Description

Saxagliptin Impurity 15 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and manufacturing of the antidiabetic drug Saxagliptin. It serves as a key marker for ensuring the purity, safety, and regulatory compliance of the active pharmaceutical ingredient (API). This impurity standard is essential for analytical chemists, quality assurance professionals, and researchers in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Saxagliptin API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies & Forced Degradation: Used to monitor impurity profiles in Saxagliptin formulations under various stress conditions to establish shelf life.
• Process Chemistry & Optimization: Helps chemists identify and control the formation of this specific impurity during the API synthesis and purification stages.
• Academic & Contract Research: Serves as a research tool in universities and CROs for metabolic studies, impurity synthesis pathways, and analytical research.

Basic Information

Product Name	Saxagliptin Impurity 15 Hcl
CAS No.	2173146-02-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Saxagliptin Related Compound 15 Hydrochloride; Saxagliptin Impurity 15 Hydrochloride; BMS-477118 Impurity 15 HCl; (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile Hydrochloride (Impurity); Saxagliptin EP Impurity H HCl; Saxagliptin USP Impurity; Saxagliptin Process Impurity 15 HCl
EINECS	Contact for details

Quality Control

Every batch of Saxagliptin Impurity 15 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards and relevant pharmacopeial guidelines (e.g., USP, EP, ICH Q3A/B). Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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