Citicoline is used for Alzheimer's disease and other types of dementia, head trauma, cerebrovascular disease such as stroke, age-related memory loss, Parkinson's disease, and glaucoma.
Specification:
|
Test Item |
Specification |
Result |
|
Appearance |
White crystalline powder |
White crystalline powder |
|
solubility |
Easily soluble in water, unsoluble in ethanol |
Conforms |
|
Identification |
1.2.3 Conforms |
Conforms |
|
PH |
6.0~7.5 |
6.7 |
|
Solution clarity and color |
Solution should be clear and colorless |
Conforms |
|
Related substances |
5’-CMP≤0.3% |
0.02% |
|
Related substances |
Individual impurity ≤0.2% |
0.04% |
|
Related substances |
Total impurity ≤1.0% |
0.2% |
|
chloride |
≤0.05% |
Conforms |
|
Ammonium |
≤0.05% |
Conforms |
|
Fe |
≤0.01% |
Conforms |
|
phosphate |
≤0.1% |
Conforms |
|
Loss on drying |
≤6% |
1.3% |
|
Heavy metals |
≤0.002% |
Conforms |
|
Arsenide |
≤0.0001% |
Conforms |
|
Bacterial Endotoxins |
<0.6EU/mg |
Conforms |
|
Methol |
≤0.3% |
0.2% |
|
Ethanol |
≤0.5% |
0.09% |
|
Assay(on dried basis) |
Not less than 98.0% |
99.1% |
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |