Description

Dabigatran 13C6 is a stable isotope-labeled analog of the direct thrombin inhibitor Dabigatran, where six carbon atoms are replaced with the 13C isotope. This compound is an essential reference standard and internal standard for the accurate quantification and pharmacokinetic study of Dabigatran and its metabolites using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities engaged in bioanalytical method development, clinical trial sample analysis, and drug metabolism research.

Application

• Bioanalytical Method Development: Serves as a critical internal standard for the development and validation of sensitive and specific LC-MS/MS methods for Dabigatran quantification in biological matrices (plasma, serum, urine).
• Clinical Pharmacology & Pharmacokinetics (PK): Enables precise measurement of Dabigatran concentration in patient samples during clinical trials, supporting studies on bioavailability, bioequivalence, dose-response, and therapeutic drug monitoring.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in absorption, distribution, metabolism, and excretion (ADME) studies to track and quantify the parent drug and potentially its metabolites, correcting for matrix effects and instrument variability.
• Forensic and Toxicological Analysis: Provides a reliable standard for the confirmatory analysis of Dabigatran in forensic or overdose cases, ensuring high accuracy and legal defensibility of results.
• Manufacturing Quality Control: Can be utilized as a reference standard in the quality control of Dabigatran active pharmaceutical ingredient (API) or finished drug product manufacturing to ensure assay accuracy.
• Regulatory Submissions: Supports data packages submitted to health authorities (e.g., FDA, EMA) by providing traceable and definitive quantification data, which is a requirement for new drug applications (NDAs).

Basic Information

Product Name	Dabigatran 13C6
CAS No.	1210608-88-0
Molecular Formula	C25H2513C6N7O3
Molecular Weight	~ 477.51 g/mol (for 13C6 labeled form)
Synonyms	Dabigatran-13C6; BIBR 953 ZW-13C6; Ethyl 3-[(2-{[(4-{[(hexyloxy)carbonyl]amino}phenyl)carbonyl]amino}-5-{[(13C6-cyclohexyl)oxy]carbonyl}phenyl)amino]propanoate-13C6; 1-Methylethyl (2S)-2-{[(4-{[(hexyloxy)carbonyl]amino}phenyl)carbonyl]amino}-3-{3-({[(13C6-cyclohexyl)oxy]carbonyl}amino)phenyl}propanoate-13C6; BIBR 1048 MS Standard-13C6; Dabigatran Etexilate Impurity Standard-13C6; Pradaxa Internal Standard-13C6
EINECS	Contact for details

Quality Control

Every batch of Dabigatran 13C6 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to ensure the product meets the high standards required for quantitative mass spectrometry. This includes verification of isotopic purity (enrichment), chemical purity, and identity. A detailed Certificate of Analysis (COA) is supplied with each shipment, containing batch-specific results from NMR (1H, 13C), HPLC, and LC-MS. Our quality protocols are designed to support compliance with GMP/GLP principles for use in regulated studies.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive). The container should be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (13C6)	≥ 99 atom % 13C
Chemical Purity (NMR)	Conforms to structure, no significant impurities
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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