86-29-85733402
Room 11704, Zizhu Building, No. 108, West Section Of South 2nd Ring, Xi'an, Shaanxi, China (Mainland)
| Products: | Entecavir Monohydrate |
| Synonyms: | 2-Amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl] -6H-purin-6-one monohydrate |
| CAS#: | 209216-23-9 |
| Molecular Formula: | C12H17N5O4 |
| Molecular Weight: | 295.30 |
| Specification: | Assay≥99.7% |
| Molecular Structure: |  |
Specification of High quality Entecavir monohydrate:
Items | Specifications | Results |
[Description ] |
It should be white or whitish crystalline powder, odorless and tasteless, very slightly in water, slightly soluble in methanol and insoluble in ether.
| It is white crystalline powder, odorless and tasteless, very slightly in water, slightly in methanol and insoluble in ether. |
Specific rotation | Should be between +24°~+28° | +27° |
[Identification] |
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(1) HPLC | Retention time of the principal peak obtained from the test solution should be identical with that of the reference solution. | Retention time of the principal peal of Entecavir samples is identical with that of the reference standard. |
(2) IR | IR spectrum of samples should be identical with that of the reference standard. | IR spectrum of samples is identical with that of the reference standard. |
[Test] |
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pH | Should be between 5.5~7.5 | 6.0 |
Related substances |
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(1)Total impurity | Should be 0.3%max | 0.10% |
(2)maximum single impurity | Should be 0.1%max | 0.03% |
Enantiomer | Should be 0.2%max | 0.01% |
Methanol | Should be 0.3%max | Undetected |
Dichloromethane | Should be 0.06%max | Undetected |
N- hexane | Should be 0.029%max | Undetected |
Tetrahydrofuran | Should be 0.072%max | Undetected |
N,N-dimethylformamide | Should be 0.088%max | Undetected |
Toluene | Should be 0.089%max | Undetected |
Water | Should be between 5.8%~6.5% | 6.3% |
Residue on ignition | Should be 0.1%max | 0.0% |
Heavy metal | Should be 20ppmmax | Complies |
Assay | 98.0%~102.0%(C12H15N5O3) calculated on anhydrous basis | 100.1% |
Storage: Keep in well-closed containers, and at the temperature below 25°C.
Supply capability: 30kg/Year
Application of Entecavir monohydrate: Anti-infection,anti-virus,can used in the treatment of hepatitis B infection
Shaanxi Top Pharm Chemical Co., Ltd. has been primarily engaged in the research, development, and marketing of various photochemical products since 1999. We take full advantages of natural pharmaceutical resources .
TOP Pharm Chemical's Advantage:
(1) 10 years membership of ALIBABA. ----- Onsite check and Supplier assessment
(2) Certified by ISO9001:2008, SGS and Bureau Veritas.
(3) History: Established in 1999.
(4) Manufacturer direct supply, provide OEM, R&D service
Quality Guarantee:
Because herbal extract products are enterprise standard, always we will send typical samples (usually 20g) for your testing by FEDEX/DHL/EMS.
** If the quality is confirmed by you, we insist on batch sample confirmation after your commercial order.
** If your testing result is different from us. We hope to exchange and unify the testing mothod, until the quality is confirmed by you. We also insist on batch sample confirmation after your commercial order.
Suggestion:
Please kindly check the packages after you receive the goods, if you got wrong products/ quality problem/ short quantity, please get back to us as priority. Please note that you need to send us pictures of the defective items concerning this, and we will consider to replace or refund accordingly.
