Description

[15N,2H2]-Saxagliptin Hydrochloride CAS NO 1309934-06-2 is a stable isotope-labeled analog of the antidiabetic drug Saxagliptin, specifically deuterated and enriched with nitrogen-15. This compound is a critical tool for quantitative bioanalytical research, enabling precise pharmacokinetic and metabolic studies through mass spectrometry. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in drug metabolism and pharmacodynamics (DMPK) research.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a high-purity, non-interfering internal standard for the accurate quantification of Saxagliptin and its metabolites in biological matrices like plasma and urine.
• Drug Metabolism Studies (DMPK): Used to trace and elucidate metabolic pathways, identify metabolites, and study the absorption, distribution, metabolism, and excretion (ADME) profile of Saxagliptin.
• Pharmacokinetic (PK) Profiling: Enables precise measurement of drug concentration over time in preclinical and clinical studies to determine key PK parameters.
• Bioequivalence and Bioanalytical Method Development: Essential for developing and validating robust, regulatory-compliant analytical methods for generic drug applications.
• Stable Isotope Labeling in Medicinal Chemistry: Used as a tracer in mechanistic studies to understand drug-receptor interactions and biochemical pathways.
• Quality Control Reference Material: Acts as a certified reference standard for ensuring the accuracy and precision of analytical assays in quality control laboratories.

Basic Information

Product Name	[15N,2H2]-Saxagliptin Hydrochloride
CAS No.	1309934-06-2
Molecular Formula	C18H23D2N15N O5 • HCl
Molecular Weight	~ 424.9 g/mol (for monoisotopic)
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-15N,d2 Hydrochloride; BMS-477118-15N,d2; Onglyza-15N,d2; Deuterated Saxagliptin Hydrochloride; Nitrogen-15 Labeled Saxagliptin HCl; Saxagliptin D2-15N HCl; Stable Isotope-Labeled Saxagliptin HCl.
EINECS	Contact for details

Quality Control

Every batch of [15N,2H2]-Saxagliptin Hydrochloride is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity, with comprehensive testing including HPLC for chemical purity, NMR and MS for structural and isotopic confirmation, and residual solvent analysis. Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to in-house reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to expected m/z
Purity (HPLC)	≥ 98.0%
Isotopic Purity (15N)	≥ 98 atom %
Isotopic Purity (Deuterium, 2H)	≥ 98 atom % D
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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