Description

n-Desethyl-n-Methyl Vardenafil is a key pharmaceutical intermediate and reference standard in the development and quality control of active pharmaceutical ingredients (APIs). This compound is of significant importance for ensuring the purity, potency, and regulatory compliance of related therapeutic agents. It is primarily required by pharmaceutical R&D laboratories, API manufacturers, and analytical testing facilities for synthesis, method validation, and impurity profiling.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of advanced active pharmaceutical ingredients (APIs).
• Reference Standard: Used for analytical method development, validation, and calibration in quality control laboratories.
• Impurity Standard: Essential for the identification and quantification of related substances and degradation products in drug substances and finished products.
• Research Chemical: Employed in preclinical and clinical research studies to investigate pharmacological profiles and metabolic pathways.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing characterized materials for stability studies and specification setting.

Basic Information

Product Name	n-Desethyl-n-Methyl Vardenafil
CAS No.	224785-87-9
Molecular Formula	C25H36N6O4S
Molecular Weight	516.66 g/mol
Synonyms	N-Desethyl-N-methylvardenafil; N-Desethyl-N-methyl Vardenafil; Vardenafil Impurity; Vardenafil Related Compound; 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 Methyl Vardenafil
EINECS	Contact for details

Quality Control

Our n-Desethyl-n-Methyl Vardenafil is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to ensure high purity and structural identity. Certificates of Analysis (COA) detailing all test results are provided and can be tailored to meet specific pharmacopeial or internal standards upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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