Description

Teriflunomide-D4 is a stable isotope-labeled analog of the active metabolite of leflunomide, where four hydrogen atoms are replaced by deuterium. This high-purity reference standard is critical for ensuring the accuracy and reliability of quantitative mass spectrometry analyses in pharmaceutical research and development. It is an essential tool for scientists in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors who require precise internal standards for pharmacokinetic studies, bioanalytical method development, and metabolic profiling.

Application

• Internal Standard for LC-MS/MS: Primary use as a quantitative internal standard in liquid chromatography-tandem mass spectrometry (LC-MS/MS) bioanalysis for Teriflunomide and related compounds.
• Pharmacokinetic and Metabolism Studies: Enables accurate tracking and quantification of Teriflunomide in biological matrices (plasma, serum, urine) during drug metabolism and pharmacokinetics (DMPK) research.
• Bioanalytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Drug Impurity Profiling and Characterization: Aids in the identification and quantification of potential impurities or degradants in active pharmaceutical ingredient (API) batches.
• Clinical Trial Support: Used in the bioanalysis of samples from clinical trials to ensure data integrity for regulatory submissions.
• Stable Isotope Dilution Assays: Employed in high-precision assays where the deuterated analog compensates for matrix effects and instrument variability.

Basic Information

Product Name	Teriflunomide-D4
CAS No.	1185240-22-5
Molecular Formula	C12H5D4F3N2O2
Molecular Weight	274.22 g/mol (for C12H5D4F3N2O2)
Synonyms	2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]-2-butenamide-d4; (Z)-2-Cyano-3-hydroxy-but-2-enoic acid (4-trifluoromethyl)-anilide-d4; A77 1726-d4 (deuterated metabolite of Leflunomide); Deuterated Teriflunomide; Teriflunomide (D4); [2H4]-Teriflunomide
EINECS	Contact for details

Quality Control

Every batch of Teriflunomide-D4 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 analytical applications. Certificates of Analysis (COA) are supplied with each shipment, detailing critical parameters such as isotopic purity, chemical purity, and absence of interfering impurities. Our quality protocols are designed to support compliance with cGMP and ICH Q7 guidelines where applicable.

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). For long-term storage, consider desiccation and storage under inert atmosphere to maintain optimal stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0% (Chemical Purity)
Isotopic Purity (D-content)	≥98.0 atom % D
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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