Description

Vardenafil Impurity 11 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, a key medication for erectile dysfunction. 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 global pharmacopeial guidelines.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Vardenafil HCl API and finished dosage forms.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in pharmaceutical R&D and QC laboratories.
• Critical component in stability studies to monitor impurity profiles and establish shelf-life for drug products.
• Used for regulatory compliance and submissions to agencies like the US FDA, EMA, and other global health authorities.
• Serves as a system suitability standard in pharmacopeial testing to ensure analytical instrument performance.
• Supports process chemistry optimization by helping to identify and control synthetic by-products.

Basic Information

Product Name	Vardenafil Impurity 11
CAS No.	448184-60-9
Molecular Formula	C23H32N6O4S
Molecular Weight	488.61 g/mol
Synonyms	Vardenafil Related Compound H; Vardenafil EP Impurity H; 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-one; Levitra Impurity H; Nuviva Impurity H
EINECS	Contact for details

Quality Control

Every batch of Vardenafil Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopeial monographs (USP, EP). Comprehensive characterization is performed using advanced techniques like NMR, MS, and HPLC. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under inert conditions to ensure long-term stability.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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