapy. Their role in maintaining hormonal balance and addressing various medical conditions underscores their importance in modern medicine.
Estradiol (Estrogens), classified under Hormonal Agents
Hormonal agents are a prominent category of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the medical field. These substances play a crucial role in regulating and modulating hormonal functions within the body. Hormonal agents are designed to mimic or manipulate the effects of naturally occurring hormones, allowing healthcare professionals to treat various endocrine disorders and hormonal imbalances.
Hormonal agents are commonly employed in the treatment of conditions such as hypothyroidism, hyperthyroidism, diabetes, and hormonal cancers. These APIs work by interacting with specific hormone receptors, either by stimulating or inhibiting their activity, to restore the balance of hormones in the body. They can be administered orally, intravenously, or through other routes depending on the specific medication and patient needs.
Pharmaceutical companies employ rigorous manufacturing processes and quality control measures to ensure the purity, potency, and safety of hormonal agent APIs. These APIs are synthesized using chemical or biotechnological methods, often starting from natural hormone sources or through recombinant DNA technology. Stringent regulatory guidelines are in place to guarantee the efficacy and safety of hormonal agent APIs, ensuring that patients receive high-quality medications.
As the demand for hormone-related therapies continues to grow, ongoing research and development efforts focus on enhancing the effectiveness and reducing the side effects of hormonal agent APIs. This includes the exploration of novel delivery systems, advanced formulations, and targeted drug delivery methods. By continuously advancing our understanding and capabilities in hormonal agents, the medical community can improve patient outcomes and quality of life for individuals with hormonal disorders.
Estradiol API manufacturers & distributors
Compare qualified Estradiol API suppliers worldwide. We currently have 17 companies offering Estradiol API, with manufacturing taking place in 7 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Bayer | Producer | Germany | Unknown | CEP, CoA, GMP, JDMF, KDMF, USDMF | 42 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | France | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Gedeon Richter | Producer | Hungary | Unknown | CEP, CoA, FDA, GMP, USDMF | 48 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| Metapharmaceutical Indust... | Producer | Spain | India | BSE/TSE, CEP, CoA, GDP, GMP, MSDS, WC, WHO-GMP | 21 products |
| Minakem | Producer | France | France | CoA, FDA, GMP, USDMF | 31 products |
| Pharmacia & Upjohn | Producer | United States | United States | CoA, USDMF | 30 products |
| Sanofi | Producer | France | France | CoA, GMP | 93 products |
| Senova Technology Co., Lt... | Producer | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF, WC | 157 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 757 products |
| Symbiotec Pharma | Producer | India | India | CoA, GMP, WC | 50 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 134 products |
| Zhejiang Xianju | Producer | China | China | CoA, USDMF | 17 products |
When sending a request, specify which Estradiol API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Estradiol API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Estradiol API
Sourcing
What matters most when sourcing GMP-grade Estradiol?
Key considerations include verifying that the API is manufactured under GMP and aligned with regulatory expectations in the US, Canada, and the EU. Consistent quality, documented traceability, and reproducible impurity control are essential due to Estradiol’s long‑established use. Given the mature, generic supply landscape, assessing supplier compliance history and supply reliability is also important.
Which documents are typically required when sourcing Estradiol API?
Request the core API documentation set: CoA (15 companies), GMP (11 companies), USDMF (10 companies), CEP (6 companies), MSDS (5 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Estradiol API?
Known or reported manufacturers for Estradiol: Caesar & Loretz GmbH (CAELO), Senova Technology Co., Ltd., Aurora Industry Co., Ltd, Sinoway industrial Co.,Ltd, Minakem, LGM Pharma, Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Estradiol API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Estradiol manufacturers?
Audit reports may be requested for Estradiol: 5 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Estradiol API on Pharmaoffer?
Reported supplier count for Estradiol: 15 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Estradiol API?
Production countries reported for Estradiol: China (5 producers), France (3 producers), India (3 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Estradiol usually hold?
Common certifications for Estradiol suppliers: CoA (15 companies), GMP (11 companies), USDMF (10 companies), CEP (6 companies), MSDS (5 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Estradiol (CAS 50-28-2) used for?
Estradiol is used to treat symptoms of estrogen deficiency, including moderate to severe vasomotor symptoms and vulvovaginal atrophy associated with menopause. It is also used for hypoestrogenism due to hypogonadism, castration, or primary ovarian failure; for prevention of postmenopausal osteoporosis; and as palliative therapy in certain metastatic breast cancers and androgen‑dependent prostate cancer. In contraceptive products, a synthetic analog such as ethinyl Estradiol is typically used instead of Estradiol itself.
Which therapeutic class does Estradiol fall into?
Estradiol belongs to the following therapeutic categories: Adrenal Cortex Hormones, Androgens and Estrogens, Anti-Gonadotropin-Releasing Hormones, Antiandrogens and Estrogens, BCRP/ABCG2 Inhibitors. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Estradiol mainly prescribed for?
The primary indications for Estradiol: Estradiol is indicated in various preparations for the treatment of moderate to severe vasomotor symptoms and vulvar and vaginal atrophy due to menopause, for the treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure, and for the prevention of postmenopausal osteoporosis, It is also used for the treatment of breast cancer (only for palliation therapy) in certain men or women with metastatic disease, and for the treatment of androgen-dependent prostate cancer (only for palliation therapy), It is also used in combination with other hormones as a component of oral contraceptive pills for preventing pregnancy (most commonly as , a synthetic form of Estradiol), A note on duration of treatment**. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Estradiol work?
Estrogen is found in the the breast, uterine, ovarian, skin, prostate, bone, fat, and brain tissues. The main source of estrogen in adult women during the reproductive period of life is the ovarian follicle, which secretes 70 to 500 mcg of Estradiol each day. After menopause, however, the majority of endogenous estrogen is produced by transformation of androstenedione (which is secreted by the adrenal cortex) to estrone in the peripheral tissues. Both estrone and its sulphate conjugated form, estrone sulphate, represent the most abundant estrogens found in postmenopausal women.
Estradiol, however, is considerably more potent than estrone and estriol at the estrogen receptor (ER). As a result, the higher estrone concentration in postmenopausal population, can cause various undesirable effects. These effects may include hot flashes, chills, vaginal dryness, mood swings, irregular menstruation, and chills, in addition to sleep problems.
Estradiol workings by binding to subtypes of the estrogen receptor: estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ). It also exerts potent agonism of G Protein-coupled estrogen receptor (GPER), which is recognized an important regulator of this drug's rapid effects. Once the estrogen receptor has bound to its ligand, it enters the nucleus of the target cell, regulating gene transcription and formation of of messenger RNA. This mRNA makes contact with ribosomes producing specific proteins that express the effect of Estradiol upon the target cell. Agonism of estrogen receptors increases pro-estrogenic effects, leading to the relief of vasomotor and urogenital symptoms of a postmenopausal or low Estradiol state.
What should someone know about the safety or toxicity profile of Estradiol?
Estradiol shows high potency with low NOAEL values in animal studies, and repeated exposure can affect reproductive organs, endocrine tissues, blood, and liver. Systemic use is associated with risks such as venous thromboembolism, stroke, cardiovascular events, sodium retention, and blood pressure increases. Unopposed long‑term estrogen can lead to endometrial hyperplasia in individuals with an intact uterus, necessitating progestin co‑administration. Very high oral exposures to related compounds such as ethinyl Estradiol have produced systemic toxicity in animals and humans.
What are important formulation and handling considerations for Estradiol as an API?
Important considerations include managing Estradiol’s low aqueous solubility and moderate lipophilicity, which often require solubilizers, lipidic vehicles, or depot‑forming excipients for consistent release. Light and oxidation sensitivity necessitate protection from light and, for solutions, the use of suitable antioxidants. Transdermal, vaginal, and intramuscular systems should be designed to control release and optimize absorption, with excipients selected to support depot formation or mucosal uptake. Handling should maintain chemical stability and prevent degradation during manufacturing and storage.
Is Estradiol a small molecule?
Estradiol is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Estradiol?
Oral Estradiol is chemically stable but shows sensitivity to light and oxidation, so protection from light and the use of antioxidants in solution forms are important. Its low aqueous solubility may require solubilizers or lipid‑based excipients to maintain uniform drug delivery in tablets or capsules. These factors help ensure consistent potency and minimize degradation during storage and use.
Regulatory
Where is Estradiol approved or in use globally?
Estradiol is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Estradiol right now?
Estradiol is an established active pharmaceutical ingredient with regulatory approvals in major regions, including the United States, Canada, and the European Union, for multiple therapeutic uses. It is available in numerous generic formulations, and core compound patents have long expired. Remaining protections, where applicable, relate to specific formulations or delivery systems rather than the API itself.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Estradiol procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Estradiol. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Estradiol included in the PRO Data Insights coverage?
PRO Data Insights coverage for Estradiol: 2319 verified transactions across 448 suppliers and 352 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Estradiol?
Market report availability for Estradiol: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
