Description

Dabigatran Impurity 73 is a high-purity chemical 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. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in the production of anticoagulant medications.

Application

• Pharmaceutical Impurity Profiling and Identification in Dabigatran Etexilate API and finished dosage forms.
• Analytical Method Development and Validation (HPLC, LC-MS) for quality control laboratories.
• Stability Studies and forced degradation studies to monitor impurity formation.
• Reference Standard for quantitative and qualitative analysis in regulatory submissions (e.g., FDA, EMA).
• Research and Development of Dabigatran Etexilate synthesis pathways and purification processes.
• Pharmacopoeial Testing to comply with USP, EP, or other international monograph requirements.

Basic Information

Product Name	Dabigatran Impurity 73
CAS No.	858967-80-3
Molecular Formula	C34H41N7O5
Molecular Weight	627.74 g/mol
Synonyms	Dabigatran Related Compound 73; Dabigatran Etexilate Impurity 73; Ethyl 3-[[2-[[4-[[(Hexyloxy)carbonyl]carbamimidoyl]phenyl]amino]acetyl]amino]benzoate; BIBR 953 Impurity; Pradaxa Impurity 73; Dabigatran Process Impurity; 1H-Benzimidazole-5-carboxylic acid, 2-[[(4-carbamimidoylphenyl)amino]methyl]-1-methyl-, ethyl ester, hydrochloride (1:1) (related)
EINECS	Contact for details

Quality Control

Our Dabigatran Impurity 73 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, residual solvent analysis (GC), and structural confirmation (NMR, MS) to ensure identity and purity. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting all test results against predefined specifications. We support compliance with ICH Q3A/B guidelines and cGMP standards for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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