rasagiline CAS:136236-51-6
rasagiline mesylate cas 161735-79-1
Certificate of Analysis ( rasagiline mesylate)
Chemical name: (R)- N- 2- Propinyl- 1- indanamin .mesylate
Formula/structure : C12H13N.CH4O3S molecular weight : 267.338 cas No: 161735-79-1
Batch Number: 090905 Analysis Date: 06th Sep., 2009
Batch Quantity: 8.1kgS Certificate Date: 06th Sep., 2009
Manufacture Date: 05th Sep., 2009 Expire Date: 04th Sep., 2011
According to in-house
|
TEST ITEMS |
SPECIFICATION |
RESULTS |
|
Appearance |
white to off-White crystalline powder |
White crystalline powder |
|
Identification |
Meet the Requirments IR spectrum |
IR spectrum |
|
Related substances |
Single Impurity 0.5% Max |
0.22% |
|
Total Impurity 1.0% Max |
0.58% |
|
Loss on Drying |
0.5% Max |
0.15% |
|
Melting point |
152-157 degree |
155 degree |
|
Specific rotation |
18-+22 degree |
+20.60 degree |
|
Residue on ignition |
0.10% Max |
0.02% |
|
Heavy Metals |
20PPM Max |
8ppm |
|
Residual Solvents |
5ppm Max |
1.8ppm |
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Solubility |
Rule of ES，freely soluble in water,methanol and ethanol sparingly soluble in isopropanol |
Conforms/ Rule of ES |
|
Assay (anhydrous basis): |
98% Min |
98.78% |
Conclusion: Conforms with EP5 or Enterprise’s Standard.Shelf Life: 2 years when properly stored
Inspector: Zhenggan Approved: Han Xiaofeng
2009-09-06
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