Description

Argatroban Impurity 35 is a designated impurity standard used in the analytical profiling and quality control of the anticoagulant pharmaceutical Argatroban. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Argatroban Impurity 35 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating high-performance liquid chromatography (HPLC) and other analytical methods to monitor impurities.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure drug substance and drug product meet stringent pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Argatroban formulations.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for Argatroban.

Basic Information

Product Name	Argatroban Impurity 35
CAS No.	194809-67-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Argatroban Related Compound 35; Argatroban EP Impurity G; Argatroban USP Impurity; (2R,4R)-4-Methyl-1-[(2S)-2-[[(2S,3S)-1-[(2S)-2-[(5-amidino-2-hydroxyphenyl)methylamino]-5-guanidinopentanoyl]-3-methyl-2-piperidyl]formamido]-3-methylbutanoyl]-2-piperidinecarboxylic acid; Argatroban Degradant; Argatroban Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Argatroban Impurity 35 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and mass spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 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 (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
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 guidelines

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