|
Item |
Specification |
Test Result |
|
Identification |
The retention time of the major peak (excluding the solvent peak) in the liquid chromatogram of the sample solution is the same as that of the standard solution obtained in the assay. |
Pass test |
|
Appearance |
White to off-white odorless crystalline powder or granular |
60-80mesh |
|
Assay (calculated with reference to the dried substance) |
98.0%-102.0% |
99.3% |
|
Loose bulk density |
≥0.80g/cm³ |
0.91g/cm³ |
|
Particle size |
Pass test |
|
|
Specific Rotation |
+84.0°～+87.5° |
+86.71° |
|
Moisture |
2.0% Max. |
0.10% |
|
Ignited Residue |
0.7% Max. |
0.02% |
|
Hydrolysis Products (Chlorinated monosaccharides) |
0.1% Max. |
Pass test |
|
0-Related Substances (Other chlorinated disaccharides) |
0.5% Max. |
Pass test |
|
Methanol |
0.1% Max. |
＜0.1% |
|
Lead |
1mg/kg Max. |
＜1mg/kg |
|
Arsenic (As) |
3mg/kg Max. |
＜3mg/kg |
|
Heavy Metals (as Pb) |
10mg/kg Max. |
＜10mg/kg |
|
PH of 10% Aqueous Solution |
5.0~8.0 |
5.0 |
|
Total aerobic count |
250cfu/g Max. |
＜20cfu/g |
|
Coliforms |
Negative |
MPN/g＜3.0 |
|
MPN/g＜3.0 |
||
|
S.aureus |
Negative |
ND/25g |
|
Salmonella |
Negative |
ND/25g |
|
Yeasts & Moulds |
50cfu/g Max. |
＜10cfu/g |
|
Conclusion: Product in conformity with FCCVIII,USP43 and E955 standards |
||
