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 |