Description

Pramipexole Impurity 7 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Pramipexole. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of Pramipexole-based medications.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Pramipexole API.
• Critical component in method development and validation for HPLC, UPLC, and GC analytical procedures.
• Essential for stability studies and degradation pathway elucidation of Pramipexole formulations.
• Used in regulatory compliance and filing to meet ICH Q3A(R2) and Q3B(R2) guidelines for impurity reporting.
• Serves as a key impurity marker in the quality control batch release process for pharmaceutical manufacturers.
• Valuable for pharmacopoeial testing to verify compliance with USP, EP, or other pharmacopoeia monographs.

Basic Information

Product Name	Pramipexole Impurity 7
CAS No.	106092-09-5
Molecular Formula	C10H17N3S
Molecular Weight	203.33 g/mol
Synonyms	Pramipexole Related Compound 7; (6S)-6-N-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine; (6S)-2-Amino-6-(propylamino)-4,5,6,7-tetrahydro-1,3-benzothiazole; Pramipexole EP Impurity B; Pramipexole USP Impurity; SND 919 Impurity; Pramipexole Dihydrochloride Impurity
EINECS	Contact for details

Quality Control

Every batch of Pramipexole Impurity 7 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements of pharmaceutical impurity standard suppliers. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity, NMR, and mass spectrometry confirmation. We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 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.