Description

Dabigatran Impurity 10 (Dabrc-10) is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the anticoagulant drug Dabigatran etexilate by serving as a key marker for analytical method development and validation. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, particularly those involved in the synthesis, purification, and regulatory compliance of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Dabigatran etexilate API and finished dosage forms.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles during drug manufacturing.
• Quality Control & Assurance: Used in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA and EMA.
• Stability Studies: Employed as a marker to track degradation pathways and establish the shelf-life of Dabigatran-containing drug products.
• Process Chemistry Research: Aids in understanding and optimizing synthetic routes to minimize the formation of this specific impurity.

Basic Information

Product Name	Dabigatran Impurity 10 (Dabrc-10)
CAS No.	1304574-20-6
Molecular Formula	C34H41N7O5
Molecular Weight	627.74 g/mol
Synonyms	Dabigatran Related Compound 10; Dabrc-10; Dabigatran Etexilate Impurity 10; (3-{[(2-{[(4-{N'-[(Hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino}propyl)ethylcarbamate; BIBR 953 Impurity 10; Pradaxa Impurity 10
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Impurity 10 (Dabrc-10) is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our products are characterized using advanced techniques including HPLC, LC-MS, and NMR to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters.

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. This product is hygroscopic (moisture-sensitive). Store in a cool, dry place. Keep the container tightly sealed in a desiccated environment to prevent moisture absorption and degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single 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.