|
Item |
Specification |
Test result |
|
|
Organoleptic |
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|
description |
Fine Powder |
Conforms |
|
|
Color |
White powder |
Conforms |
|
|
Identification |
By IR |
Test infrared spectrum of the sample should concordant with the infrared spectrum of the Creatine reference standard obtained in same manner |
Conform |
|
By HPLC |
The retention time of the major peak in the Sampk solution corresponds to that of the Standard solution, as obtained in the Assay. |
Conform |
|
|
Solubility |
soluble in water; insoluble in alcohol, in ether. |
Conform |
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|
Physical&Chemical Characteristics |
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|
Loss on drying |
10.5 - 12.5 % |
11.32 % |
|
|
Residue on ignition |
≤ 0. 1% |
0.02% |
|
|
Chloride and Sulfate |
≤ 0. 1% |
Conform |
|
|
Related impurities |
Dicyandiamide |
≤0.10% |
0.007 % |
|
Dihydrotriazine |
≤0.0005% |
Not Detected |
|
|
Creatinine |
≤0.10% |
0.006% |
|
|
Any unspecified impunity Total unspecified impurities |
≤0.10% ≤1.5% |
Not Detected Not Detected |
|
|
Total impurities |
≤2.0% |
0.013% |
|
|
Microbiological Tests |
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|
total plate count |
≤10cfu/g |
<10cfu/g |
|
|
Yeast & Mold |
Absent |
Conforms |
|
|
Assay |
98.0%~102.0% of C4H₉NO2.H2O calculated on the dried basis |
99.9% |
|
|
Conclusion |
Conforms to Current USP |
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