Description

Dabigatran Impurity L 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 anticoagulant 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.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Dabigatran Etexilate API and finished dosage forms.
• Essential for analytical method development and validation (HPLC, LC-MS) in quality control (QC) laboratories.
• Used in stability studies to monitor impurity profiles and degradation pathways of Dabigatran-based products.
• Critical for regulatory submissions (e.g., ANDA, NDA) to meet ICH guidelines on impurities in new drug substances (Q3A(R2)).
• Supports research and development activities focused on the synthesis, metabolism, and pharmacokinetics of Dabigatran.
• Employed in pharmacopoeial testing to verify compliance with monograph specifications from USP, EP, or other pharmacopoeias.

Basic Information

Product Name	Dabigatran Impurity L
CAS No.	1422435-41-3
Molecular Formula	C25H25N7O3
Molecular Weight	471.51 g/mol
Synonyms	Dabigatran Related Compound L; Dabigatran Etexilate Impurity L; Ethyl 3-[[2-[[[4-[[[(Hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoate; BIBR 953 Impurity L; BIBR 1048 Impurity L
EINECS	Contact for details

Quality Control

Our Dabigatran Impurity L is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH and cGMP guidelines.

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 desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
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%

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