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2023-11-01 12:42
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Company Profile
Xi'an Yihui Bio-technology Co., LtdBy certification [File Integrity]
Contact:yihuisw(Mr.)
Email:
Telephone:
Phone:
Area:Shaanxi
Address:Shaanxi
Website:http://www.yihuipharm.com/ http://yihuisw.hbkuang.com/
What is Entecavir hydrate?
Entecavir hydrate chemical name is (1S,4R)-2-Amino-1-[4-hydroxy-2-(hydroxymethyl) cyclopent-1-enyl]-6-(4-propyl-3-sulfonatopropoxy) quinazolin-4(3H)-one hydrochloride hydrate,The chemical formula is C12H15N5O3·H2O, CAS number is 209216-23-9. It is a broad-spectrum antiviral drug, belonging to nucleoside reverse transcriptase inhibitors. It is primarily used to treat hepatitis B virus (HBV) infection, but can also be used to treat viral diseases such as hepatitis C virus (HCV) infection.
The preparation method of Entecavir monohydrate is mainly divided into three steps:
Firstly, isopentane is used as solvent to react Entecavir hydrate API with sodium hydroxide to get intermediates;
The intermediate was further reacted with tert-butoxycarbonyl isopropyl carpofunate in N, n-dimethylformamide (DMF) to form a product;
3. The product was crystallized, filtered and dried to obtain Entecavir monohydrate with high purity and stable quality. The preparation method can improve the yield and purity, and is simple to operate and has good technological properties.
It is available in tablet or capsule form. In clinical use, Entecavir monohydrate can reduce symptoms of liver disease, improve liver function, and inhibit viral replication and infection.
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Basic Information:
Appearance |
White or off-white powder |
Melting point |
>220°C |
Structural formula |
CAS NO. |
209216-23-9 |
Boiling point |
501.14°C (rough estimate) |
|
MF |
C12H15N5O3·H2O |
Density |
1.81 |
|
MW |
295.3 |
refractive index |
D +35.0° (c = 0.38 in water) |
|
EINECS |
606-668-5 |
solubility Soluble |
DMSO (Slightly), Methanol (Sparingly), Water (Slightly, Heated, Sonicated) Â |
|
Assay |
min99% |
storage temp. |
2-8°C |
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Quality standard:
ITEMS |
SPECIFICATIONS |
Appearance |
White or off-white powder |
Specific Optical Rotation |
[a]25D , + 24.0°~+ 28.0° |
Identification |
HPLC: The retention time of the major peak of the test solution |
should correspond to that of the comparison solution . |
|
Sulfated Ash |
≤ 0.10% |
Related Substance ETA |
≤0.10% |
Related Substance |
G≤0.10% |
ET-1≤0.10% |
|
ET-2≤0.10% |
|
ET-3≤0.10% |
|
Individual unknown impurity≤0.10% |
|
Total impurities other than Related substance ETA , ET-4 ≤ 0.30% |
|
Related Substance ETA - 4 |
≤ 0.30% |
Residue Solvents |
Methanol≤600 ppm |
Dichloromethane≤300 ppm |
|
Ethyl Acetate≤5000 ppm |
|
Tetrahydrofuran≤720 ppm |
|
Water |
5.8%~6.5% |
Heavy Metals |
≤10 ppm |
Assay |
98.0%~102.0% (On Dry Basis) |
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Entecavir hydrate is a pharmaceutical raw materials used to treat hepatitis B virus (HBV) infection. its efficacy and application:
In summary, It is an effective medication for the treatment of hepatitis B virus infection, with the benefits of antiviral action, improvement of liver function, control of virus recurrence, and reduction of the risk of liver cirrhosis and liver cancer development. However, its specific application scope should be determined based on individual patient conditions and medical professional advice. Please consult a doctor or other healthcare institution before use.
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Important:
Please note that 'this product is a raw material for commercial use only, not personal consumption'. Our company will not be responsible for any risks or consequences caused by personal use.
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Packing:
1~2kg |
|
2-10kg |
|
10-25kg |
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Shipping:
≤50kg |
By express door to door Fedex, DHL,UPS,TNT,EMS ect. Fast and convenient |
|
50kg~200kg |
By air Fast and cheap |
|
≥200kg |
By sea Cheapest way |
|
Or as your requirement to choose the cheapest way or the fast. |
Xi 'an Yihui company’s sales office, production equipment
Xi’an Yihui Company has High level of research and development ability
Xi 'an Yihui Company’s Advanced production equipment and technology
Perfect after-sales service
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Entecavir API, produced by Xi'an Yihui, has the following competitive advantages:
High purity and quality: Xi'an Yihui uses advanced production processes and equipment to strictly control every aspect of the product, ensuring high purity and quality. it produced in the GMP workshop, in accordance with international standards and regulations.
Price advantage: While maintaining high quality, our prices are relatively cheap. it can meet the needs of small and medium-sized pharmaceutical enterprises
Good stability: it has good stability, can be stored for a long time without easy decomposition or oxidation. Therefore, its variability is small during production and transportation, maintaining a longer effective period.
High safety: Through multiple clinical trials, it has been proven that Entecavir has good drug safety and tolerance, without damaging the liver or kidneys. At the same time, the drug has fewer side effects, increasing patient safety and comfort.
High-quality service: Xi'an Yihui has professional technical personnel and a complete after-sales service system, providing customers with comprehensive technical support and consultation services, ensuring that customers can use the product smoothly and achieve the best results.
In summary, Entecavir hydrate produced by Xi'an Yihui has the competitive advantages of high purity, high quality, price advantage, good stability, high safety, and high-quality service, making it an excellent choice for customers.
http://www.yihuipharm.com/