Description

Hydroxy Saxagliptin-15N,D2 Hydrochloride is a stable isotope-labeled analog of a key pharmaceutical intermediate. This compound is essential for conducting advanced pharmacokinetic and metabolic studies, providing critical data for drug development and regulatory submissions. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in the development and quality control of saxagliptin-based therapies.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a critical reference standard in quantitative bioanalytical methods for accurate measurement of saxagliptin and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used in mass spectrometry-based assays to trace metabolic pathways, study absorption, distribution, metabolism, and excretion (ADME), and assess bioavailability.
• Pharmaceutical Impurity Profiling and Characterization: Aids in the identification and quantification of process-related impurities and degradation products during drug substance development.
• Clinical Research and Biomarker Analysis: Enables precise tracking of drug levels in patient samples during clinical trials to establish dose-response relationships.
• Stable Isotope Dilution Assays: Provides high accuracy and precision in quantitative analyses by minimizing matrix effects and instrumental variability.

Basic Information

Product Name	Hydroxy Saxagliptin-15N,D2 Hydrochloride
CAS No.	1309934-05-1
Molecular Formula	C18H23D2 15NN3O2•HCl
Molecular Weight	~ 368.90 g/mol
Synonyms	(1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile-15N,D2 Hydrochloride; Saxagliptin Hydroxy Metabolite-15N,D2 HCl; BMS-510849-15N,D2 Hydrochloride; (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile-15N,D2 Hydrochloride; 5-Hydroxy Saxagliptin-15N,D2 HCl; Stable Isotope Labeled Saxagliptin Metabolite
EINECS	Contact for details

Quality Control

Every batch of Hydroxy Saxagliptin-15N,D2 Hydrochloride is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and isotopic enrichment meet the highest standards for research use. Our quality protocols are designed to support GLP/GMP-compliant workflows. A comprehensive Certificate of Analysis (COA), detailing results for assay, isotopic purity, chemical purity (by HPLC), and identification (NMR, MS), is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. Due to its hygroscopic nature, the container should be kept sealed under an inert atmosphere (e.g., nitrogen or argon) after opening to maintain long-term stability and prevent moisture absorption.

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 (15N)	≥ 98 atom %
Isotopic Purity (D)	≥ 98 atom %
Assay (Titration)	97.0% - 103.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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