Description

Argatroban Impurity 99 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, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: 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 and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within QC laboratories to monitor impurity levels and ensure adherence to strict pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to track impurity formation and assess drug shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive understanding and control of the drug substance impurity profile.
• Research and Development: Used in synthetic chemistry R&D to study degradation pathways and optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Argatroban Impurity 99
CAS No.	450368-52-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Argatroban Related Compound; Argatroban Impurity; Argatroban Degradant; Argatroban Process Impurity; (2R,4R)-4-Methyl-1-[(2S)-2-[[(2S,3S)-1-[(3S)-2-oxopyrrolidin-3-yl]-2-oxo-3-[(pyridin-2-ylsulfanyl)methyl]azetidin-3-yl]amino]-3,3-dimethylbutanoyl]piperidine-2-carboxylic acid (IUPAC); Argatroban EP Impurity; Argatroban USP Impurity
EINECS	Contact for details

Quality Control

Our Argatroban Impurity 99 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, NMR, and Mass Spectrometry. We adhere to relevant ICH guidelines and can support compliance with pharmacopeial standards (USP, EP) for pharmaceutical impurity reference materials.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.