Description

Argatroban Impurity 13 is a high-purity chemical reference standard, specifically identified as an impurity of the anticoagulant drug Argatroban. This compound is critical for pharmaceutical research and development, enabling precise analytical method development and validation to ensure drug safety and efficacy. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control, stability studies, and compliance testing of Argatroban active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of related substances in Argatroban API and drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in pharmaceutical manufacturing to meet ICH guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Submission: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the drug's impurity pathways.

Basic Information

Product Name	Argatroban Impurity 13
CAS No.	94975-84-5
Molecular Formula	C23H36N6O5S
Molecular Weight	508.64 g/mol
Synonyms	(2R,4R)-4-Methyl-1-[(2S)-2-[[(2S,3S)-1-[(2S)-2-[(4-Carbamimidoylphenyl)amino]-3-methylbutanoyl]-3-methyl-2-piperidyl]formamido]-5-guanidino-pentanoyl]-2-piperidinecarboxylic acid; Argatroban Related Compound; Argatroban Impurity; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Argatroban Impurity 13 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities. Our quality commitment aligns with cGMP principles for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under inert atmosphere.

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%
Residue on Ignition	≤ 0.5%

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