Customization: | Available |
---|---|
Powder: | Yes |
Customized: | Customized |
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Item
|
Standred
|
Results
|
Appearance
|
White or almost white crystalline powder
|
Almost white crystalline powder
|
Melting point
|
221-226°C
|
223.0-225.5°C
|
Identification
|
(1)The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation,as obtained in the assay.
|
Complies
|
|
(2)UV absorption Max. at 266nm.
|
Complies
|
(3)IR spectra is consistent with CRS.
|
Complies
|
|
PH
|
3.5-4.5
|
3.8
|
Chloride
|
0.02% max
|
<0.02%
|
Fluorides
|
5.0%min
|
5.2%
|
Related substances
|
Individual impurity not more than 0.5%
|
0.35%
|
Total impurities not more than 2.0%
|
0.76%
|
|
Loss on drying
|
0.3% max
|
0.08%
|
Residue on ignition
|
0.2%max
|
0.05%
|
Heavy metals
|
Less than or egual to 20 millionths
|
Less than20 millionths
|
Assay
|
98.0%min
|
99.7%
|
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