Description

Saxagliptin Impurity 52 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Saxagliptin, an antidiabetic medication. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by providing a benchmark for identification and quantification. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Saxagliptin API and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to ensure Saxagliptin meets specified purity limits as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to monitor the formation and level of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug shelf-life studies.
• Regulatory Submissions: Provides necessary data for impurity characterization reports required by regulatory bodies like the FDA, EMA, and PMDA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purer synthetic routes for Saxagliptin.

Basic Information

Product Name	Saxagliptin Impurity 52
CAS No.	1091626-35-5
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 Impurity 52; Saxagliptin Related Compound 52; Onglyza Impurity 52; (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

Every batch of Saxagliptin Impurity 52 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your regulatory and quality 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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.