Description

Argatroban Impurity 43 CAS NO 252985-90-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the anticoagulant drug Argatroban by serving as a key marker in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on compliance and drug substance characterization. This impurity standard supports the stringent requirements of modern pharmacopeial guidelines for impurity identification and control.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Argatroban Impurity 43 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating stability-indicating HPLC or LC-MS methods for Argatroban.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Argatroban API, supporting regulatory filings.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Compliance & Submission: Provides essential data for regulatory documentation (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Facilitates studies on the degradation pathways, pharmacokinetics, and toxicological profile of Argatroban-related substances.

Basic Information

Product Name	Argatroban Impurity 43
CAS No.	252985-90-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Argatroban Related Compound 43; Argatroban Impurity C; (2R,4R)-4-Methyl-1-[(2S)-2-[[(2S,3S)-1-[(2S)-2-[(4-Carbamimidoylphenyl)amino]-3-methylbutanoyl]-3-methyl-2-piperidyl]formamido]-3-methylbutanoyl]-2-piperidinecarboxylic acid; Argatroban Degradant; Argatroban Process Impurity
EINECS	Contact for details

Quality Control

Our Argatroban Impurity 43 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity confirmation via spectroscopic methods (NMR, IR, MS), and impurity profile by HPLC. We support compliance with ICH Q3A/B guidelines and pharmacopeial standards. COAs are available upon request and can be provided with full traceability.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. 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 (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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