Description

Alogliptin-13C,D3 is a stable isotope-labeled analog of the active pharmaceutical ingredient Alogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. This high-purity reference standard is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, particularly Liquid Chromatography-Mass Spectrometry (LC-MS/MS). It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory bodies for use in pharmacokinetic studies, drug metabolism research, and clinical trial sample analysis.

Application

• Internal Standard for LC-MS/MS Quantification: Serves as a critical internal standard for the precise and accurate quantification of Alogliptin in biological matrices such as plasma, serum, and urine.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used in mass spectrometry-based assays to study the absorption, distribution, metabolism, and excretion (ADME) profile of Alogliptin.
• Clinical Trial Bioanalysis: Enables reliable measurement of drug concentration in patient samples during clinical development and therapeutic drug monitoring.
• Method Development and Validation: A key component in developing, optimizing, and validating robust bioanalytical methods compliant with FDA, EMA, and ICH guidelines.
• Quality Control in Pharmaceutical Analysis: Supports quality control procedures in manufacturing environments where trace-level analysis of the drug substance is required.
• Isotope Dilution Mass Spectrometry (IDMS): Employed in high-accuracy IDMS techniques, which are considered a gold standard for reference measurement procedures.

Basic Information

Product Name	Alogliptin-13C,D3
CAS No.	1246817-18-4
Molecular Formula	C₁₈H₁₈D₃¹³CN₅O₂
Molecular Weight	~327.38 g/mol
Synonyms	2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile-13C,D3; Alogliptin (13C,D3 labeled); Alogliptin-13C,d3; Alogliptin isotope; SYR-322-13C,D3; Nesina-13C,D3; DPP-4 Inhibitor-13C,D3; 1-[[(3-Hydroxy-1-adamantyl)amino]acetyl]-2-cyano-(S)-pyrrolidine-13C,D3 (related core structure).
EINECS	Contact for details

Quality Control

Every batch of Alogliptin-13C,D3 is manufactured and analyzed under strict quality systems. We provide comprehensive Certificates of Analysis (COA) that detail isotopic purity (e.g., ≥99% 13C and ≥98% D), chemical purity (typically ≥98% by HPLC), and confirm identity and potency. Our quality commitment aligns with the standards expected for reference materials in regulated bioanalysis, supporting compliance with ICH Q2(R1) and FDA GLP guidelines. Certificates of Analysis are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C, in a dry environment. Due to its hygroscopic nature, the container should be kept in a desiccator or under conditions that minimize exposure to atmospheric moisture. For long-term stability, consider storage at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Consistent with labeled structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (13C)	≥ 99 atom % 13C
Isotopic Purity (D)	≥ 98 atom % D
Chemical Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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