| Item |
Standard / Specification |
Test Result |
Test Method |
| Purity |
≥99% |
99.6% |
HPLC |
| Assay |
≥98% |
99.5% |
HPLC |
| Physical and Chemical Control: |
|
|
|
| Appearance |
White powder |
Complies |
Visual |
| Mesh Size |
100% pass 100 mesh |
Complies |
Sieve |
| Melting Point |
189-190℃ |
189℃ |
USP<741> |
| Specific Rotation |
[α]D<(-)21° (c=5.0g/L, Ethanol) |
-21.1° |
USP<781> |
| Loss on Drying |
≤1% |
0.12% |
USP<731> |
| Solvent Residue (Ethanol) |
<200 ppm |
84 ppm |
USP<467> |
| Heavy Metals Control: |
|
|
|
| Arsenic (As) |
≤1 ppm |
Complies |
USP<233> |
| Lead (Pb) |
≤1 ppm |
Complies |
USP<233> |
| Mercury (Hg) |
≤1 ppm |
Complies |
USP<233> |
| Cadmium (Cd) |
≤1 ppm |
Complies |
USP<233> |
| Total Heavy Metals |
≤10 ppm |
Complies |
USP<233> |
| Microbiological Control: |
|
|
|
| E. coli |
Not detected |
Complies |
USP<62> |
| Staphylococcus aureus |
Not detected |
Complies |
USP<62> |
| Salmonella |
Not detected |
Complies |
USP<62> |
| Total Coliforms |
<100 CFU/g |
Complies |
AOAC |
| Total Yeast & Mold |
≤100 CFU/g |
Complies |
USP<61> |
| Total Plate Count |
≤1000 CFU/g |
Complies |
USP<61> |