Product name | Emtricitabine |
CAS No. | 143491-57-0 |
Molecular Formula | C8H10FN3O3S |
Molecular Weight | 247.247 |
Quality Standard | 98% up, Medicine Grade |
Appearance | White powder |
TEST | SPECIFICATION | RESULTS |
Appearance | White to off-white powder | White powder |
Identification | By chiral HPLC: the retention time of the main peak corresponds within 2.0% to that of the cis-(-)-EMTB reference standard | < 0.1% Conforms |
| By IR: Consistent with the reference standard | Conforms |
Clarity of solution (1% w/v in water) | Clear, essentially free of visible particles | Conforms |
Water Content | NMT 0.5% | < 0.1% |
Heavy Metals as lead | NMT 20 ppm | < 10 ppm |
Residue on ignition | NMT 0.2% | 0.1% |
Bulk density | Report data | 0.20 g/mL |
Particle size by laser light scattering | d50 ≤ 30 | 24 |
d90: 45~75 | 51 |
Residual solvent | Methanol ≤ 0.20% | ND |
Isopropyl acetate ≤ 0.20% | ND |
l-propanol ≤ 1.00% | 0.05 |
Any unspecified solvent ≤ 0.10 or ≤ the premitted daily exposure specified by ICH Q3C | ND |
EMTB-Dioxolane | ≤ 0.70% | ND |
EMTB-Carboxylic acid | ≤ 0.50% | ND |
EMTB-Disulfide | ≤ 0.30% | ND |
Emtb sulfoxides | ≤ 0.15% | 0.05% |
Any unspecified impurity by HPLC | ≤ 0.10% | Trace |
Total impurities by | ≤ 1.0% | 0.1% |
Assay by HPLC | 98.0~102.0 (Dried basis) | 100.1 |
98.0~102.0 (Anhydrous basis) | 100.1 |
Drug content factor(Report data) | 0.999 |
cis-(-)chiral purity by HPLC(%) | cis-(-)-EMTB ≥ 98.5 | 100.0 |
cis-(+)-EMTB (report data) | Trace |
trans-(-)-EMTB (report data) | ND |
trans-(+)-EMTB (report data) | ND |
CONCLUSION | LOT MEETS SPECIFICATION |
Function of Emtricitabine
Emtricitabine is a new type of nucleoside reverse transcriptase inhibitor that has antiviral activity against HIV-1, HIV-2 and HBV. This product is phosphorylated into cellular active 5'-triphosphate after oral administration. The 5'-triphosphate enters the viral DNA backbone and binds to the backbone, resulting in chain termination, thereby inhibiting HIV-1 reverse transcriptase and HBV DNA polymerase activity.
Emtricitabine does not affect the liver microsomal enzyme P450 enzyme system, and does not produce drug interactions mediated by it. It is used in combination with tenofovir, indinavir, famciclovir, and stanvudine, with almost no pharmacokinetics influences.
Our advantages of Emtricitabine (CAS: 143491-57-0) :
1. Quality: 99% up, full test report.
2. Documents: DMF, our facotory pass FDA audit with Zero defect. passing MCC in South African,
3. Large capacity & stock :80MT per year with 1000kg in stock for prompt shipment
4. Better payment terms : We can make use of Export Credit Insurance after confirming yr credit report accepted by Sinosure.
5. Various shipping ways for your choice : by air./ by sea / by courier (DHL/FedEx).
6. we also provide TDF, TAF, Efavirenz, that used togher with Emtritabine as the Compound Preparation to treat HIV.
The main Compound Preparation:
TDF+Emtricitabine and TDF+Emtricitabine+Efavirenz.
Other anti-virus products.
1. Oseltamivir phosphate 99%
2. Tenofivir Disoproxil Fumarate 99%
3. Lamivudine USP
4. Zidovudine USP
5. Lopinavir USP
6. Ritonavir USP
7. Remdesivir USP
8. Abacavir sulfate USP
9. Efavirenz
10. TAF
