Description

Pramipexole Impurity 55 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient pramipexole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Pramipexole API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Essential for preparing documentation for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and control strategies.
• Stability Studies: Used to track the formation of degradation products in stability testing of pramipexole formulations.
• Research & Development: Supports synthetic chemistry research, including route scouting and process optimization for impurity control.

Basic Information

Product Name	Pramipexole Impurity 55
CAS No.	959012-83-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pramipexole Related Compound 55; Pramipexole EP Impurity 55; Pramipexole USP Impurity 55; Pramipexole Degradation Product; (6S)-6-N-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine impurity; Prami Impurity 55; Pramipexole Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Pramipexole Impurity 55 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including HPLC purity, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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