Description

Argatroban Impurity 12 Dihcl is a high-purity chemical reference standard, specifically the dihydrochloride salt of a key process-related impurity of the anticoagulant drug Argatroban. This compound is critically important for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of impurities to ensure drug safety and efficacy. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical and biotechnology industries involved in method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantitative and qualitative analysis of Argatroban and its related substances.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS/MS methods to separate and detect impurities in Argatroban active pharmaceutical ingredient (API) and finished drug products.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles, ensuring compliance with ICH Q3A/B guidelines and specified limits in pharmacopeial monographs.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability-indicating assays.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate understanding and control of the drug substance impurity profile.
• Process Chemistry Research: Aids in understanding the synthesis pathway of Argatroban, helping to optimize manufacturing processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Argatroban Impurity 12 Dihcl
CAS No.	2010950-58-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Argatroban Related Compound 12 Dihydrochloride; Argatroban Impurity 12 Dihydrochloride; (2R,4R)-4-Methyl-1-[(2S)-2-[[(2S,3S)-1-[(2S)-2-[(3-Methyl-1,2,3,4-tetrahydroquinolin-8-yl)sulfonyl]carbamoyl]pyrrolidin-3-yl]carbamoyl]pyrrolidine-1-carbonyl]-2-piperidinecarboxylic Acid Dihydrochloride; Argatroban EP Impurity H Dihydrochloride; Argatroban USP Impurity Dihydrochloride
EINECS	Contact for details

Quality Control

Our Argatroban Impurity 12 Dihcl is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. Certificates of Analysis (COA) are provided, detailing comprehensive results against stringent in-house specifications. We support compliance with current Good Manufacturing Practices (cGMP) and relevant ICH guidelines for impurities in new drug substances.

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 under dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified 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.