Description

Vildagliptin Impurity Za6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antidiabetic drug Vildagliptin by serving as a key marker in impurity profiling and method validation studies. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Vildagliptin Za6 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity detection in Vildagliptin.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs).
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Vildagliptin formulations.
• Research & Development: Serves as a critical reagent in pharmaceutical R&D for studying the degradation pathways and metabolism of Vildagliptin.

Basic Information

Product Name	Vildagliptin Impurity Za6
CAS No.	2246354-69-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vildagliptin Related Compound Za6; Vildagliptin Za6; Vildagliptin Impurity 6; (S)-1-[2-(3-Hydroxyadamantan-1-yl)amino]acetyl]pyrrolidine-2-carbonitrile Impurity Za6; LAF237 Impurity Za6; Galvus Impurity Za6; Zafatek Impurity Za6; DPP-4 Inhibitor Impurity Za6
EINECS	Contact for details

Quality Control

Our Vildagliptin Impurity Za6 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques like HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) detailing all test results is provided 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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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