Description

Vildagliptin Related Compound G is a high-purity reference standard and pharmaceutical intermediate, identified by CAS No. 1616662-84-0. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Vildagliptin, a key medication for type 2 diabetes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in process development, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Vildagliptin API and finished drug products, ensuring compliance with ICH Q3A/B guidelines.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods for quality control (QC) and stability-indicating assays.
• Process Chemistry Research: Serves as a key intermediate or by-product marker in the research and optimization of Vildagliptin synthesis pathways.
• Regulatory Documentation & Submission: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug product stability testing.
• Pharmacopoeial Testing: Used in testing to meet monograph specifications for Vildagliptin in pharmacopoeias such as USP or EP.

Basic Information

Product Name	Vildagliptin Related Compound G
CAS No.	1616662-84-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2S)-1-[2-[(3-Hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carbonitrile; Vildagliptin Impurity G; LAF237 Related Compound G; Galvus Impurity G; NVP-LAF-237 Related Compound G; (S)-1-(2-((3-Hydroxyadamantan-1-yl)amino)acetyl)pyrrolidine-2-carbonitrile; Vildagliptin EP Impurity G
EINECS	Contact for details

Quality Control

Our Vildagliptin Related Compound G is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, and our quality standards align with the requirements for pharmaceutical reference standards. Specifications are designed to meet the needs of regulatory submissions and pharmacopoeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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