Description

Argatroban Impurity 7 is a high-purity chemical reference standard, specifically identified as a known impurity of the anticoagulant drug Argatroban. This compound is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of impurities during drug substance and product manufacturing. It is an essential tool for quality assurance and regulatory compliance in the pharmaceutical industry, particularly for analytical laboratories and manufacturers involved in the production or quality control of Argatroban.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Argatroban.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Used in-house by API manufacturers and finished dosage form producers to monitor and control impurity levels to meet pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Research and Development: Facilitates studies on the synthesis, degradation pathways, and metabolism of Argatroban.

Basic Information

Product Name	Argatroban Impurity 7
CAS No.	188659-43-0
Molecular Formula	C23H36N6O5S
Molecular Weight	508.64 g/mol
Synonyms	(2R,4R)-4-Methyl-1-[(2S)-2-[[(2S,3S)-1-[(2S)-2-[(3-Methyl-1,2,4-thiadiazol-5-yl)amino]-1-oxo-3-phenylpropyl]-2-piperidinyl]formyl]-2-piperidinyl]-2-piperidinecarboxylic Acid; Argatroban Related Compound; Argatroban EP Impurity; Argatroban USP Impurity; Argatroban Degradant; (2R,4R)-1-[(2S)-2-[[(2S,3S)-1-[(2S)-2-[(3-Methyl-1,2,4-thiadiazol-5-yl)amino]-1-oxo-3-phenylpropyl]-2-piperidinyl]carbonyl]-2-piperidinyl]-4-methyl-2-piperidinecarboxylic Acid
EINECS	Contact for details

Quality Control

Our Argatroban Impurity 7 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 ensure high purity. We provide detailed Certificates of Analysis (COA) that include batch-specific data on purity, related substances, and residual solvents, supporting its use as a reference standard for pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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