Items
Specifications
Results
Appearance
White crystalline powder
Identification
A.IR spectrum should comply with the CRS
Conform
B.HPLC-RT should comply with the CRS
pH
6.5-8.0
7.2
Water
Not more than 0.5%
0.04%
Residue on ignition
Not more than 0.1%
0.02%
Heavy metals
Not more than 0.002%
Less than 0.002%
Early eluting impurities
Impurity A: not more than 0.1%
0.004%
Impurity B: not more than 0.06%
N.D
Impurity E: not more than 0.10%
Impurity CDMA: not more than 0.10%
Max individual impurity: not more than 0.10%
0.01%
Late eluting impurities
Impurity D: not more than 0.10%
Impurity CAI: not more than 0.10%
Max individual unknown impurity: not more than 0.10%
Total impurity(Early and Late )
0.09%
Residual solvent
Methanol: Not more than 3000ppm
147ppm
Isopropanol: Not more than 5000ppm
127ppm
Methylene chloride: not more 600ppm
Toluene: Not more than 890ppm
Assay(Calculated on the anhydrous basis)
98.0-102.0%
100.1%
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