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.

 

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

 

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)

 

Entecavir hydrate is a pharmaceutical raw materials used to treat hepatitis B virus (HBV) infection. its efficacy and application:

• Antiviral action: It is a nucleoside analogue that can inhibit the replication and spread of the hepatitis B virus. It works by suppressing the activity of the virus's reverse transcriptase, preventing the replication of the viral genome, thereby reducing the viral load and inhibiting viral replication.
• Improves liver function: Treatment with entecavir can effectively improve liver function markers such as hepatitis B virus serology markers (HBsAg, HBeAg), and liver enzymes (ALT, AST) levels. It can alleviate liver inflammation and prevent further liver damage.
• Controls virus recurrence: It can suppress the recurrence of hepatitis B virus. Long-term use can help maintain sustained suppression of hepatitis B virus DNA, reducing viral replication and the risk of hepatitis B virus resistance.
• Reduces the risk of liver cirrhosis and liver cancer development: Treatment with entecavir can reduce the risk of progression to liver cirrhosis and liver cancer in individuals infected with hepatitis B virus. By inhibiting viral replication, it can slow down the progression of virus-related liver disease, thereby reducing the occurrence of liver cirrhosis and liver cancer.
• Application scope: It is suitable for the treatment of chronic hepatitis B virus infection in adults. It can also be used in certain special cases, such as pediatric hepatitis B virus infection, pregnant women with hepatitis B virus infection, or in the case of hepatitis B virus drug resistance. However, it should be used under the guidance of a doctor.

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.

 

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.

 

 

Packing：

1~2kg
2-10kg
10-25kg

 

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.

 

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/