Description

Argatroban Impurity 75 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of the anticoagulant drug Argatroban, ensuring product safety and regulatory compliance. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in method development and validation.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for identifying and quantifying related substances in Argatroban active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Used as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Assurance & Control (QA/QC): Essential for routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the Argatroban synthesis pathway to minimize impurity formation.

Basic Information

Product Name	Argatroban Impurity 75
CAS No.	85796-64-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Argatroban Related Compound 75; Argatroban Impurity C; (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; Argatroban EP Impurity C; Argatroban USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Argatroban Impurity 75 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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