Description

Vardenafil Impurity 5 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Vardenafil, a medication used to treat erectile dysfunction. It is an essential tool for pharmaceutical manufacturers, research institutions, and regulatory bodies involved in drug development and quality assurance. The precise characterization of this impurity is vital for meeting stringent global pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Vardenafil Impurity 5 in API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Studies & Forced Degradation: Used to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profile data for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure every batch of Vardenafil API complies with specified impurity limits (e.g., ICH guidelines).
• Research & Development: Used in R&D to study the degradation pathways of Vardenafil and to synthesize purer forms of the API.

Basic Information

Product Name	Vardenafil Impurity 5
CAS No.	927690-90-2
Molecular Formula	C23H32N6O4S
Molecular Weight	488.61 g/mol
Synonyms	Vardenafil Related Compound 5; Vardenafil EP Impurity 5; Vardenafil USP Impurity 5; (2R,3R,5S)-2-(2-Ethoxy-5-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propyl-3,7-dihydro-3H-pyrrolo[3,2-d]pyrimidin-4-one; Levitra Impurity 5; Nuviva Impurity 5
EINECS	Contact for details

Quality Control

Every batch of Vardenafil Impurity 5 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with current pharmacopeial standards (USP, EP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results from advanced analytical techniques including HPLC, LC-MS, NMR, and IR spectroscopy.

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) and should 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
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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