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TEST ITEMS |
STANDARD PRESCRIBE |
RESULTS |
Appearance |
White or yellowish-white crystalline powder |
White crystalline powder |
Solubility |
Practically insoluble in water ,freely soluble in methylene chloride,soluble in alcohol |
Confroms |
Identification |
A:IR B:HPLC |
Conforms |
Appearance of solution |
Solution is clear ,≤BY7 |
Clear, |
Specific optical rotation |
-17 to -20 ° |
-18.5° |
Related substances |
|
|
Impurity with a relative retention of 1.3 to 1.5 (%) |
≤2.5 % |
1.6% |
Any other impurity(%) |
≤ 1 |
0.5% |
Total (%) |
≤5 |
3.3% |
Ethanol (%) |
≤5.0 |
3.5% |
Formamide (%) |
≤3.0% |
2.5% |
Heavy metaals (%) |
≤0.002 |
<0.002% |
Water (%) |
≤1.0 |
0.2% |
Sulphated ash (%) |
≤0.1. |
0.05% |
Content |
|
|
H2B1(%) |
95.0-102.0 |
96.0% |
H2B1a/H2B1(%) |
≥90.0 |
98.0% |
Conclusion |
This product complies with EP6.0 standard |
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
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