Description

Saxagliptin o-Sulfate CAS NO 1429782-94-4 is a high-purity pharmaceutical intermediate, specifically the sulfate salt of a key metabolite of the antidiabetic drug Saxagliptin. This compound is critical for ensuring the quality, consistency, and regulatory compliance of finished drug products. It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in the development and production of dipeptidyl peptidase-4 (DPP-4) inhibitors for the treatment of type 2 diabetes.

Application

• Primary use as a reference standard and pharmaceutical impurity standard in analytical method development and validation for Saxagliptin drug products.
• Critical intermediate in the synthesis and research of Saxagliptin and its related metabolites.
• Essential material for pharmacological and pharmacokinetic studies to understand drug metabolism and activity.
• Used in quality control (QC) and quality assurance (QA) laboratories to monitor and control impurities in active pharmaceutical ingredient (API) and finished dosage form manufacturing.
• Supports regulatory filings (e.g., for FDA, EMA) by providing characterized materials for stability studies and specification setting.

Basic Information

Product Name	Saxagliptin o-Sulfate
CAS No.	1429782-94-4
Molecular Formula	C18H27N3O7S
Molecular Weight	429.49 g/mol
Synonyms	(1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile sulfate; BMS-477118 sulfate; Saxagliptin metabolite sulfate; Onglyza metabolite sulfate; (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile sulfate salt
EINECS	Contact for details

Quality Control

Our Saxagliptin o-Sulfate is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical testing, including HPLC purity, identification by spectroscopic methods (IR, NMR, MS), and specific impurity profiling. A detailed Certificate of Analysis (COA) is provided with every shipment, ensuring traceability and compliance with cGMP guidelines and ICH regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Heavy Metals	≤ 20 ppm

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