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 | Packaging Details : | Inner package: double PE bag. Out package: 1-3kg in a Aluminum Tin |
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| Delivery Time : | 30 days | Payment Terms : | T/T, L/C |
| 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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| Quality Specification: | USP | Dossier: | DMF Available |
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| Batch Size: | Approx. 3kg | Storage: | Store At 2~8℃ |
| Cert: | WC | Origin: | China |
| High Light: | DMF Fulvestrant API,Fulvestrant API USP 129453-61-8,129453-61-8 Breast Cancer Medication |
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Product Description
Fulvestrant API USP CAS No.129453-61-8 Anti-Cancer Drug Substance
Common Name: Fulvestrant
Manufacturer: Xian Libang Pharmaceutical Co., Ltd.
Mailing Address: No. 42, Fengchan West Road, Weiyang District, Xian, China 710086
Note to Physicians
Overdose Treatment: For current information about the treatment of overdose, consult a certified Regional Poison Control Center by
The quality of this API is featured as follow:
| 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:
|
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 | |
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Acetic acid
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Not more than 5000ppm | |
|
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% | |
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.
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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 |