Description

Pramipexole Dihydrochloride is a high-purity active pharmaceutical ingredient (API) and key synthetic intermediate. This compound is critical for the production of pharmaceutical formulations targeting neurological disorders. It is primarily utilized by pharmaceutical manufacturers and advanced research institutions in the development and commercial production of dopamine agonist therapies. Consistent quality and reliable supply are paramount for ensuring the efficacy and safety of the final drug product.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of finished dosage forms, such as tablets and capsules, for the treatment of Parkinson's disease and Restless Legs Syndrome (RLS).
• Reference Standard: Serves as a certified reference material (CRM) for quality control laboratories to validate analytical methods, including HPLC and LC-MS, for drug substance and product testing.
• Biochemical Research: Used in preclinical and clinical research studies to investigate dopaminergic pathways, receptor binding, and the pharmacodynamics of dopamine D2-like receptor agonists.
• Process Development: Acts as a critical intermediate in chemical process development and optimization for scalable API synthesis within GMP environments.
• Generic Drug Manufacturing: Essential for companies producing generic versions of pramipexole-containing medications, requiring strict adherence to pharmacopeial standards (USP/EP).

Basic Information

Product Name	Pramipexole Dihydrochloride
CAS No.	1254579-15-1
Molecular Formula	C10H17N3S • 2HCl
Molecular Weight	302.25 g/mol
Synonyms	Pramipexole 2HCl; (S)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole Dihydrochloride; SND 919 Dihydrochloride; Mirapex Impurity Dihydrochloride; (6S)-6-N-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine Dihydrochloride; Pramipexole Dihydrochloride Monohydrate (hydrate form); Pramiracetam Related Compound (not to be confused); Dopamine D2/D3 Receptor Agonist Dihydrochloride
EINECS	Contact for details

Quality Control

Our Pramipexole Dihydrochloride is manufactured under strict quality management systems. Each batch is tested to meet stringent specifications, including identity, purity, and impurity profiles, aligning with current pharmacopeial guidelines (USP/EP) for pharmaceutical actives. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters to ensure regulatory compliance and batch-to-batch consistency.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details

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