Fulvestrant API

CAS No: 129453-61-8
Appearance: white to off-white powder
Standard: USP
Supply Ability: 50kg per month
Shelf Life: Two years
Payment: T/T, LC or DA
Delivery Time: Ready Stock
Origin: China
Shipping: DHL, FedEx, TNT, EMS, By Sea, By Air
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Product Introduction

We supply Fulvestrant API

We offer Fulvestrant API, a potent estrogen receptor antagonist used in the treatment of bone cancer. This high- quality API is manufactured using state of the art technology and is available in bulk amounts to meet the conditions of pharmaceutical companies worldwide. Our products undergoes rigorous quality control procedures to insure the chastity and efficacity of the final product. With our commitment to client satisfaction, we're devoted to furnishing our guests with timely and dependable delivery of our Fulvestrant. Trust us to deliver a decoration- quality API that meets your requirements and exceeds your prospects.

 

What's Fulvestrant API?

Fulvestrant API is a purified and high- quality active pharmaceutical component that's used in the product of medicines used to treat bone cancer. It works by blocking the estrogen receptors in bone cancer cells, which eventually slows or stops the growth of cancer cells. It's a picky estrogen receptor inveigler( SERD) and is a potent anticancer medicine that's extensively used in the medical assiduity.

Fulvestrant powder is a crystalline greasepaint that's largely answerable in organic detergents similar as ethanol, ethyl acetate, and dimethyl sulfoxide. It has a molecular weight of606.77 and a molecular formula of C32H47F5O3S. Its chastity is above 99 and it meets colorful nonsupervisory conditions established by global governmental agencies similar as the US FDA, European Pharmacopoeia, and Japanese Pharmacopoeia.

It's used in the product of colorful medicines used to treat advanced bone cancer in postmenopausal women whose cancer has spread to other areas of the body. It can be used as a monotherapy or in combination with other medicines similar as palbociclib, ribociclib, or abemaciclib. It has been proven effective in dragging progression-free survival in advanced bone cancer cases and has smaller side goods than other common anticancer medicines.

 

Basic Information

Product Name: Fulvestrant

CAS NO. : 129453-61-8

MF: C32H47F5O3S

MW: 606.77

EINECS No.: 642-998-6

MDL No.: MFCD00903953

Structural formula:

product-1-1

Purity: 99%+

Origin: China

Application: Anti cancer

Delivery Time: stock

Melting point: 104-106 ° C

Boiling point: 674.8 ± 55.0 ° C (Predicted)

Density: 1.201 ± 0.06g/cm3 (Predicted)

Solubility: dimethyl sulfoxide:>5Chemicalbookmg/mL

Acidity coefficient: (pKa) 10.27 ± 0.70 (Predicted)

Stability: Stable for 2 years from the date of purchase. DMSO or ethanol solution can be stored at -20 ° C for up to 3 months.

 

Technical Specification:

TEST

SPECIFICATION

RESULT

Appearance

White to off-white powder

Off -white powder

Solubility

Practically insoluble in water, freely soluble in
ethanol (96 percent) and in methylene chloride.

Conforms

Appearance of solution

The solution is clear

Conforms

Identification A

IR

Conforms

Identification B

HPLC

Conforms

Specific Rotation

+108° to +115°

+111.5°

Water

Not More Than 0.5%

0.1%

Sulphated Ash

Not More Than 0.1%

<0.1%

Heavy Metals

Not More Than 20ppm

<10ppm

Chromatographic Purity

 

 

Single impurity

Not More Than 0.5%

0.06%

Total impurities

Not More Than 1.0%

0.16%

Ratio of isomers

 

 

Fulvestrant A

42%~48%

45%

Fulyestrant B

52%~58%

55%

Assay

≥99.0%

99.84%

Residual Solvent

 

 

Toluene

Not More Than 890ppm

300ppm

Ethyl acetate

Not More Than 5000ppm

1000ppm

CONCLUSION: THE RESULTS CONFORM WITH ENTERPRISE STANDARD.

Package: 10g;50g;100g

Storage conditions: Keep in dark place, Inert atmosphere,2-8°C

 

Safety Information

WGK Germany: 3

RTECS NO. : KG7623000

Customs code: 2937230000

Toxicity: 129453-61-8(Hazardous Substances Data)

 

 

Synthetic route

Add the corresponding dienone compounds to the solution of Grignard reagent (9-pentafluoropentathiononyl bromide dissolved in tetrahydrofuran solution containing magnesium shavings, and add a small amount of iodine to initiate the reaction to obtain Grignard reagent). After the reaction is complete, add a tetrahydrofuran solution of acetic acid to terminate the reaction. Add water, steam out tetrahydrofuran, then add water and extract with cyclohexane. After washing the extraction solution with potassium chloride aqueous solution, steam out cyclohexane, add acetonitrile, and slowly add copper bromide, lithium bromide, and acetic anhydride. Put the reaction solution into a mixture of thiourea, toluene, and water, and cool it. Adjust the pH to 3 using potassium dihydrogen phosphate and filter to remove the precipitated copper. Wash the filter cake with toluene, merge the organic layers, and wash with sodium chloride aqueous solution. Steam out toluene, add methanol, add sodium hydroxide aqueous solution, and heat. The reaction solution was extracted with cyclohexane and neutralized with acetic acid. Steam out methanol and distribute the resulting substance between water and ethyl acetate. Concentrate the organic layer, then add ethyl acetate, acetic acid, and hydrogen peroxide, and stir the reaction. Add ethyl acetate and then sodium sulfite aqueous solution to destroy excess hydrogen peroxide. Neutralize with sodium hydroxide, separate the organic layer, and wash with water. Steam out the solvent and add seed crystals to promote crystallization. Crystals are washed with cold ethyl acetate, and then recrystallized with ethyl acetate to obtain Fulvestrant.

 

Pharmacological action

Fulvestrant is a type of steroid antiestrogenic drug with a chemical structure similar to estradiol, but it differs in that it is present in 7 α Positioned with connecting groups; It is 17 β- The alkylamine analogue of estradiol can antagonize the estrogenic effect by occupying ER and inhibit the activation of the basal chemobook stimulated by estrogen, thus affecting the estrogen related processes necessary for cellular circulation; Its affinity with ER is close to estrogen, but it is 100 times that of tamoxifen. Apoptosis is crucial in maintaining homeostasis in the body, and it may also be another major mechanism of the therapeutic effect of fluvoxetine. It is suitable for the treatment of estrogen receptor positive metastatic breast cancer in postmenopausal women whose disease is still worsening after anti estrogen treatment. Many breast cancer cells have estrogen receptors (ER), which can stimulate the growth of such tumors.

 

What is the application?

Fulvestrant API is classified as an estrogen receptor antagonist, which means that it blocks the effects of estrogen in the body.

It is administered through intramuscular injection, and its effectiveness is based on its ability to bind to and degrade the estrogen receptors on cancer cells. This degradation process weakens and eventually destroys the cancer cells, thus reducing the size of tumors and slowing the progression of the HR+ breast cancer.

It has been shown to be effective in numerous clinical trials, and is often used as an alternative to other endocrine therapies, such as aromatase inhibitors or tamoxifen. It is commonly used to treat advanced breast cancer that has spread to other parts of the body, as well as recurrent and metastatic breast cancer.

It is often used in combination with other cancer treatments, such as chemotherapy or targeted therapy. It is also sometimes used as a first-line therapy for women with advanced breast cancer, or as a second-line therapy after other treatments have failed.

In addition to its use in breast cancer treatment, it is also being investigated for its potential in treating other types of cancer, such as prostate cancer and ovarian cancer. It is a promising drug in the fight against hormone-dependent cancers, and is continuing to be studied and evaluated for its efficacy and safety.

Overall, it is a valuable medication in the treatment of hormone receptor-positive breast cancer, and has shown to have a significant impact on patient outcomes. Its use in combination with other therapies, or as a standalone treatment, is an important component in the fight against cancer.

 

Reference materials

Jiang Hang, Wang Tao, Zhang Shaohua, Du Meng, etc A clinical study on the treatment of recurrent and metastatic breast cancer with fluvastatin, which has been treated with aromatase inhibitors. CNKI; WanFang, 2013, Wang Jiayu, Yuan Peng, Ma Fei, Fan Ying, etc Efficacy and safety of Fluvastatin in the treatment of postmenopausal metastatic breast cancer. CNKI; WanFang, 2011

Yang Junlan, You Junhao, Han Chun, etc Observation on the efficacy of fluvison in the treatment of receptor positive advanced breast cancer. Journal of the PLA Medical College, 2013

Xiang Xiao, Wang Lumei, Zhong Lingying, and others The composite effect of environmental estrogens o, p '- DDT and anti estrogenic fluvastatin on zebrafish embryos. Journal of Ecotoxicology, 2012

Liu Ping, Bian Qiang Fulvestrant, a therapeutic drug for breast cancer, World Clinical Medicine, 2004.

 

Contact information

as a supplier of  Fulvestrant API , Xi'an Yihui has rich production experience and technical knowledge, high-quality products, flexible production capacity, and quality customer service, which can provide better support and service to customers.

if you need it, pls feel free to contact us any time. we will reply you asap.

Our contact information:

E-mail: sales@yihuipharm.com
Tel: 0086-29-89695240
WeChat or WhatsApp: 0086-17792415937

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