Description

Saxagliptin Impurity CAS NO 2173146-35-3 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Saxagliptin. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) laboratories.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Saxagliptin API batches.
• Method Development and Validation: Essential for developing and validating robust analytical methods, such as HPLC and UPLC, for impurity detection.
• Quality Control & Assurance (QC/QA): Serves as a primary standard in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products in Saxagliptin formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and properties of Saxagliptin-related substances.

Basic Information

Product Name	Saxagliptin Impurity
CAS No.	2173146-35-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Saxagliptin Related Compound; Saxagliptin Impurity Standard; Saxagliptin Specified Impurity; (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile impurity; BMS-477118 Impurity; Onglyza Impurity; UNII-7V0R2S6JQH (related); Saxagliptin EP Impurity
EINECS	Contact for details

Quality Control

Our Saxagliptin Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your regulatory and quality needs.

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 (moisture-sensitive) nature, the container must be kept tightly sealed 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 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.