99% up, DMF, FDA (zero defect) Emtricitabine 143491-57-0

Name: 99% up, DMF, FDA (zero defect) Emtricitabine 143491-57-0
Availability: 99-up-dmf-fda-zero-defect-emtricitabine-273800.html

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:99% up, DMF, FDA (zero defect) Emtricitabine 143491-57-0
CAS No.:143491-57-0
Standard:USP, BP, EP, JP, In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co.Ltd.

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Product Information

Product name	Emtricitabine
CAS No.	143491-57-0
Molecular Formula	C8H10FN3O3S
Molecular Weight	247.247
Quality Standard	98% up, Medicine Grade
Appearance	White powder

COA of Nonapeptide-1

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
Particle size by laser light scattering	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

Usage

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

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99% up, DMF, FDA (zero defect) Emtricitabine 143491-57-0

Product Information

Product name

Emtricitabine

CAS No.

143491-57-0

Molecular Formula

C8H10FN3O3S

Molecular Weight

247.247

Quality Standard

98% up, Medicine Grade

Appearance

White powder

COA of Nonapeptide-1

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)

Our advantages of Emtricitabine (CAS: 143491-57-0) :
1. Quality: 99% up, full test report.

4. Zidovudine USP
5. Lopinavir USP