Description

Argatroban Impurity 26 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 anticoagulant drug Argatroban. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Argatroban active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing within pharmaceutical manufacturing to ensure batch-to-batch consistency and purity specifications are met.
• Regulatory Submissions: Essential for preparing documentation for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and control strategies.
• Stability Studies: Used to monitor the formation of degradation products in Argatroban formulations under various stress conditions.
• Research & Development: Supports pharmacokinetic, metabolic, and toxicological studies related to Argatroban by providing a characterized impurity standard.

Basic Information

Product Name	Argatroban Impurity 26
CAS No.	189264-02-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Argatroban Related Compound 26; Argatroban EP Impurity 26; Argatroban USP Impurity 26; (2R,4R)-4-Methyl-1-[(2S)-2-[[(2S,3S)-1-[(2S)-2-[(3-Methyl-1,2,3,4-tetrahydroquinolin-8-yl)sulfonyl]carbamoyl]pyrrolidin-3-yl]carbamoyl]pyrrolidine-1-carbonyl]-2-piperidinecarboxylic acid; Argatroban Degradant; Argatroban Process Impurity
EINECS	Contact for details

Quality Control

Our Argatroban Impurity 26 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), 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 product label or COA. The material should be kept in a dry environment and handled with appropriate laboratory safety practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
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.