Tenofovir Alafenamide Hemifumarate
Synonym:
GS-7340 Hemifumarate;
Tenofovir alafenamide fumarate, 2:1;
(E)-but-2-enedioic acid,propan-2-yl (2S)-2-[[1-(6-aminopurin-9-yl)propan-2-yloxymethyl-
phenoxyphosphoryl]amino]propanoate;
L-Alanine,N-((S)-(((1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy)methyl)phenoxyphosphinyl)-,1-methylethyl ester,(2E)-2-butenedioate (2:1);
GS-7340-03;
CAS no:1392275-56-7
Molecular formula:C46H62N12O14P2
Molecular weight:1069.00000
PSA:381.18000
LogP:7.60180
ITEM OF ANALYSIS
STANDARD
Description
White to off-white or
tan powder
Identification
IR: The IR absorption
spectrum of the sample must be concordant with Test Standard
HPLC: The retention time
of the major peak in the chromatogram conforms to the characteristic peak of
R.S
Melting point
128℃~134℃
Water
≤1.0%
Fumaric acid
9.0%-13.0%
Heavy Metals
≤20ppm
Related substances
Single impurity≤0.2%
Total impurities≤1.0%
Isomer sum
≤0.5%
Residue Solvents
Meets current ICH
requirements
Assay
98.0%~102.0%
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