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Entecavir 142217-69-4 Entecavir 142217-69-4

Entecavir 142217-69-4
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Maklumat asas Entecavir

Name

Entecavir

Alias

 ETV

CAS NO.

142217-69-4

Molecular Formula

C12H15N5O3

Molecular Weight

277.283

Quality Standard

96% min

Grade Standard

Food grade, Medicine grade

Package Size

25kg/drum

Penggunaan Entecavir

Entecavir ditunjukkan untuk rawatan hepatitis B dewasa kronik dengan replikasi virus aktif, serum aminotransferase ALT yang tinggi, atau histologi hati yang menunjukkan penyakit aktif.

COA Entecavir

Items

Specification

Results

Appearance

A white to nearly white crystalline powder, odorless.

Nearly white crystalline powder, odorless.

Solubility

Very slightly soluble in water, slightly soluble in methanol, practically insoluble in aether.

Very slightly soluble in water, slightly soluble in methanol, insoluble in aether.

Specific rotation

+24°~+28°

+27°



Identification

1.The retention time of the principle peak obtained from the test solution is identical with that obtained from reference solution.

The retention time of the principle peak obtained from the test solution is identical with that obtained from reference solution.

2.The infrared absorption spectrum is identical with that of reference.

The infrared absorption spectrum is identical with that of reference.

PH

5.5~7.5

6.1

Related substances

1.Single largest unknown≤0.10%

0.03%

2.Total impurities≤0.30%

0.16%

Enantiomers

≤0.2%

Not detected

Methanol

≤0.3%

Not detected

Dichloromethane

≤0.06%

Not detected

n-Hexane

≤0.029%

Not detected

Tetrahydrofuran

≤0.072%

Not detected

N,N-dimethylformamide

≤0.088%

Not detected

Toluene

≤0.089%

Not detected

Water

5.8%~6.5%

6.3%

Residual on ignition

≤0.1%

0.02%

Heavy metal

≤20ppm

Complies

Assay

98.0%~102.0%(C12H15N5O3, on anhydrous basis)

99.9%

Conclusion

The resultsconform to theStandard


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MORE_DETAIL Entecavir 142217-69-4

Maklumat asas Entecavir

Name

Entecavir

Alias

 ETV

CAS NO.

142217-69-4

Molecular Formula

C12H15N5O3

Molecular Weight

277.283

Quality Standard

96% min

Grade Standard

Food grade, Medicine grade

Package Size

25kg/drum

Penggunaan Entecavir

Entecavir ditunjukkan untuk rawatan hepatitis B dewasa kronik dengan replikasi virus aktif, serum aminotransferase ALT yang tinggi, atau histologi hati yang menunjukkan penyakit aktif.

COA Entecavir

Items

Specification

Results

Appearance

A white to nearly white crystalline powder, odorless.

Nearly white crystalline powder, odorless.

Solubility

Very slightly soluble in water, slightly soluble in methanol, practically insoluble in aether.

Very slightly soluble in water, slightly soluble in methanol, insoluble in aether.

Specific rotation

+24°~+28°

+27°



Identification

1.The retention time of the principle peak obtained from the test solution is identical with that obtained from reference solution.

The retention time of the principle peak obtained from the test solution is identical with that obtained from reference solution.

2.The infrared absorption spectrum is identical with that of reference.

The infrared absorption spectrum is identical with that of reference.

PH

5.5~7.5

6.1

Related substances

1.Single largest unknown≤0.10%

0.03%

2.Total impurities≤0.30%

0.16%

Enantiomers

≤0.2%

Not detected

Methanol

≤0.3%

Not detected

Dichloromethane

≤0.06%

Not detected

n-Hexane

≤0.029%

Not detected

Tetrahydrofuran

≤0.072%

Not detected

N,N-dimethylformamide

≤0.088%

Not detected

Toluene

≤0.089%

Not detected

Water

5.8%~6.5%

6.3%

Residual on ignition

≤0.1%

0.02%

Heavy metal

≤20ppm

Complies

Assay

98.0%~102.0%(C12H15N5O3, on anhydrous basis)

99.9%

Conclusion

The resultsconform to theStandard

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