| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
|
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|
Test Items |
Standard |
Test Results |
|
Character |
Off-white to White Crystalline powder |
Off-White Crystalline powder |
|
Solubility |
Soluble in Water and Meth .anol, slightly soluble in Ethanol (96%), Almost insoluble |
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% |
Product Description
Mirapex, an non ergot derivative, was launched in the US for treatment of Parkinson's disease. It can be prepared by two related routes, 5 steps and 3 steps, both involving an optical resolution with L-(+)-tartaric acid to afford the (S)-isomer. Mechanistically, it is a presynaptic dopamine D2 autoreceptor agonist which also activates D3-receptors.
It is well absorbed from the GI and excreted in the urine essentially unchanged with a half-life of 8-12 hr. Mirapex had favorable effects on the symptoms without levodopa for patients with advanced PD and allowed a 27% reduction in use of levodopa in combination therapy. It had an adverse events profile similar to other dopamine agonists and in advanced patients reduced the mean "on-off" hr/day from 6 to 4. It was safe but not efficacious in all patients.
Product Function
1. Pramipexole is used alone or with other medications to treat Parkinson's disease. It can improve your ability to move and decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. It may also decrease the number of episodes of not being able to move ("on-off syndrome").
2. Pramipexole is also used to treat a certain medical condition (restless legs syndrome - RLS) that causes an unusual urge to move the legs. Symptoms usually occur at night along with uncomfortable/unpleasant feelings in the legs. This medication can decrease these symptoms and thereby improve sleep.
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