Description

Pramipexole Dimer Impurity Ii is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound is essential for the accurate identification and quantification of a specific dimeric impurity in Pramipexole drug substances and finished products, ensuring compliance with stringent regulatory purity specifications. It is primarily used by research scientists and quality assurance professionals in pharmaceutical R&D, analytical laboratories, and API production facilities focused on neurology and movement disorder treatments.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for calibrating analytical instruments like HPLC and LC-MS in impurity profiling.
• Method Development and Validation: Used to develop, optimize, and validate chromatographic methods for the specific separation and detection of Pramipexole-related impurities.
• Quality Control (QC) Testing: Employed in routine batch release testing of Pramipexole Active Pharmaceutical Ingredients (APIs) and finished dosage forms to monitor impurity levels.
• Regulatory Compliance and Filing: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Pramipexole formulations.
• Research and Development: Aids in synthetic route optimization and process chemistry by identifying and quantifying impurity formation during API synthesis.

Basic Information

Product Name	Pramipexole Dimer Impurity Ii
CAS No.	2206826-82-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pramipexole Dimer; Pramipexole Impurity Dimer; Pramipexole Related Compound Dimer II; (6-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazol-2-amine) Dimer Impurity; Pramipexole Dimeric Impurity; SND 919 Dimer Impurity; BI-II 751 BS Dimer Impurity
EINECS	Contact for details

Quality Control

Our Pramipexole Dimer Impurity Ii is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment supports compliance with ICH Q3A/B guidelines and cGMP standards for pharmaceutical impurities.

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); ensure the container is kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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