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White Powder Fulvestrant DMF Pharma Intermediates For Vasodilator

Minimum Order Quantity : 150g 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 : 15 kg one month
Place of Origin: China Brand Name: LIBANG
Certification: Chinese GMP and WC

Detail Information

Usage: Vasodilator Purity: 99%
Colour: White BSE /TSE: NA
Certi: WC Pack: Double PE Bag
High Light:

White Powder Fulvestrant

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Powder Fulvestrant DMF

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Pharma Intermediates For Vasodilator

Product Description

 

Fulvestrant Anti-Cancer Drug Substance

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.

 

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.

 

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%

 

 

Who we are:

 

XI’AN LIBANG PHARMACEUTICAL CO.,LTD. founded in 1996 with a location in Xi’an City of China, the center of the northwest pharmaceutical industry, is specialized in research, development, production and distribution of specialty pharmaceutical products. As the first and also largest supplier of generic Propofol in China, LIBANG started its business and subsequently launched a broad portfolio finished dosage forms covering s, cardiovascular, antineoplastic, clinical nutrition etc.

With more than 20 years growth, LIBANG has transformed into an integrated health care solution provider, LIBANG HEALTHCARE GROUP, with diversified fields covering high value-added APIs, pharmaceutical excipients, prescription drugs, OTC products, biomedicine, medical devices.

LIBANG is a technology-driven firm, with more than 8% of the annual sales revenues devoted to research and innovation, establishing a unique R&D platform to proactively follow the latest pharmaceutical technology frontier.

LIBANG now is one of Top 100 China’s Pharmaceutical Industries and also listed in the Top 20 The Most Potential Chinese Pharmaceuticals that was rated by the IMS Health.

 

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+8618089290889