Description

Argatroban Impurity 54 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 Argatroban, a direct thrombin inhibitor anticoagulant. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and efficacy. The availability of this well-characterized impurity is essential for method validation and meeting stringent regulatory compliance standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Argatroban active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control the levels of this specific impurity, ensuring it remains within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: A key component in forced degradation and long-term stability studies to identify and track impurity formation in Argatroban formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to support the development of robust manufacturing processes for Argatroban.

Basic Information

Item	Details
Product Name	Argatroban Impurity 54
CAS No.	450368-54-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Argatroban Related Compound 54; Argatroban Impurity K; Argatroban EP Impurity K; Argatroban USP Impurity; (2R,4R)-4-Methyl-1-[(2S)-2-[[(2S,3S)-1-[(2S)-2-[(5-amidino-2-pyridinyl)amino]-1-oxobutyl]-3-methyl-2-piperidinyl]carbonyl]amino]-5-(diaminomethylideneamino)-1-oxopentyl]-2-piperidinecarboxylic acid (if applicable); Argatroban Degradation Product; Argatroban Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Argatroban Impurity 54 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques, including HPLC, LC-MS, and NMR, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

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 nature, the container should be kept in a desiccated environment to prevent moisture absorption, which could affect stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

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