Description

Saxagliptin o-β-D-Glucuronide is a key metabolite and reference standard of the antidiabetic drug saxagliptin. This high-purity compound is critical for pharmaceutical research and development, particularly in the study of drug metabolism and pharmacokinetics (DMPK). It is primarily utilized by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in bioanalytical method development, metabolite identification, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the quantitative and qualitative analysis of saxagliptin and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, clearance mechanisms, and exposure levels of saxagliptin in preclinical and clinical studies.
• Bioanalytical Method Development and Validation: Used as a critical reagent in developing and validating LC-MS/MS, HPLC, and other analytical methods for pharmacokinetic assays.
• Impurity Profiling and Control: Acts as a specified impurity or degradation product standard to ensure the quality and safety of saxagliptin active pharmaceutical ingredient (API) and finished drug products.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for a major human metabolite.
• Toxicology and Safety Assessment: Employed in studies to understand the safety profile and potential biological activity of saxagliptin metabolites.

Basic Information

Product Name	Saxagliptin o-β-D-Glucuronide
CAS No.	1155849-58-3
Molecular Formula	C21H27N3O9
Molecular Weight	465.46 g/mol
Synonyms	(1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile o-β-D-Glucuronide; BMS-477118 o-β-D-Glucuronide; Saxagliptin Major Metabolite M2; Saxagliptin Glucuronide; Onglyza Metabolite; (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile β-D-glucopyranosiduronic acid
EINECS	Contact for details

Quality Control

Our Saxagliptin o-β-D-Glucuronide is manufactured under strict quality systems to ensure it meets the exacting requirements for pharmaceutical reference standards. Each batch is subjected to comprehensive analytical characterization using techniques including HPLC, LC-MS, and NMR to confirm identity, purity, and stability. Certificates of Analysis (COA) are provided, detailing batch-specific results. We support compliance with ICH guidelines for impurities and can supply material suitable for use in GLP/GMP-regulated environments.

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) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
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.