Description

Pramipexole Impurity 14 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) pramipexole dihydrochloride. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Pramipexole API.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) for pharmaceutical quality control.
• Essential for conducting stability studies and forced degradation studies to understand drug product behavior.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity thresholds and specifications.
• Serves as a key material in research and development for studying the metabolism and degradation pathways of pramipexole.
• Supports pharmacopoeial testing to ensure compliance with monographs from USP, EP, or other international standards.

Basic Information

Product Name	Pramipexole Impurity 14
CAS No.	4570-41-6
Molecular Formula	C10H17N3S
Molecular Weight	203.33 g/mol
Synonyms	Pramipexole Related Compound; 2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole; (6R)-6-(Propylamino)-4,5,6,7-tetrahydro-1,3-benzothiazol-2-amine; Pramipexole Impurity B; Pramipexole EP Impurity B; Pramipexole USP Related Compound; SND 919 Impurity
EINECS	Contact for details

Quality Control

Every batch of Pramipexole Impurity 14 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against established specifications. We support compliance with cGMP, ICH Q3A/B guidelines, and relevant pharmacopoeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to 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%
Assay	97.0% - 103.0% (on anhydrous basis)

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