Description

Saxagliptin Impurity 1 is a specified impurity and degradation product of the antidiabetic pharmaceutical agent Saxagliptin. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, quality control, and compliance purposes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Saxagliptin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Saxagliptin.
• Quality Control (QC) Testing: Serves as a system suitability standard and for routine batch release testing in pharmaceutical QC laboratories.
• Regulatory Compliance & Documentation: Used to prepare impurity profiles for regulatory submissions (e.g., to FDA, EMA) and to establish specification limits in line with ICH Q3A/B guidelines.
• Research & Development: Utilized in synthetic chemistry research to study the formation and fate of this specific impurity during the manufacturing process.

Basic Information

Product Name	Saxagliptin Impurity 1
CAS No.	1564266-73-4
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; Saxagliptin Related Compound; BMS-477118 Impurity; Onglyza Impurity; (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile
EINECS	Contact for details

Quality Control

Our Saxagliptin Impurity 1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmaceutical impurity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results 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). This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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