Description

Linagliptin-D3 is a deuterium-labeled analog of the dipeptidyl peptidase-4 (DPP-4) inhibitor Linagliptin, specifically designed for use as an internal standard in quantitative bioanalytical studies. This high-purity, stable isotope-labeled compound is essential for ensuring the accuracy and reliability of pharmacokinetic and metabolism data through mass spectrometry techniques. It is a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control units engaged in the development and validation of analytical methods for antidiabetic drugs.

Application

• Internal Standard for LC-MS/MS: Primary application as a quantitative internal standard in Liquid Chromatography-Tandem Mass Spectrometry for the precise analysis of Linagliptin in biological matrices (plasma, serum, urine).
• Drug Metabolism and Pharmacokinetics (DMPK): Used in ADME (Absorption, Distribution, Metabolism, Excretion) studies to track and quantify the parent drug, improving data accuracy.
• Bioanalytical Method Development & Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Clinical Trial Support: Enables reliable therapeutic drug monitoring and pharmacokinetic profiling during clinical phases of drug development.
• Reference Material for Impurity Testing: Can serve as a reference standard in stability studies and impurity profiling of Linagliptin drug substances and products.

Basic Information

Product Name	Linagliptin-D3
CAS No.	1398044-48-8
Molecular Formula	C25H25D3N8O2
Molecular Weight	473.56 g/mol
Synonyms	8-[(3R)-3-Aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1H-purine-2,6-dione-d3; BI 1356-D3; Tradjenta-D3; (R)-8-(3-Aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione-d3; Deuterated Linagliptin; Linagliptin (methyl-d3); Linagliptin-d3 Internal Standard
EINECS	Contact for details

Quality Control

Our Linagliptin-D3 is manufactured under strict quality control protocols to ensure the highest isotopic purity and chemical integrity required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for isotopic purity (≥99% deuterium incorporation), chemical purity (by HPLC), and identity confirmation (by NMR and MS). We adhere to relevant industry standards for reference materials to support your regulatory submissions.

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 product is hygroscopic (moisture-sensitive). Keep the container tightly sealed in a dry environment to prevent degradation.

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 (NMR/MS)	≥99.0% D (at labeled positions)
Chemical Purity	≥95.0%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH limits

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