Description

Pramipexole is a potent, non-ergoline dopamine agonist with high selectivity for the D2 subfamily of dopamine receptors. This compound is of critical importance in the pharmaceutical industry for the development of active pharmaceutical ingredients (APIs) targeting neurological disorders. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the production and development of treatments for Parkinson's disease and restless legs syndrome (RLS).

Application

• Active Pharmaceutical Ingredient (API) for the formulation of anti-Parkinsonian medications.
• Key intermediate in the synthesis of finished dosage forms, such as tablets and extended-release formulations.
• Reference standard for quality control and analytical method development in pharmaceutical laboratories.
• Research and development of novel therapeutic agents targeting dopamine D2 and D3 receptors.
• Pre-clinical and clinical studies investigating neurological pathways and drug efficacy.
• Production of generic pharmaceutical products following patent expiration.

Basic Information

Product Name	Pramipexole
CAS No.	104632-26-0
Molecular Formula	C10H17N3S • 2HCl
Molecular Weight	302.26 g/mol (as dihydrochloride monohydrate)
Synonyms	Pramipexole Dihydrochloride; SND 919; SND-919; (S)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole Dihydrochloride; Mirapex; Mirapexin; Pexola; Sifrol; 2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole Dihydrochloride
EINECS	Contact for details

Quality Control

Our Pramipexole is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity pharmaceutical standards, including identity, purity, and impurity profile verification. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting compliance with relevant specifications. We support compliance with cGMP, ICH Q7, and other major pharmacopoeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Optical Rotation	Specific range provided on COA

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.