Description

(2S,2’R,Cis)-7-Hydroxy-Saxagliptin is a key pharmaceutical intermediate and metabolite of the antidiabetic drug Saxagliptin. This compound is of significant importance for research and development in the pharmaceutical industry, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of related active pharmaceutical ingredients (APIs). It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and academic research institutions focused on metabolic disease therapeutics and analytical method development.

Application

• Pharmaceutical Intermediate: Critical for the synthesis and scale-up of Saxagliptin and its derivative compounds.
• Metabolite Reference Standard: Used as an analytical standard in bioanalytical studies to quantify the 7-hydroxy metabolite in biological matrices for pharmacokinetic profiling.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Essential for in vitro and in vivo studies to understand the metabolic pathways and clearance mechanisms of Saxagliptin.
• Impurity Profiling: Serves as a certified reference material for identifying and quantifying related substances and degradation products in Saxagliptin drug substance and finished dosage forms.
• Process Development & Validation: Utilized in the development and validation of manufacturing processes for Saxagliptin API to ensure consistency and control.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., FDA, EMA) supporting drug safety and efficacy.

Basic Information

Product Name	(2S,2’R,Cis)-7-Hydroxy-Saxagliptin
CAS No.	1795791-40-0
Molecular Formula	C18H25N3O4
Molecular Weight	347.41 g/mol
Synonyms	7-Hydroxy Saxagliptin; (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, 7-Hydroxy derivative; BMS-477118 metabolite; Saxagliptin Hydroxy Metabolite; (2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetic acid - (1S,3S,5S)-2-azabicyclo[3.1.0]hexane-3-carbonitrile (1:1); ONGLYZA metabolite
EINECS	Contact for details

Quality Control

Our (2S,2’R,Cis)-7-Hydroxy-Saxagliptin is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets high-purity standards suitable for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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