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Срок поставки: | 2 дней |
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Модель: PH-XXG-14
Item |
Requirements |
Test Results |
|
characters |
white or yellowish amorphous powder, smellless, tasted sweet, hygroscopic .very soluble in water, soluble in methanol, practically insoluble in methylene chloride. |
Complies |
|
Identification |
HPLC |
The principal peak in the chromatogram obtained with the rest solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution. |
complies |
IR |
Consistent with reference standard |
complies |
|
HPLC |
The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution |
Complies |
|
IR |
Consistent with reference standard |
Complies |
|
Residue on ignition |
≤0.2% |
0.02% |
|
Specific optical rotation |
+168°~ +183°(anhydrous substance) |
+176° |
|
PH |
5.5 ~ 7.5 |
6.6 |
|
Sulphate Ash |
≤0.2% |
0.0% |
|
Water |
≤4.0% |
1.8% |
|
Clarity & colour of solution |
Solution should be clear and colorless and its absorbance NMT0.15 at 425nm |
Clear 0.01 |
|
Heavy Metals |
≤20ppm |
<20ppm |
|
Total impurities |
≤3.0% |
0.94% |
|
Any impurity |
≤0.2% |
0.04% |
|
Impurity A |
≤0.6% |
0.27% |
|
Impurity B |
≤0.5% |
0.01% |
|
Impurity C |
≤1.5% |
0.26% |
|
Impurity D |
≤1.0% |
0.28% |
|
Impurity E |
≤0.2% |
0.01% |
|
Impurity F |
≤0.3% |
0.01% |
|
Impurity G |
≤0.3% |
undetected |
|
Impurity H |
≤0.2% |
0.01% |
|
Microbiological purity |
Not more than 1000 aerobic bacteria per 1g |
<10 cfu /g |
|
Not more than 100 fungi per 1g |
10cfu/g |
||
Absence of Escherichia coli per 1g |
undetected ed |
||
Assay |
95.0 ~ 102.0% (anhydrous substance) |
95.8% |
|
Residual solvent |
Benzene ≤2ppm |
undetected |
|
Toluene ≤890ppm |
undetected |
||
dimethylbenzene≤2170ppm |
undetected |
||
styrene≤20ppm |
undetected |
||
Conclusion |
Meets the Requirements |
Группа Продуктов : API-интерфейс > Сердечно-сосудистые