Description

Pramipexole Dimer Impurity (Mixture Of Diastereomers) is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) pramipexole by accurately identifying and quantifying its dimeric impurities. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and manufacturing. The product is supplied with comprehensive analytical data to support method validation and regulatory compliance.

Application

• Pharmaceutical Impurity Standard: Primary use as a certified reference material (CRM) for the identification and quantification of dimer-related impurities in pramipexole API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of degradation impurities in pramipexole formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Facilitates studies on the synthesis pathways, degradation mechanisms, and toxicological profiles of pramipexole-related substances.

Basic Information

Product Name	Pramipexole Dimer Impurity (Mixture Of Diastereomers)
CAS No.	1147937-31-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pramipexole Dimer; Pramipexole Dimer Related Compound; Pramipexole Impurity Dimer; (6S)-6-N-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine dimer impurity; Pramipexole Diastereomeric Dimer; SND 919 Dimer Impurity; Pramipexole Dihydrochloride Dimer Impurity; Mirapex Impurity Dimer
EINECS	Contact for details

Quality Control

Our Pramipexole Dimer Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards are designed to meet the stringent requirements of pharmaceutical R&D and regulatory compliance, including ICH 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). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0% (Sum of Diastereomers)
Individual Diastereomer Ratio	Provided on COA
Related Substances (HPLC)	Reported on COA
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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