|
Item
|
Specification
|
Result
|
||
|
Description
|
White powder
|
White powder
|
||
|
ldentification (By IR)
|
Test infrared spectrum of the sample should be same as the infrared spectrum of the creatinine reference standard obtained in same manner.
|
Conform
|
||
|
ldentification (By HPLC)
|
The retention time of the major peak in the sample solution corresponds to that of the standard solution, as obtained in the assay.
|
Conform
|
||
|
Solubility
|
Slightly soluble in water, insoluble inalcohol, or ether.
|
Conform
|
||
|
Loss on drying
|
10.5%-12.5%
|
|
||
|
Residue on ignition
|
NMT 0.1%
|
0.02%
|
||
|
Chloride and Sulfate
|
NMT 0.1%
|
Conform
|
||
|
Bulk Density
|
As the report
|
640gL
|
||
|
Tapped Bulk Density
|
As the report
|
841gL
|
||
|
Dicyandiamide
|
|
0.005%
|
||
|
Dihydrotriazine
|
NMT 0.0005%
|
Not Detected
|
||
|
Creatinine
|
NMT 0.01%
|
0.003%
|
||
|
Any unspecified impurity
|
NMT 0.10%
|
Not Detected
|
||
|
Total unspecified impurities
|
NMT 1.5%
|
Not Detected
|
||
|
Total impurities
|
NMT 2.0%
|
0.007%
|
||
|
≤ 10cfuv'g
|
<10cfu/g
|
