Description

Pramipexole Impurity 2 is a designated reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Pramipexole. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for the production of Pramipexole-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Pramipexole Impurity 2 in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions to determine drug shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to understand and control impurity formation during the manufacturing process of Pramipexole.

Basic Information

Product Name	Pramipexole Impurity 2
CAS No.	106006-85-3
Molecular Formula	C10H17N3S
Molecular Weight	203.33 g/mol
Synonyms	(S)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole; (6S)-6-(Propylamino)-4,5,6,7-tetrahydro-1,3-benzothiazol-2-amine; Pramipexole Related Compound B; Pramipexole EP Impurity B; Pramipexole USP Impurity 2; Pramipexole Impurity B; SND 919 CL2Y
EINECS	Contact for details

Quality Control

Our Pramipexole Impurity 2 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for use as a reference material. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B, USP, and EP guidelines. Our quality commitment ensures batch-to-batch consistency and traceability for your critical pharmaceutical applications.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
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)	≤ 1.0%

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