Description

Alogliptin-D3 is a deuterium-labeled analog of the antidiabetic drug Alogliptin, specifically designed for use as an internal standard in quantitative bioanalytical research. This high-purity reference material is critical for ensuring the accuracy and reliability of pharmacokinetic and metabolic studies through advanced techniques like LC-MS/MS. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions focused on diabetes drug development and analytical method validation.

Application

• Internal Standard for LC-MS/MS Analysis: Primary use as a stable isotope-labeled internal standard for the precise quantification of Alogliptin in biological matrices (plasma, serum, urine).
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Drug Metabolism Research: Facilitates the identification and quantification of drug metabolites in metabolic stability and profiling assays.
• Bioanalytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating robust analytical methods compliant with FDA and ICH guidelines.
• Clinical Trial Support: Used in bioanalysis for therapeutic drug monitoring and efficacy studies during clinical trials for diabetes treatments.
• Quality Control in Reference Material Production: Acts as a reference compound for calibrating instruments and verifying the purity of non-labeled Alogliptin batches.

Basic Information

Product Name	Alogliptin-D3
CAS No.	1133421-35-8
Molecular Formula	C18H18D3N5O2
Molecular Weight	324.41 g/mol
Synonyms	2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)-4-fluorobenzonitrile-d3; Alogliptin (D3); Alogliptin-d3; Deuterated Alogliptin; SYR-322-d3; Nesina-d3 (labeled); (R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile-d3
EINECS	Contact for details

Quality Control

Our Alogliptin-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 enrichment, chemical purity, and identity confirmation via advanced spectroscopic methods. We adhere to cGMP principles for reference standards, supporting research that meets global regulatory standards (ICH, FDA).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or CoA. This compound is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (Mass Spectrometry)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Enrichment)	≥ 98.0 atom % D
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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