Description

Saxagliptin Hydrate CAS NO 945667-22-1 is a high-purity active pharmaceutical ingredient (API) belonging to the dipeptidyl peptidase-4 (DPP-4) inhibitor class. This compound is critical for the formulation of effective oral anti-diabetic medications, offering a targeted mechanism of action for glycemic control. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for type 2 diabetes mellitus.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of anti-diabetic drugs.
• Formulation Development: Used in R&D for creating solid oral dosage forms such as tablets and capsules.
• Reference Standard: Serves as a certified reference material (CRM) for analytical method development and quality control testing in laboratories.
• Clinical Research: Employed in preclinical and clinical studies for new diabetes therapies and combination treatments.
• Generic Drug Manufacturing: Key component for producing bioequivalent generic versions of DPP-4 inhibitor medications.

Basic Information

Item	Details
Product Name	Saxagliptin Hydrate
CAS No.	945667-22-1
Molecular Formula	C18H25N3O2 • xH2O
Molecular Weight	315.41 g/mol (Anhydrous)
Synonyms	Saxagliptin Monohydrate; BMS-477118; (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile Hydrate; Onglyza (Brand Name API); (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile Hydrate
EINECS	Contact for details

Quality Control

Our Saxagliptin Hydrate is manufactured under strict quality management systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical use, with comprehensive analysis for identity, potency, and impurities. A Certificate of Analysis (COA) documenting compliance with relevant specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry 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)	3.0% - 6.0%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	< 20 ppm

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