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Items |
Specification |
Result |
|
Appearance |
almost white to yellowish Crystalline powder |
conform |
|
Melting Point |
142.0~146.0℃ |
145℃ |
|
Assay |
N.L.T 98.5% on dried basis |
99.6 % |
|
Identification:
|
color reaction,the color of pale blue to purple develops |
conform |
|
HPLC,the retention time of principal peak should comply with its CRS. |
conform
|
|
|
related substance:
|
Any other single impurity: N.M.T. 0.5% |
0.20%Total |
|
impurities: N.M.T. 1.0% |
0.39% |
|
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