31618-90-3 Tenofovir intermediates factory

ITEM

SPECIFICATIONS

RESULTS

APPEARANCE

White to off white crystalline powder

White crystalline powder

SOLUBILITY

Slightly soluble in water,soluble in methanol,sparingly soluble in acetone,practically insoluble in methylene chloride

Conforms

IDENTIFICATION

The IR spectrum is concordant with the reference standard.

The retention time of the main peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard prepraration,obtained as directed in the Assay

Conforms

Impurity G

NMT 0.15%

None detected

Impurity A

NMT 1.0%

0.03%

Impurity B

NMT 5 PPM

None detected

RELATED SUBSTANCES(HPLC)

Impurity C:NMT 1.0%

Impurity E:NMT 0.15%

Any individual impurity:NMT 0.10%

Total impurities:NMT 1.5%

0.41%

0.09%

0.06%

0.62%

RESIDUAL SOLVENTS(GC)

Test one:

Ethanol:NMT 5000ppm

Isopropyl:NMT 5000ppm

Isopropyl acetate:NMT 5000ppm

Dichloromethane:NMT 600ppm

Test two:

N,N-dimethylformamide:NMT 880 ppm

N-Methylpyrrolidone:NMT 530 ppm

None detected

None detected

None detected

None detected

None detected

277ppm

WATER(KF)

NMT 1.0%

0.7%

HEAVY METALS

NMT 20 ppm

<20ppm

FUMARIC ACID(BY HPLC)

17.5%~19.0%(anhydrous substance)

18.6%

ASSAY

NLT 98.0% & NMT 102.0%,(anhydrous substance)

100.1%

STORAGE

Preserved in tight containers, and stored between 2℃-8℃

Conclusion: Quality comply with the specification of In house.