Description

Pramipexole Related Impurity 3 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 and efficacy of the active pharmaceutical ingredient (API) pramipexole by enabling the accurate identification, quantification, and control of its related substances. It is an essential tool for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D, quality control laboratories, and regulatory affairs to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in pramipexole API and finished dosage forms.
• Method Development and Validation: Critical component in developing and validating sensitive analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control and Batch Release: Used in routine QC testing to ensure pramipexole batches comply with ICH guidelines and specifications for related substances.
• Stability Studies: Employed to monitor impurity formation and degradation pathways in pramipexole under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Research and Development: Facilitates process chemistry optimization by helping to understand and control the formation of this specific impurity during API synthesis.

Basic Information

Product Name	Pramipexole Related Impurity 3
CAS No.	2166216-34-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pramipexole Impurity 3; Pramipexole Related Compound 3; Pramipexole Specified Impurity 3; Pramipexole EP Impurity C; (S)-N6-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine Related Substance 3; Pramipexole Process Impurity; Pramipexole Degradant
EINECS	Contact for details

Quality Control

Every batch of Pramipexole Related Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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