Description

Vardenafil Impurity 15 is a designated impurity associated with the active pharmaceutical ingredient Vardenafil. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories to ensure the purity, safety, and efficacy of Vardenafil-based drug products. The availability of a well-characterized impurity standard is essential for meeting stringent global regulatory requirements for drug substance and drug product specifications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Vardenafil Impurity 15 in drug substances and finished products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (e.g., HPLC, UPLC) to separate and detect this specific impurity.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity profiles and ensure compliance with International Council for Harmonisation (ICH) guidelines on impurities in new drug substances (Q3A(R2)) and products (Q3B(R2)).
• Stability Studies: Used to track the formation of this impurity over time under various stress conditions (e.g., heat, humidity, light) as part of drug product stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CTA) to establish impurity limits and justify the control strategy.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during the synthesis of Vardenafil, enabling process optimization to minimize its generation.

Basic Information

Item	Detail
Product Name	Vardenafil Impurity 15
CAS No.	448184-54-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vardenafil Related Compound 15; Vardenafil EP Impurity I; 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(3H)-one Impurity; Vardenafil Process Impurity; Levitra Impurity 15; Vardenafil Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Vardenafil Impurity 15 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability. Our quality commitment aligns with cGMP principles and supports compliance with pharmacopoeial standards (USP, EP, BP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), in a dry environment. Keep the container sealed to protect the contents from moisture and atmospheric contaminants. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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