Description

Pramipexole Impurity 32 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification and quantification of process-related impurities in Pramipexole drug substances and finished products. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in method development, validation, and regulatory compliance testing for this important dopamine agonist medication.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Pramipexole.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurities in active pharmaceutical ingredients (APIs).
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers and finished dosage form producers to ensure batch-to-batch consistency and purity.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing data on impurity profiles as required by ICH guidelines Q3A(R2) and Q3B(R2).
• Stability Studies: Employed to identify and track degradation products in forced degradation and long-term stability testing of Pramipexole formulations.
• Research & Development: Used in pharmaceutical R&D to study the synthesis pathway, degradation pathways, and metabolism of Pramipexole.

Basic Information

Product Name	Pramipexole Impurity 32
CAS No.	1973461-14-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pramipexole Related Compound 32; Pramipexole EP Impurity 32; Pramipexole USP Impurity 32; Pramipexole Process Impurity; (S)-N6-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine Impurity; Prami Impurity 32; Pramipexole Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Pramipexole Impurity 32 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available for review upon request to support your regulatory needs.

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 container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
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.