Description

Saxagliptin Impurity 15 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for the accurate identification, quantification, and monitoring of process-related impurities in the active pharmaceutical ingredient Saxagliptin, an antidiabetic medication. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, ensuring drug safety and regulatory compliance. The product is supplied with comprehensive analytical data to support method validation and regulatory filings.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the calibration of analytical instruments (HPLC, LC-MS) in quality control laboratories.
• Method Development and Validation: Crucial for developing and validating stability-indicating analytical methods for Saxagliptin drug substance and finished products.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity profiles and specifications.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Saxagliptin.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Saxagliptin to minimize the formation of this impurity.
• Quality Assurance Testing: Employed in routine batch release testing to ensure Saxagliptin API and drug products meet stringent purity specifications.

Basic Information

Item	Details
Product Name	Saxagliptin Impurity 15
CAS No.	1496712-39-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Saxagliptin Related Compound 15; Saxagliptin EP Impurity J; Saxagliptin USP 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 15; Onglyza Impurity 15
EINECS	Contact for details

Quality Control

Every batch of Saxagliptin Impurity 15 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the exact specifications and test results for traceability and compliance.

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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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