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| Brand Name: | LIBANG |
| MOQ: | 150g |
| Price: | to be negotiated |
| Payment Terms: | T/T, L/C |
| Supply Ability: | 15 kg one month |
CAS No.129453-61-8 Anti-Cancer Drug Substance
Pharmacodynamics
Fulvestrant is an anti which acts as an antagonist of the receptor (ER) and additionally as a selective receptor degrader (SERD). It works by binding to the receptor and making it more hydrophobic, which makes the receptor unstable and misfold, which in turn leads normal processes inside the cell to degrade it.
In addition to its antiic activity, fulvestrant is an agonist of the G protein-coupled receptor (GPER), albeit with relatively low affinity (10–100 nM, relative to 3–6 nM for estradiol).
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
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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% | |
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.
