Description

Argatroban Impurity CAS NO 1448417-84-2 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Argatroban, a direct thrombin inhibitor anticoagulant. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control of related substances during manufacturing. It is an essential material for analytical laboratories, quality assurance departments, and research scientists working in pharmaceutical development, regulatory compliance, and process chemistry.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of specific impurities in Argatroban Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling and stability-indicating assays.
• Quality Control & Batch Release Testing: Employed as a system suitability standard and for preparing calibration curves to ensure Argatroban batches meet stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Aids in monitoring the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish drug shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this specific impurity during Argatroban manufacturing.

Basic Information

Item	Detail
Product Name	Argatroban Impurity
CAS No.	1448417-84-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Argatroban Related Compound; Argatroban Specified Impurity; (2R,4R)-4-Methyl-1-[(2S)-2-[[(2S,3S)-1-[(2S)-2-[(4-Carbamimidoylphenyl)amino]-5-guanidinopentanoyl]-3-methyl-2-piperidyl]formamido]-5-guanidinopentanoyl]-2-piperidinecarboxylic acid (specific isomer); Argatroban Process Impurity; Argatroban Degradant; Anticoagulant Impurity Standard; Thrombin Inhibitor Impurity
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results and traceability. Our quality protocols are designed to support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.