Description

Pramipexole Impurity 6 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Pramipexole. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Pramipexole Impurity 6 in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Pramipexole API and formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation and level of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) during drug stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and market authorization.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and process impurity investigation for Pramipexole.

Basic Information

Item	Detail
Product Name	Pramipexole Impurity 6
CAS No.	1246818-51-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pramipexole Related Compound 6; Pramipexole Impurity F; Pramipexole EP Impurity F; (S)-N6-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine (related impurity); Pramipecole Impurity 6; Pramipexole Impurity VI; 6-Amino-4,5,6,7-tetrahydro-1,3-benzothiazol-2-yl-propylamine (Impurity)
EINECS	Contact for details

Quality Control

Our Pramipexole Impurity 6 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data, batch-specific results, and traceability are provided to support your regulatory compliance and quality assurance protocols.

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 material should be handled in a low-humidity environment and the container kept sealed when not in use to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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