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129453-61-8 Breast Cancer Drug Anticancer Drugs Steroidal Anti

Minimum Order Quantity : 100g Price : to be negotiated
Packaging Details : Inner package: double PE bag. Out package: 1-3kg in a Aluminum Tin Delivery Time : 25 days
Payment Terms : T/T, L/C Supply Ability : 100kg per year
Place of Origin: China Brand Name: LIBANG
Certification: Chinese GMP and Written Confirmation for Exporting to EU

Detail Information

Pharmacological Class: Receptor Antagonists Dossier: DMF Avail
Batch Size: 3.0kg Storage: Store At 2~8℃
Certi: WC Pack: Double PE Bag
High Light:

129453-61-8 Breast Cancer Drug

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129453-61-8 Anticancer Drugs

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Anticancer Drugs Steroidal Anti

Product Description

 

                                                   Fulvestrant CAS No.129453-61-8 Anti-Cancer Drug Substance

 

Fulvestrant is a steroidal anti that is used in the treatment of hormone-receptor positive metastatic breast cancer.

Xi'an Libang Pharmaceutical Co..Ltd developed Fulvestrant  API since 2007 and filed the DMF in US FDA in 2009.

The Fulvestrant API has been exported to USA, Argentina, Brazil, Russia, Pakistan and India.

 

Breast cancer
Fulvestrant is used for the treatment of hormone receptor positive metastatic breast cancer or locally advanced unresectable disease in postmenopausal women; it is given by injection.A 2017 Cochrane review found it is as safe and effective as first line or second line endocrine therapy.

It is also used to treat ER-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after first-line endocrine therapy.

Due to the medication's having a chemical structure similar to that of , it can interact with immunoassays for blood estradiol concentrations and show falsely elevated results.This can improperly lead to discontinuing the treatment.

 

TEST SPECIFICATION
Character White powder,freely soluble in alcohol(95%).
Foreign Matter-IH

The sample should be essentially free from black particles

and foreign matter that can be observed on visual inspection.

Identification A: IR Consistent with spectrum of standard reference.

 

Identification B:

 

The retention time of the major peak in the chromatogram of the assay preaparation corresponds to that of the standard preparation.
Water Not more than 0.5%
Related Compounds  
6-Keto-fulvestrant Not more than 0.10%
Δ6,7-Fulvestrant Not more than 0.10%
Fulvestrant sulfone Not more than 0.15%
Fulvestrant extended Not more than 0.15%
Fulvestrant sterol dimer Not more than 0.15%

Any individual unspecified

maximum impurity

Not more than 0.10%
Total Impurities Not more than 1.0%
Ratio of Isomers  
Fulvestrant A 42.0%-48.0%
Fulvestrant B 52.0%-58.0%
Residue of Solvents  
Tetrahydrofuran Not more than 720ppm
Ethyl Acetate Not more than 5000ppm
Dichloromethane Not more than 600ppm
n-hexane Not more than 290ppm
Ethanol Not more than 5000ppm

Acetic acid

 

Not more than 5000ppm

Ethyl

 

Not more than 5000ppm
Heavy metals Not more than 0.001%
Residue on ignition Not more than 0.1%
Specific rotation 108-115 at 365nm
Assay 98%~102.0%

 

 

Xi'an Libang Pharmaceutical Co., Ltd. was established in 1996, It is a professional Manufacture specializing in pharmaceutical raw materials and Finished dosage form. The company has gathered a dedicated and professional sales and technical personnel. We have a marketing team with first-class efficiency and first-class service! Strong technical force, high quality and low price products, first-class marketing and after-sales service are your best choice!

 

 

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