Description

Vildagliptin Impurity 34 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes for the antidiabetic drug Vildagliptin. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification, quantification, and control during manufacturing. It is an essential material for analytical chemists, quality assurance professionals, and researchers in pharmaceutical R&D and quality control laboratories focused on metabolic disease therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Vildagliptin Impurity 34 in active pharmaceutical ingredient (API) and finished drug product batches.
• Analytical Method Development & Validation: Critical component for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods for Vildagliptin.
• Stability Studies & Degradation Profiling: Used to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure impurity levels in commercial Vildagliptin API comply with stringent pharmacopeial (USP, EP) and ICH Q3A/B limits.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Process Chemistry Research: Aids in understanding and optimizing the Vildagliptin synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Vildagliptin Impurity 34
CAS No.	1824265-77-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vildagliptin Related Compound 34; LAF237 Impurity 34; (S)-1-[2-(3-Hydroxyadamantan-1-ylamino)acetyl]pyrrolidine-2-carbonitrile Impurity; NVP-LAF-237 Impurity 34; Galvus Impurity 34; 2-Cyanopyrrolidine Impurity; Dipeptidyl Peptidase-4 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Vildagliptin Impurity 34 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment 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 compound is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to 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 Q3C

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