|
Item |
Standard |
Result |
|
Appearance |
White powder |
Complies |
|
Identification |
IR |
Complies |
|
HPLC |
Complies |
|
|
Heavy metal |
≤10ppm |
5ppm |
|
Pb |
≤3ppm |
1.5ppm |
|
Hg |
≤0.1ppm |
0.05ppm |
|
Cd |
≤1ppm |
0.2ppm |
|
Loss on drying |
≤0.5% |
0.12 |
|
Residue on lgnition |
≤0.1% |
0.03 |
|
Single impurity |
≤0.5% |
0.12 |
|
Total impurity |
≤1.0% |
0.29 |
|
Total bacteria |
≤1000cfu/g |
<1000 |
|
Yeast and Mould |
≤100 cfu/g |
<000 |
|
E.coli/25g |
Absent |
Absent |
|
Salmonella/25g |
Absent |
Absent |
|
Assay |
≥99.0% |
99.4% |
|
Conclusion |
Conforms with USP/EP standards |
|