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TEST |
SPECIFICATION |
RESULTS |
Description |
Off-white or white crystalline |
White crystalline |
Specific Rotation(20/D) |
- 44º± 1.5º (C=1,DMF) |
- 44.5 º (C=1,DMF) |
Loss On Drying |
≤0.5 % |
0.22 % |
Residues On Ignition |
≤0.1 % |
0.04 % |
TLC Analysis |
One spot |
One spot |
Assay (HPLC) |
≥98 % |
98.8 % |
E.E |
≥99 % |
99.9 % |