Entecavir Monohydrate CAS 209216-23-9 API Factory High Quality Antiviral Hepatitis B Infection
Manufacturer Supply with High Purity and Stable Quality
Chemical Name: Entecavir Monohydrate
CAS: 209216-23-9
Used in the treatment of Hepatitis B Infection
API High Quality, Commercial Production
Chemical Name | Entecavir Monohydrate |
Synonyms | Entecavir Hydrate; 9-[(1S,3R,4S)-4-Hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]guanine Monohydrate |
CAS Number | 209216-23-9 |
CAT Number | RF-API79 |
Stock Status | In Stock, Production Scale Up to Hundreds of Kilograms |
Molecular Formula | C12H17N5O4 |
Molecular Weight | 295.3 |
Melting Point | >220℃ |
Density | 1.81 |
Shipping Condition | Shipped Under Ambient Temperature |
Brand | Ruifu Chemical |
Item | Specifications |
Appearance | White or Almost White Crystalline Powder |
Solubility | Freely Soluble in Dimethylformamide, Slightly Soluble in Water, Ethanol and Methanol |
Identification IR | Spectrum of the sample corresponds to that of reference standard |
Identification HPLC | The retention time of the test sample corresponds to that of the reference standard |
Water Content (by K.F) | 5.5%~6.5% |
Specific Optical Rotation | +24.0° to +30.0° (DMF: MeOH=1:1 C=1%) (on anhydrous substance) |
Residue on Ignition | ≤0.10% |
Related Substances | |
Furoentecavir | ≤0.10% |
Entecavir 1-Epimer | ≤0.10% |
Entecavir 3-Epimer | ≤0.10% |
8-Methyoxy Entecavir | ≤0.10% |
Entecavir 4-Epimer | ≤0.10% |
8-Hydroxy Entecavir | ≤0.10% |
4-Dimethylsilyl Entecavir | ≤0.10% |
Entecavir Related Compound A | ≤0.10% |
Any Unspecified Impurity | ≤0.10% |
Total Impurities | ≤0.30% |
Residual Solvents | |
Methanol | ≤600ppm |
Dichloromethane | ≤300ppm |
Ethyl Acetate | ≤1000ppm |
Tetrahydrofuran | ≤720ppm |
Toluene | ≤890ppm |
Benzyl Chloride | ≤1000ppm |
Benzyl Alcohol | ≤1000ppm |
Microbial Limit | |
Total Aerobic Counts | ≤100cfu/g |
Yeasts and Molds | ≤10cfu/g |
Escherichia Coli | Should Not Detected |
Heavy Metals | ≤10ppm |
Assay | 98.0%~102.0% (HPLC; on the anhydrous basis) |
Particle Size | 95% of the particles should be within 125um |
Test Standard | Enterprise Standard; United States Pharmacopoeia (USP) Standard |
Usage | Antiviral drug used in the treatment of Hepatitis B Infection |
Package: Bottle, Aluminum foil bag, Cardboard drum, 25kg/Drum, or according to customer's requirement.
Storage Condition: Store in sealed containers at cool and dry place; Protect from light, moisture and pest infestation.
Entecavir Monohydrate (CAS 209216-23-9) is an oral antiviral drug used in the treatment of Hepatitis B Virus (HBV) infection. Entecavir Monohydrate is a nucleoside analog (more specifically, a guanine analogue) that inhibits reverse transcription, DNA replication and transcription in the vira. It is a new kind of cyclopentyl acyl guanosine anti-Hepatitis B virus drugs with its pharmacological effects similar as Entecavir. It is clinically applied to the treatment of adult Chronic Hepatitis B in which there is active viral replication, increased serum transaminase ALT or active lesions showed from liver histology. Entecavir Monohydrate is a potent and selective inhibitor of HBV, with an EC50 of 3.75 nM in HepG2 cell. Entecavir is a reverse transcriptase inhibitor. It prevents the Hepatitis B Virus (HBV) from multiplying and reduces the amount of virus in the body.