Description

Vardenafil Impurity 7 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 HCl. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing. The availability of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Vardenafil Impurity 7 in Vardenafil API and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Batch Release: Essential for routine quality control testing to ensure API batches meet specified impurity limits as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to determine product shelf-life.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to demonstrate control strategy.
• Research & Development: Used in synthetic chemistry R&D to understand and mitigate the formation pathway of this impurity during API synthesis.

Basic Information

Product Name	Vardenafil Impurity 7
CAS No.	448184-56-3
Molecular Formula	C23H32N6O4S
Molecular Weight	488.61 g/mol
Synonyms	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; Desethyl Vardenafil; Vardenafil N-Deethyl Impurity; Vardenafil Related Compound; Levitra Impurity; N-Deethyl Vardenafil; Vardenafil EP Impurity G; Vardenafil USP Impurity
EINECS	Contact for details

Quality Control

Our Vardenafil Impurity 7 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis (GC), and structural confirmation (NMR, MS). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results against established specifications. Our quality standards align with ICH guidelines and support compliance requirements for cGMP manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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