Complaint
Entecavir monohydrate is a new type of cyclovaleryl guanosine anti hepatitis B virus drug. Its pharmacological action is similar to that of Entecavir. It is clinically applicable to the treatment of chronic adult hepatitis B with active virus replication, continuous elevation of serum aminotransferase ALT, or liver histology showing active lesions.
| Test items | Acceptance criteria | Result | |
| Description | White to off-white powder | White powder | |
| Identification | 1)The IR absorption spectrum of the sample must be concordant with entecavir 2) RT of the sample should match that of standardin assay preparation | Conform Conform | |
| Water | 5.8%-6.5% | 6.2% | |
| Optical rotation | +24.0°-+28.0°(DMF:MeOH=1:1 c=1%) | +26.6° | |
| Residue on ignition | ≤0.1% | 0.09% | |
| Heavy metals | ≤20ppm | <20ppm | |
| Related Substances | Total impurities ≤0.3% Any individual impurity ≤0.1% | 0.12 0.02% | |
| Assay(HPLC) | 98.0% -102.0%( on anhydrous basis) | 100.0% | |
| Residual solvents | dic-hloromethane≤600ppm meth-anol≤3000ppm ethyl-acetate≤5000ppm tol-uene≤890ppm | not detected not detected not detected not detected | |
| Conclusion: conform | |||
Entecavir, a nucleoside analogue of guanine, has an inhibitory effect on hepatitis B virus (HBV) polymerase. It can be converted into active triphosphate through phosphorylation. The half-life of triphosphate in cells is 15 hours. The natural substrate competes with the deoxyguanosine triphosphate of HBV polymerase, and entecavir triphosphate can inhibit all three activities of viral polymerase (reverse transcriptase):
(1) HBV polymerase promoter;
(2) Before the formation of reverse transcriptional negative chain synthesis of genomic mRNA;
(3) HBV DNA is a strand.
Can be applied to:
Treat hepatitis B infection. Helps prevent hepatitis B virus from multiplying and infecting new hepatocytes. Entecavir is also used to treat chronic hepatitis B infected with HIV/AIDS in adults.
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SCM Pioneering Co., Ltd is an emerging supplier of high quality ingredients which based in Shandong province, China.
SCM was established by group of experts who have more than ten years experiences in pharmaceutical and food ingredients industries. with our deep knowledge and diligence, together with our associated plants, we would like to provide one-stop sourcing solutions for customers, to save your time and secure your purchasing.
1.What are the suitable populations for Entecavir monohydrate?
Entecavir monohydrate has obvious auxiliary effect on the treatment of chronic hepatitis B, and is mainly suitable for people with chronic hepatitis B.
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