Description

Pramipexole Ep Impurity E is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Pramipexole. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor Impurity E during the analysis of Pramipexole API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure specificity, accuracy, and precision in impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to verify that Pramipexole products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Essential for preparing compliant documentation for regulatory agencies (FDA, EMA, etc.), providing definitive characterization and control of impurities.
• Research & Development: Supports synthetic route optimization and process chemistry by helping to understand and control the formation of this impurity during API synthesis.

Basic Information

Product Name	Pramipexole Ep Impurity E
CAS No.	106006-84-2
Molecular Formula	C10H17N3S
Molecular Weight	203.33 g/mol
Synonyms	Pramipexole Impurity E; (6S)-6-N-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine; (6S)-6-N-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diyldiamine; Pramipexole Related Compound E; SND 919 CL2Y; (6S)-2,6-Diamino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole
EINECS	Contact for details

Quality Control

Every batch of Pramipexole Ep Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA), detailing results from advanced analytical techniques (HPLC, GC, MS, NMR), is provided with each shipment to guarantee traceability and reliable performance as a reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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