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Items |
Specifications |
Results |
Appearance |
White to off-white powder |
White powder |
Solubility |
Freely solution in methanol and in ethanol, soluble in 2-propanol |
Conforms |
Identification |
HPLC: the retention time of the test sample corresponds to that of the reference standard
IR: the infrared absorption spectrum of the test sample is concordant with the spectrum of reference standard |
Conforms
Conforms |
Water content by KF |
NMT 0.5% |
0.06% |
Specific optical rotation |
+7.0°~+10.5°(c=2 in MeOH) |
+10.21° |
Residue on ignition |
NMT 0.2% |
0.10% |
Heavy metals |
NMT 20 ppm |
Conforms |
Sulphated ash |
NMT 0.105 |
0.03% |
Organic volatile impurities |
Ethylacetate: NMT 0.5% Heptane: NMT 0.5% Tetrahydrofuran: NMT 0.072% |
0.40% 0.16% ND |
Related substances (by HPLC, area%) |
Impurity E (RRT=0.36):NMT 0.3% ImpurityO(RRT=1.11):NMT 0.3% Impurity T (RRT=2.87):NMT 0.2% Any other individual impurity: NMT 0.1% Total impourities: NMT1.0% |
0.08% ND ND Conforms 0.16% |
Assay (by HPLC) |
98.0%~102.0% |
99.0% |
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