Description

Vardenafil Impurity 1 is a high-purity reference standard used in the pharmaceutical development and quality control of Vardenafil, a key active pharmaceutical ingredient. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by serving as a benchmark for impurity identification and quantification. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers focused on process chemistry and regulatory submissions.

Application

• Primary use as a certified reference standard for the analytical method development and validation of Vardenafil API.
• Critical component in impurity profiling and stability studies to monitor degradation pathways.
• Essential for pharmaceutical quality control (QC) laboratories to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Used in regulatory filing and submission dossiers (e.g., for FDA, EMA) to establish impurity identification and control strategies.
• Valuable for research and development in process chemistry to optimize synthesis routes and minimize impurity formation.
• Supports pharmacopoeial testing and compliance with standards such as USP or EP monographs for Vardenafil.

Basic Information

Product Name	Vardenafil Impurity 1
CAS No.	1417529-67-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vardenafil Related Compound 1; Vardenafil Impurity A; Vardenafil EP Impurity A; 2-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4(3H)-one; Levitra Impurity 1; Nuviva Impurity 1
EINECS	Contact for details

Quality Control

Our Vardenafil Impurity 1 is manufactured under strict quality systems suitable for pharmaceutical reference standards. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to confirm identity and ensure high purity. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the results against stringent internal specifications. We support compliance with ICH Q3A/B guidelines and relevant pharmacopoeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
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.