| CAS No.: | 129453-61-8 |
|---|---|
| Formula: | C32h47f5o3s |
| EINECS: | 642-998-6 |
| Type: | Pharmaceutical Intermediates |
| Appearance: | Powder |
| Quality: | Refined |
| Samples: |
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| Customization: |
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Audited Supplier Fluvestran is an intramuscular drug developed by AstraZeneca. It was approved by the US Food and Drug Administration in April 2002 and is applicable to the treatment of estrogen receptor positive metastatic breast cancer in postmenopausal women whose disease is still deteriorating after anti estrogen treatment. Many breast cancer cells have estrogen receptors (ER), which can stimulate the growth of such tumors. Fluvastatin is a "pure" estrogen receptor antagonist that does not have a partial estrogenic like agonist effect. It inhibits the estrogen signaling pathway by binding, chemically blocking, and downregulating ER, and can competitively bind with ER. Its affinity with ER is close to that of estrogen, 100 times that of tamoxifen. It is the only antiestrogen drug that can be widely used in clinical practice after tamoxifen's failure. As an endocrine therapy, this drug does not cause common adverse reactions to chemotherapy, so it has good patient compliance. A number of clinical studies have found that the 250 mg dose of fluoxetine has good therapeutic effect and stable safety in the second-line treatment of advanced breast cancer.
Tests |
SPECIFICATIONS | RESULTS |
Description |
White to off-white crystalline powder,no visible evidence of contamination by foreign material | White Crystalline Powder |
Color |
1% of API solution in ethanol (96%) must be colorless |
Conforms |
Clarity of the solution |
1% of AP| solution in ethanol (96%) must be clear |
Conforms |
Solubility |
Practieally insoluble in water,freely soluble in ethanol(96%)and in methylene chloride. | Conforms |
Identification |
IR absorption spectrum of the preparation of the test specimen exhibits maxima only at the same wavelengths as that of a similar preparation of the USP and/or in-hourse reference standard. | Conforms |
| The HPLC retention time of the sample preparation in the assay preparation corresponds to that of the USP and/or in-hourse reference standard. | Conforms | |
Water (Karl Fischer) |
Not more than 0.5% | 0.11% |
Residue on ignition |
Not more than 0.1% | <0.1% |
Residual solvents Ethyl acetate |
All the solvents conforms with ICH requirements Not more than 0.5% | Conforms 0.12% |
| Microbiology | TAMC-NMT 100 cfu/g (ml) |
Conforms |
| TYMC-NMT 10 cfu/g (ml) |
Conforms |
|
| Enterobacterias resistant to bile- absent in 1g/ml |
Conforms |
|
| Pseudomonas aeruginosa - absent in 1 g/ml |
Conforms |
|
| Absence of Staphylococcus aureus per 1 g or1 ml |
Conforms |
|
Bacterial endotoxins |
Not more than0.5 UE/mg | Conforms |
Heavy metals |
Not more than0.002% | <10ppm |
Specific rotation |
from +108.0°up to +115.09 | +112° |
Fulves trant isomer A |
42-48% | 44% |
Fulves trant isomer B |
52-58% | 56% |
6-kcto-fulves trant |
Not more than 0.1% | ND |
6,7-fulves trant |
Not more than 0.1% | ND |
Fulves trant sulfate |
Not more than 0.15% | ND |
Fulves trant extended |
Not more than 0.15% | ND |
Fulves trant steroldimer |
Not more than 0.15% | ND |
Unspecified impurities |
Not more than 0.10% | 0.06% |
Total impurities |
Not more than 1.0% | 0.2% |
Assay |
Fulves trant contains not less than 98.0% and not more than 102.0%calculated on theanhydrous basis. | 99.6% |
Conclusion |
The results conform to the Enterprise standard. |
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Jinan Hong Kongda Chemical Co., Ltd. is a high-tech enterprise specializing in the production of chemical raw materials and advanced pharmaceutical intermediates integrating scientific research, production and sales. The headquarter is located in Jinan, the capital of Shandong Province with major pharmaceutical province in China which has strong resource advantages.
The company has a complete production system with more than 150 sets of reaction equipment, covering production facilities for various special reactions such as high temperature, ultra-low temperature and hydrogenation. In order to continuously innovate and optimize the process, the company is equipped with an experienced R&D team, and established long-term and stable cooperative relations with many colleges and research institutes.
In order to optimize global resources, protect the environment, and make up for the shortage of some domestic chemical intermediates, the company has established a cooperation center in India to solve domestic shortages.
"Stable quality, price advantage" is our consistent service tenet, and has won a good reputation in the industry′s customer cooperation and service. We hope and look forward to cooperating with you in the future!
Q1 Can i get some samples
A1 Yes, we can supply the free sample, but the shipping cost be paid by our customers.
Q2 How to start orders or make payments
A2 Proforma invoice will be sent first after confirmation of order, enclosed our bank information. Payment by T/T
Q3 How to confirm the Product Quality before placing orders
A3 You can get free samples for some products,you only need to pay the shipping cost or arrange a courier to us and take the samples. You can send us your product specifications and requests, we will manufacture the products according to your requests.
Q4 What's your MOQ
A4 Our MOQ is 1kg. But usually we accept less quantity such as 100g on the condition that sample charge is 100% paid.
Q5 How about delivery leadtime
A5 Delivery lead time: About 3-5 days after payment confirmed. (Chinese holiday not included)
Q6 Is there a discount
A6 Different quantity has different discount.
Q7 How do you treat quality complaint
A7 First of all, our quality control will reduce the quality problem to near zero. If there is a real quality problem caused by us, we will send you free goods for replacement or refund your loss.
Q8 How to contact us
A9 You can chat with us by Trademanager,Skype, Wechat, Whatsapp Online.
You can choose your interested products and send inquiry to us.
You can dial our telephone directly or send Email to us., you will get our reply.
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