Description

Argatroban Impurity 23 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the anticoagulant drug Argatroban by enabling precise identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory bodies focused on method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Argatroban Active Pharmaceutical Ingredient (API) and finished drug products.
• Method Development and Validation in analytical laboratories for HPLC, UPLC, and LC-MS techniques.
• Quality Control and Assurance to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies to track the formation of degradation products under various stress conditions.
• Regulatory Submissions and dossier preparation, providing necessary impurity characterization data for FDA, EMA, and other health authority filings.
• Research and Development of synthetic pathways and purification processes for Argatroban.

Basic Information

Product Name	Argatroban Impurity 23
CAS No.	1356847-56-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Argatroban Related Compound 23; Argatroban Impurity C; Argatroban EP Impurity C; Argatroban USP Impurity; (2R,4R)-4-Methyl-1-[(2S)-2-[[(2S,3S)-1-[(2S)-2-[(4-Carbamimidoylphenyl)amino]-1-oxo-3-phenylpropyl]-3-methyl-2-oxopiperidin-3-yl]amino]-1-oxo-3-phenylpropyl]-2-piperidinecarboxylic acid (potential structure-based synonym); Argatroban Degradation Product
EINECS	Contact for details

Quality Control

Our Argatroban Impurity 23 is manufactured under strict quality systems to meet the exacting standards of pharmaceutical impurity analysis. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with in-house specifications aligned with ICH guidelines. We support regulatory needs with full traceability and documentation.

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) and must be kept under dry, inert conditions to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.