Potassium Sodium Dehydroandroandrographolide Succinate
Product name 14-Dehydroxyl- 11,12-Dehydroandrographolide -3,19- Succinate Potassium
Sodium Monohydrate
Structure
Molecular Formula C28H34KNaO10·nH2O
Molecular Weight n=0 592.66 n=1 610.68
CAS Number
NMPA approval No. H20057578
National Drug Standards YBH25612005 Draft Quality Standards for Comments(2016)
|
Test |
CP |
Results |
|
Color & Appearance |
White to yellowish powder Orcrystalline powder |
White powder |
|
Assay ( HPLC )(calculated by anhydrous substance) |
98%～102% |
99.1% |
|
Impurities (total) Unkown Impurities(individual) |
NMT 2.0 % NMT1.0% |
0.3% 0.08% |
|
pH |
6.0～7.5 |
6.6 |
|
Loss on Drying |
NMT 4.0 % |
0.9% |
|
Heavy metals (as Pb) Residual Solvents(acetone ) Bacterial endotoxin |
NMT 10 ppm NMT 0.5% LT 0.25EU/mg |
Conforms Conforms Conforms
|
Package: 1kg
Storage ：Preserve in tight, containers ,store at temperature blow 20℃.