Description

Pramipexole Impurity 7, also known as Pramipexole N2-Propionyl Impurity, is a designated reference standard crucial for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Pramipexole. This compound is essential for pharmaceutical manufacturers and research laboratories to ensure product purity, safety, and regulatory compliance by accurately identifying and quantifying this specific process-related impurity. It is primarily used in the development, validation, and routine testing of Pramipexole drug substances and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the identification and quantification of Pramipexole Impurity 7 in API and drug product testing.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Pramipexole.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure they remain within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in synthetic chemistry research to study the formation pathways and mitigation strategies for this impurity during API synthesis.

Basic Information

Product Name	Pramipexole Impurity 7 / Pramipexole N2-Propionyl Impurity
CAS No.	1801892-43-2
Molecular Formula	C13H21N3OS
Molecular Weight	267.39 g/mol
Synonyms	Pramipexole N-Propionyl Impurity; Pramipexole Related Compound 7; N-Propionyl Pramipexole; (S)-N-Propionyl-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine; Pramipexole Propionamide Impurity; Pramipexole Impurity F (Potential); Pramipexole EP Impurity G (Potential)
EINECS	Contact for details

Quality Control

Every batch of Pramipexole Impurity 7 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability data 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) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	97.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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