Description

Saxagliptin Hydrochloride is a high-purity active pharmaceutical ingredient (API) used in the treatment of type 2 diabetes. It functions as a potent and selective dipeptidyl peptidase-4 (DPP-4) inhibitor, helping to regulate blood glucose levels. This compound is essential for pharmaceutical manufacturers developing and producing oral anti-diabetic medications. Consistent quality and reliable supply are critical for ensuring the efficacy and safety of the final drug product.

Application

• Primary active ingredient in the formulation of anti-diabetic tablets and capsules.
• Used in pharmaceutical research and development (R&D) for new diabetes therapies.
• Key component in the manufacture of generic versions of saxagliptin-based medications.
• Reference standard for analytical testing and quality control in pharmaceutical laboratories.
• Used in preclinical and clinical studies for metabolic disorder research.
• Raw material for compounding pharmacies specializing in custom diabetic care formulations.

Basic Information

Product Name	Saxagliptin Hydrochloride
CAS No.	709031-78-7
Molecular Formula	C18H25N3O2 • HCl
Molecular Weight	351.87 g/mol (for free base: 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 hydrochloride; BMS-477118; Onglyza (Brand Name); Saxagliptin HCl; Saxagliptin Monohydrochloride
EINECS	Contact for details

Quality Control

Our Saxagliptin Hydrochloride is manufactured under strict quality systems. It undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, identity, and impurity profiles. Our quality commitment aligns with ICH guidelines and current Good Manufacturing Practices (cGMP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches 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.