- Min.Order :0 Metric Ton
- Purity: Minimum 590IU/mg
Keywords
Quick Details
- Appearance:
- Application:CAS: 1405-41-0
- PackAge:
- ProductionCapacity:|Metric Ton|Day
- Storage:
- Transportation:
Superiority:
GMP certificate
Details:
|
ITEMS |
SPECIFICATIONS |
RESULTS |
|
Character |
White or almost white, hygroscopic powder |
White ,hygroscopic powder |
|
Identification |
Corresponding to reference spectrum |
|
|
Appearance of solution |
Clear and not more intensely colored than intensely 6 of the range of reference solutions of the most appropriate color |
Complies |
|
pH |
3.5--5.5 |
5.0 |
|
Specific optical rotation (anhydrous substance) |
+107º to +121º |
+120º |
|
Methanol |
Max 1.0% |
Not tested |
|
Composition |
C1:20.0%--40.0% |
26.7 |
|
C1a:10.0%--30.0% |
27.6% |
|
|
C2+C2a+C2b:40%--60.0% |
45.7% |
|
|
Related substance |
Any impurity Max 3.0% |
1.7% |
|
Total Max 10.0% |
3.1% |
|
|
Water |
Max 15.0% |
8.0% |
|
Sulphated ash |
Max 1.0% |
0.2% |
|
Sulphate (anhydrous substance) |
32.0%--35.0% |
33.8% |
|
Bacterial endotoxins |
Less than 0.71IU/mg |
<0.50IU/mg |
|
Assay (anhydrous substance) |
Minimum 590IU/mg |
661IU/mg |
|
Conclusion |
This batch product complies with European Pharmacopoeia 6.0 specification. |
|
|
Remark |
Methanol is not used during the production. |
|
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