Description

Dabigatran Impurity 23 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Dabigatran Etexilate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The product is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Dabigatran Etexilate API and its finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity identification and quantification.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., with FDA, EMA) to demonstrate product safety and compliance with ICH guidelines.
• Research & Development: Serves as a key reagent in R&D for studying the degradation pathways and metabolism of Dabigatran.
• Pharmacopoeial Testing: Used as a system suitability standard in testing procedures aligned with pharmacopoeial monographs (e.g., USP, EP).

Basic Information

Product Name	Dabigatran Impurity 23
CAS No.	1637238-96-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Related Compound 23; Dabigatran Etexilate Impurity 23; 3-[[2-[[[4-[[(Hexyloxy)carbonyl]amino]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoic acid; BIBR 953 Impurity; BIBR 1048 MS Impurity
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Impurity 23 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support compliance with ICH Q3A/B guidelines and relevant pharmacopoeial standards.

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 must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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