Description

Vardenafil Oxopiperazine (Impurity) is a structurally defined degradation product and synthetic intermediate associated with the phosphodiesterase type 5 (PDE5) inhibitor vardenafil. It serves as a critical reference standard for analytical method development, stability studies, and quality control of vardenafil-based pharmaceuticals. Regulatory agencies and contract research organizations rely on this impurity to ensure drug substance purity, compliance with ICH Q3A(R2) guidelines, and accurate quantification of process-related and degradation impurities. Pharmaceutical manufacturers, API suppliers, and QC laboratories engaged in vardenafil synthesis, formulation, or regulatory filing are the primary users of this high-integrity chemical standard.

Application

• Reference standard for HPLC and UPLC method validation in vardenafil API and finished dosage form testing
• Calibration material for quantitative determination of vardenafil-related impurities per ICH Q5R1 and Q3A(R2)
• Stability-indicating assay component for forced degradation studies (oxidative, photolytic, thermal)
• Qualification of unknown peaks observed during vardenafil manufacturing process validation
• Supporting documentation for regulatory submissions to FDA, EMA, PMDA, and Health Canada
• Use in pharmacopeial compliance testing (USP-NF, Ph. Eur., JP) for vardenafil monographs
• Research tool for structure-activity relationship (SAR) studies of piperazine-containing PDE5 inhibitors
• Raw material for synthesizing additional vardenafil-related impurity standards and metabolites

Basic Information

Product Name	Vardenafil Oxopiperazine (Impurity)
CAS No.	448184-58-5
Molecular Formula	C22H27N5O3
Molecular Weight	409.49 g/mol
Synonyms	Vardenafil N-Oxopiperazine; Vardenafil Oxopiperazine Impurity A; N-(4-ethoxy-3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-1H-indazol-1-yl)oxopiperazine; Vardenafil 1-Oxopiperazine Adduct; Vardenafil Oxopiperazine Degradant; 1-((4-Ethoxy-3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-1H-indazol-1-yl)carbonyl)oxopiperazine; Vardenafil Piperazine Ring-Oxidized Impurity
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. Each batch is verified for identity (IR, HPLC retention time match), purity (≥98.5% by HPLC), and absence of residual solvents and heavy metals per ICH Q3C and Q3D guidelines. Testing is performed in accordance with ISO/IEC 17025-accredited methods, supporting regulatory filings and GMP-aligned quality systems.

Storage

Preserve in a tightly closed container, protected from light. Store at 15–25°C in a dry, well-ventilated area. Due to its light-sensitive nature, minimize exposure to ambient and UV light during handling and storage.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.5% – 101.0%
Related Substances (HPLC)	Single impurity ≤0.3%; Total impurities ≤0.5%
Residual Solvents (GC)	Meets ICH Q3C limits
Heavy Metals (ICP-MS)	≤10 ppm
Water (Karl Fischer)	≤0.5%

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