Description

R-Pramipexole Dihydrochloride Monohydrate is a high-purity, non-ergoline dopamine agonist enantiomer, essential for advanced pharmaceutical research and development. Its primary value lies in its critical role as a key chiral intermediate and reference standard in the synthesis of active pharmaceutical ingredients (APIs) targeting neurological disorders. This compound is specifically needed by pharmaceutical manufacturers, contract research organizations (CROs), and academic laboratories focused on developing and scaling treatments for conditions such as Parkinson's disease and restless legs syndrome.

Application

• Pharmaceutical Intermediate: A critical chiral building block in the synthesis of the active pharmaceutical ingredient (API) Pramipexole.
• Reference Standard: Used for analytical method development, validation, and quality control (QC) testing in pharmaceutical manufacturing.
• Research & Development: Serves as a key material in preclinical and clinical research for central nervous system (CNS) therapeutics.
• Process Chemistry: Employed in route scouting, optimization, and scale-up studies for API production.
• Impurity Profiling: Utilized as a marker to identify and quantify related substances in final drug products.
• Regulatory Submissions: Provides essential data and material for drug master files (DMFs) and regulatory compliance documentation.

Basic Information

Product Name	R-Pramipexole Dihydrochloride Monohydrate
CAS No.	908244-04-2
Molecular Formula	C10H17N3S · 2HCl · H2O
Molecular Weight	302.25 g/mol
Synonyms	(R)-Pramipexole Dihydrochloride Monohydrate; (6R)-4,5,6,7-Tetrahydro-N6-propyl-2,6-benzothiazolediamine Dihydrochloride Monohydrate; (R)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole Dihydrochloride Monohydrate; SND 919CL2Y Dihydrochloride Monohydrate; Pramipexole Impurity F (R-Enantiomer) Dihydrochloride Monohydrate; (R)-Pramipexole 2HCl Monohydrate
EINECS	Contact for details

Quality Control

Our R-Pramipexole Dihydrochloride Monohydrate is manufactured under strict quality management systems, ensuring it meets the stringent requirements for pharmaceutical development. Each batch undergoes comprehensive analytical testing, including chiral purity verification, to guarantee identity, potency, and purity. Certificates of Analysis (COA) with detailed chromatographic data (HPLC, chiral HPLC) are provided and can be tailored to support regulatory filings.

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 product is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0% (anhydrous basis)
Chiral Purity (Chiral HPLC)	≥99.0% (R-Enantiomer)
Water Content (KF)	5.0% - 7.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Individual impurity ≤0.5%; Total impurities ≤1.5%

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