Description

Dabigatran Impurity 16 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 anticoagulant active pharmaceutical ingredient (API) Dabigatran Etexilate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine quality control testing. The product is supplied with comprehensive analytical data to support its use in GMP environments.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Dabigatran Etexilate API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in pharmaceutical R&D and QC laboratories.
• Quality Control & Batch Release: Employed in routine impurity profiling to ensure API batches meet pharmacopeial (e.g., USP, EP) and internal specification limits.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Used to monitor the formation and level of this specific impurity during forced degradation and long-term stability studies of drug products.
• Academic & Clinical Research: Serves as a key reagent in studies investigating the metabolism, pharmacokinetics, and degradation pathways of Dabigatran.

Basic Information

Product Name	Dabigatran Impurity 16
CAS No.	211916-39-1
Molecular Formula	C25H25N7O3
Molecular Weight	471.51 g/mol
Synonyms	Dabigatran Related Compound 16; BIBR 953 Impurity 16; Ethyl 3-[(2-{[(4-{N'-[(Hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino]propanoate; Dabigatran Etexilate Impurity 16; BIBR 1048 MS Impurity; Pradaxa Impurity 16; 1H-Benzimidazole-5-carboxylic acid, 2-[[[4-[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-, 2-pyridinyl ester
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Impurity 16 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and chromatograms. Our quality commitment aligns with cGMP principles to support our clients' regulatory needs.

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 product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere to ensure 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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% 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.