Description

Dabigatran Impurity 13 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the anticoagulant drug Dabigatran etexilate by enabling precise identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory compliance teams. The availability of this well-characterized impurity supports method development, validation, and stability studies in accordance with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Dabigatran etexilate (Pradaxa®) active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: A critical component for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure drug substance and drug product batches meet stringent pharmacopeial (e.g., USP, EP) and internal specification limits for related substances.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity characterization and control strategies to agencies like the FDA and EMA.
• Research & Process Chemistry: Aids in understanding the synthetic pathway of Dabigatran and helps in optimizing manufacturing processes to minimize the formation of this specific impurity.

Basic Information

Item	Details
Product Name	Dabigatran Impurity 13
CAS No.	1427571-33-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Related Compound 13; Dabigatran Etexilate Impurity 13; 1-({[(Hexyloxy)carbonyl]amino}methyl)-2-{[(4-{[(hexyloxy)carbonyl]amino}phenyl)amino]methyl}-1H-benzimidazole-5-carboxylic acid (putative); Dabigatran Process Impurity; Pradaxa Impurity 13; BIBR 953 Impurity; BIBR 1048 MS Impurity
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Impurity 13 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR 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. Our quality commitment aligns with the needs of cGMP-compliant environments and supports regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0%; Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.