Pramipexole is a dopamine agonist of the non-ergoline class indicated for treating Parkinson's disease (PD) and restless legs syndrome.
· Product name: Pramipexole
· Purity:99%
· CAS: 104632-26-0
· Molecular formula: C10H17N3S
· Molecular weight: 247.788
· Appearance: white powder
Specification:
|
Test Items |
Standard |
Test Results |
|
Character |
Off-white to White Crystalline powder |
Off-White Crystalline powder |
|
Solubility |
Soluble in Water and Methanol, slightly soluble in Ethanol (96%), Almost insoluble in Dichloromethane |
Complies |
|
Identification |
(1)Specific Rotation -67~-69.5°(on anhydrate basis) (2)IR: Meets the requirement. (3) Optical purity Test (4)Chloride Reaction |
-68.8
Complies Complies Complies |
|
Clarity |
Clear, not deeper than Y6. |
Complies |
|
PH |
2.8~3.4 |
3.15 |
|
Related Substances |
Impurity A≤0.15% Impurity B≤0.15% Impurity C≤0.15% Unknown single impurity≤0.1% Total Impurity≤0.5% |
Not detected 0.04% Not detected 0.05% 0.16% |
|
Impurity D |
Impurity D≤0. 5% |
0.1% |
|
Water |
4.5%~6.5% |
4.9% |
|
Heavy metals |
≤10ppm |
Complies |
|
Sulfate Ash |
≤0.1% |
0.05% |
|
Assay (on anhydrate basis) |
99.0%~101.0% |
99.8% |
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. |