Description

Saxagliptin Impurity 34 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Saxagliptin, a key medication for type 2 diabetes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Saxagliptin API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels during manufacturing.
• Quality Control (QC) & Quality Assurance (QA): Serves as a primary standard in QC laboratories to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation and level of this impurity under various stress conditions to determine drug product shelf life.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Saxagliptin.

Basic Information

Item	Detail
Product Name	Saxagliptin Impurity 34
CAS No.	2173146-31-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Saxagliptin Related Compound 34; Saxagliptin EP Impurity 34; Saxagliptin USP Impurity 34; (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 34; Onglyza Impurity 34; Degradation Product of Saxagliptin
EINECS	Contact for details

Quality Control

Every batch of Saxagliptin Impurity 34 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 ICH guidelines and relevant pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles.

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 must be kept under inert conditions or in a desiccator to maintain stability and purity.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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