Description

Argatroban Impurity 33 is a high-purity chemical reference standard used in the analytical profiling and quality control of the anticoagulant drug Argatroban. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential tool for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Argatroban active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, calibrate, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific impurity over time.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive identification and characterization of a specified impurity.
• Pharmacopoeial Testing: May be used for testing in compliance with pharmacopoeial monographs (e.g., USP, EP, JP) that specify limits for related substances.
• Research & Development: Serves as a key intermediate or degradation product for studying the metabolism, synthesis pathways, and chemical behavior of Argatroban.

Basic Information

Product Name	Argatroban Impurity 33
CAS No.	450368-56-6
Molecular Formula	C23H36N6O5S
Molecular Weight	508.64 g/mol
Synonyms	Argatroban Related Compound 33; (2R,4R)-4-Methyl-1-[(2S)-2-[[(2S,3S)-1-[(2S)-2-[(5-Amidino-2-pyridinyl)methyl]-1-oxo-3-sulfopropyl-2-piperazinyl]carbonyl]-2-piperidyl]carbonyl]-2-piperidinecarboxylic Acid; Argatroban EP Impurity G; Argatroban USP Impurity; Argatroban Degradation Product; Argatroban Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Argatroban Impurity 33 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

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

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 ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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