BP2015 Standard
Items |
Specification |
Appearance |
white or almost white crystals or powder |
Solubility |
freely soluble in water, practically insoluble in ethanol(96%) |
Identification |
Specific rotation +23o - +25o |
|
Melting point 165-170oC |
|
Infrared absorption conform |
Appearance of solution |
clear & colorless |
Conductivity |
≤20μS/cm |
Reduce sugar |
≤0.1% |
Related substances |
A(Sorbitol) ≤2.0% |
|
B+C(Maltitol+ Isomalt) ≤2.0% |
|
Unspecified ≤0.1% |
|
Total ≤2.0% |
Heavy metal |
≤5ppm |
Nickel |
≤1ppm |
Loss on drying |
≤0.5% |
Microbiological |
Total aerobic count ≤103cfu/g |
|
Yeast&mold ≤102cfu/g |
|
E.Coli negative |
|
Salmonella negative |
Assay |
97.0-102.0% |
Bacterial endotoxin |
≤2.5EU/g |