Description

Pramipexole Impurity 4 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 pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Pramipexole API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation and levels of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate control over the impurity profile of the drug substance.
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during API process development.

Basic Information

Product Name	Pramipexole Impurity 4
CAS No.	104632-25-9
Molecular Formula	C10H17N3S
Molecular Weight	203.33 g/mol
Synonyms	(S)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole; 6-[(Propylamino)methyl]-4,5,6,7-tetrahydro-1,3-benzothiazol-2-amine; Pramipexole Related Compound B; Pramipexole Impurity B; Pramipexole EP Impurity B; Pramipexole USP Impurity B; SND 919 Impurity; U-98,528 Impurity
EINECS	Contact for details

Quality Control

Every batch of Pramipexole Impurity 4 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using techniques such as HPLC, GC, NMR, and MS to ensure identity, purity, and strength. A comprehensive Certificate of Analysis (COA) is supplied with each lot, detailing the results against stringent in-house specifications aligned with ICH guidelines. We support compliance with GMP, ISO, and relevant pharmacopeial standards (USP, EP) for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a cool, dry, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	97.0% - 103.0%

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