Description

Pramipexole Impurity 23 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 Pramipexole Impurity 23 in drug substances and products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor impurities in Pramipexole API.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Pramipexole API batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Acts as a critical marker in forced degradation and long-term stability studies to understand the degradation pathways of Pramipexole.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Research & Development: Utilized in R&D to study the synthesis, isolation, and toxicological profile of this specific impurity.

Basic Information

Product Name	Pramipexole Impurity 23
CAS No.	17557-67-4
Molecular Formula	C10H17N3S
Molecular Weight	203.33 g/mol
Synonyms	Pramipexole Related Compound 23; (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 C; Pramipexole Impurity C; SND 919 Impurity
EINECS	Contact for details

Quality Control

Our Pramipexole Impurity 23 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 1.0%
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.