Steroidal Antiestrogen Fulvestrant Anti Cancer Drug WC Avai 129453-61-8
Contact Person : Jimmy Tian
Phone Number : 86-18602905046
WhatsApp : +8618602905046
| Minimum Order Quantity : | 100g | Price : | to be negotiated |
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| Packaging Details : | Inner package: double PE bag. Out package: 1-3kg in a Aluminum Tin | Delivery Time : | 25 days |
| Payment Terms : | T/T in advance | Supply Ability : | 100kg per year |
| Place of Origin: | China | Brand Name: | LIBANG |
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| Certification: | Chinese GMP and Written Confirmation for Exporting to EU |
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Detail Information |
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| Cas No.: | 129453-61-8 | Cert.: | US FDA In 2009 |
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| Batch Size: | Approx. 3kg | Storage: | Store At 2~8℃ |
| Certi: | WC | Pack: | Double PE Bag |
| High Light: | Api Faslodex,Api 129453-61-8,Faslodex for Hormone Receptor Positive Metastatic Breast Cancer |
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Product Description
Fulvestrant
Fulvestrant is a steroidal antiestrogen 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.
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!
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 estrogen, 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. | |
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Identification B:
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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% | |
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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 | |
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Acetic acid
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Not more than 5000ppm | |
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Ethyl ether
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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% | |
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| Xi'an Libang Pharmaceutical Co., Ltd. |
| 17/F, Block E, Wangzuo International Plaza, No.1, Tangyan Road, Xi’an Hi-tech Zone, Shaanxi, P.R.China 710075 |
| 86-29-89527363 |
| jiangping@libang.com.cn |