Description

Apixaban-13C-D3 is a stable isotope-labeled analog of the direct oral anticoagulant Apixaban, specifically designed for use as an internal standard in quantitative bioanalytical methods. This high-purity reference material is essential for ensuring the accuracy, precision, and reliability of pharmacokinetic and pharmacodynamic studies. It is a critical tool for pharmaceutical R&D laboratories, clinical research organizations, and regulatory bodies involved in drug development and therapeutic drug monitoring for anticoagulant therapies.

Application

• Liquid Chromatography-Mass Spectrometry (LC-MS/MS) Internal Standard: Primary use as a stable isotope-labeled internal standard for the precise quantification of Apixaban in biological matrices (plasma, serum, urine).
• Pharmacokinetic and Bioequivalence Studies: Enables accurate measurement of drug concentration-time profiles to assess absorption, distribution, metabolism, and excretion (ADME).
• Clinical Research and Therapeutic Drug Monitoring (TDM): Supports the development and validation of robust assays for monitoring patient drug levels to optimize efficacy and safety.
• Drug Metabolism and Disposition Research: Used in metabolite identification and profiling studies due to its distinct mass spectral signature.
• Regulatory Submission and Compliance: Provides the traceability and method validation data required for submissions to agencies like the FDA and EMA.
• Quality Control in Pharmaceutical Manufacturing: Can be utilized in analytical methods for assessing the purity and stability of Apixaban drug substance and product.

Basic Information

Item	Detail
Product Name	Apixaban-13C-D3
CAS No.	1261393-15-0
Molecular Formula	C25H2213C D3N5O4
Molecular Weight	~ 464.50 g/mol
Synonyms	1-(4-Methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide-13C-D3; BMS-562247-01-13C-D3; Eliquis-13C-D3 (labeled analog); Apixaban (phenyl-13C6, D3); Deuterated and Carbon-13 Labeled Apixaban; Stable Isotope-Labeled Apixaban
EINECS	Contact for details

Quality Control

Every batch of Apixaban-13C-D3 is manufactured and analyzed under strict quality systems. We provide comprehensive analytical data to support its use in regulated environments, including Certificates of Analysis (COA) detailing isotopic purity, chemical purity, and identity confirmation. Our quality commitment ensures compliance with the rigorous standards expected in pharmaceutical research and development.

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 compound is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 99 atom % 13C; ≥ 98 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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