Description

Argatroban Impurity 6 is a specified impurity of the direct thrombin inhibitor Argatroban, a critical anticoagulant used in clinical settings. This high-purity reference standard is essential for pharmaceutical research, development, and quality control to ensure the safety and efficacy of the final drug product. It is primarily used by analytical chemists and quality assurance professionals in pharmaceutical manufacturing and contract research organizations (CROs) for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Argatroban active pharmaceutical ingredient (API) and finished drug products.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to confirm impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to comply with FDA, EMA, and other global health authority requirements.
• Process Chemistry Research: Aids in understanding the synthesis pathway of Argatroban, helping to optimize processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Argatroban Impurity 6
CAS No.	189264-04-8
Molecular Formula	C23H36N6O5S
Molecular Weight	508.64 g/mol
Synonyms	(2R,4R)-4-Methyl-1-[(2S)-2-[[(2S,3R)-1-[(2S)-2-[(aminoiminomethyl)amino]-3-methyl-1-oxobutyl]-3-methyl-2-piperidinyl]carbonyl]amino]-5-(diaminomethylideneamino)-1-oxopentyl]-2-piperidinecarboxylic acid; Argatroban Related Compound; Argatroban EP Impurity; Argatroban USP Impurity; Argatroban Process Impurity; (2R,4R)-1-[(2S)-5-(Carbamimidamido)-2-[[(2S,3R)-1-[(2S)-2-(Carbamimidamido)-3-methylbutanoyl]-3-methylpiperidine-2-carbonyl]amino]pentanoyl]-4-methylpiperidine-2-carboxylic acid
EINECS	Contact for details

Quality Control

Every batch of Argatroban Impurity 6 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR 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 each shipment, supporting compliance with cGMP and ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The container should be kept in a dry, cool, and well-ventilated area. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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