Description

Vardenafil Impurity 15 is a high-purity reference standard used in the pharmaceutical development and quality control of Vardenafil, a key active pharmaceutical ingredient (API). This compound is critical for ensuring the safety, efficacy, and regulatory compliance of finished drug products by accurately identifying and quantifying related substances. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers focused on impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Vardenafil API and its formulations.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Used to monitor the formation of degradation products in Vardenafil drug substances and products under various stress conditions.
• Process Chemistry Research: Aids in the optimization of Vardenafil synthesis by identifying and tracking process-related impurities.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing to ensure product purity meets pharmacopeial specifications.

Basic Information

Product Name	Vardenafil Impurity 15
CAS No.	1009013-42-6
Molecular Formula	C23H32N6O4S
Molecular Weight	488.61 g/mol
Synonyms	Vardenafil Related Compound 15; Vardenafil EP Impurity I; Vardenafil USP Impurity; 2-[2-Ethoxy-5-[(4-ethylpiperazin-1-yl)sulfonyl]phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4(3H)-one; Levitra Impurity 15; Nuviva Impurity 15
EINECS	Contact for details

Quality Control

Every batch of Vardenafil Impurity 15 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, LC-MS, and NMR, to ensure identity, purity, and stability conform to the highest standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance 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); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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