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Pramipexole Manufacturing United Kingdom and USA
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Pramipexole

  • Product Name : Pramipexole
  • Grade : IP / BP / USP
  • Therapeutic Category : Antidyskinetic
  • CAS No : 104632-26-0
  • Other Name : PRAMIPEXOLE DIHYDROCHLORIDE
  • COA : Available
  • MSDS : Available

Description

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.

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