Description

Pramipexole Sulfoxide is a key pharmaceutical intermediate and impurity standard, essential for ensuring the quality and safety of active pharmaceutical ingredients (APIs). This compound is of critical importance in the development, validation, and quality control processes for dopamine agonist medications. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on neurology and central nervous system (CNS) therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the assay and related substance testing of Pramipexole dihydrochloride monohydrate API.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Process Chemistry Research: Employed in studying metabolic pathways, degradation profiles, and synthesis optimization during drug development.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data.
• Academic & Clinical Research: Utilized in pharmacological studies to understand the metabolism and stability of pramipexole.

Basic Information

Product Name	Pramipexole Sulfoxide
CAS No.	1825352-05-3
Molecular Formula	C10H17N3OS
Molecular Weight	227.33 g/mol
Synonyms	(S)-Pramipexole Sulfoxide; (6S)-4,5,6,7-Tetrahydro-N6-propyl-2,6-benzothiazolediamine S-Oxide; Pramipexole Impurity F (Sulfoxide); Pramipexole Related Compound F; SND 919 CL2x; U-98,528 Sulfoxide; (6S)-6-N-Propylamino-4,5,6,7-tetrahydrobenzothiazole-2,6-diamine S-Oxide
EINECS	Contact for details

Quality Control

Our Pramipexole Sulfoxide is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS). We provide full traceability and Certificates of Analysis (COA) that detail all test results, ensuring compliance with ICH guidelines and current Good Manufacturing Practice (cGMP) principles for pharmaceutical impurities.

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 under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.