Chemical Properties:
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.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| 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 |
Description:
Specifications:
Package & Storage:
| 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 |
Advantages:
FAQ:
Application:
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.
