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| Brand Name: | LIBANG |
| MOQ: | 50g |
| Price: | to be negotiated |
| Payment Terms: | T/T, L/C |
| Supply Ability: | 15 kg one month |
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.
Fulvestrant, sold under the brand name Faslodex among others, is a medication used to treat hormone receptor (HR)-positive metastatic breast cancer in postmenopausal women with disease progression as well as HR-positive, HER2-negative advanced breast cancer in combination with palbociclib in women with disease progression after endocrine therapy. It is given by injection into a muscle.
Fulvestrant is a selective receptor degrader (SERD) and was first-in-class to be approved. It works by binding to the receptor and destabilizing it, causing the cell's normal protein degradation processes to destroy it.
| 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
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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 developed Fulvestrant API since 2007 and filed the DMF in US FDA in 2009.
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!
