Description

Saxagliptin CAS NO 361442-04-8 is a potent and selective dipeptidyl peptidase-4 (DPP-4) inhibitor, representing a critical active pharmaceutical ingredient (API) in the treatment of type 2 diabetes. Its primary value lies in its ability to enhance glycemic control by increasing the body's levels of incretin hormones, which stimulate insulin release in a glucose-dependent manner. This compound is essential for pharmaceutical manufacturers engaged in the development and production of antidiabetic medications, particularly for formulating oral tablets.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of saxagliptin hydrochloride tablets (e.g., Onglyza®).
• Antidiabetic Drug Formulation: Formulation of oral solid dosage forms for the management of type 2 diabetes mellitus.
• Fixed-Dose Combination Drugs: Used in combination with other antidiabetic agents like metformin for enhanced therapeutic effect.
• Research & Development: Serves as a reference standard and key intermediate in metabolic disease research and new drug discovery.
• Generic Drug Manufacturing: Critical for generic pharmaceutical companies producing bioequivalent versions of branded saxagliptin products.

Basic Information

Item	Detail
Product Name	Saxagliptin
CAS No.	361442-04-8
Molecular Formula	C18H25N3O2
Molecular Weight	315.41 g/mol
Synonyms	(1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile; BMS-477118; Onglyza (as the hydrochloride salt); Saxagliptin Base; DPP-4 Inhibitor BMS-477118
EINECS	Contact for details

Quality Control

Our Saxagliptin is manufactured under strict quality systems to meet the rigorous standards of the global pharmaceutical industry. We ensure compliance with ICH Q7 guidelines and relevant pharmacopeial requirements. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, identity, and impurity profiles to support your regulatory filings and quality assurance processes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm

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