Description

Pramipexole Dihydrochloride Monohydrate is a high-purity, non-ergoline dopamine agonist used as a critical active pharmaceutical ingredient (API). This compound is essential for its potent and selective activity on dopamine D2 subfamily receptors. It is primarily required by pharmaceutical manufacturers and research institutions for the development and production of treatments for Parkinson's disease and Restless Legs Syndrome (RLS). Our supply is characterized by stringent quality control, ensuring reliability for sensitive formulation processes.

Application

• Pharmaceutical API: Primary use as the active ingredient in solid oral dosage forms (e.g., tablets) for Parkinson's disease therapy.
• Neurological Disorder Treatment: Formulation into medications for managing symptoms of Restless Legs Syndrome (RLS).
• Clinical Research: Serves as a reference standard and key material in preclinical and clinical studies for new neurological therapeutics.
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent generic versions of branded pramipexole medications.
• Drug Development: Utilized in R&D for exploring new indications and delivery mechanisms for dopamine agonist therapies.
• Analytical Testing: Used as a certified reference material (CRM) in quality control laboratories for assay validation and impurity profiling.

Basic Information

Product Name	Pramipexole Dihydrochloride Monohydrate
CAS No.	191217-81-9
Molecular Formula	C10H17N3S • 2HCl • H2O
Molecular Weight	302.26 g/mol (monohydrate salt form)
Synonyms	Pramipexole 2HCl monohydrate; (S)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate; SND 919; SND-919; Mirapexin API; Mirapex API; Pramipexole HCl hydrate
EINECS	Contact for details

Quality Control

Our Pramipexole Dihydrochloride Monohydrate is manufactured and tested under strict quality management systems. We ensure compliance with current Good Manufacturing Practice (GMP) guidelines and relevant pharmacopeial standards (e.g., USP, EP) for pharmaceutical ingredients. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, available upon request to guarantee traceability and suitability for your regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 that minimize exposure to humidity.

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water Content (KF)	5.0% - 7.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.15% Total impurities: ≤ 0.5%
Optical Rotation	-61.0° to -65.0° (c=1 in water)

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