Description

Desethyl Sildenafil is a key pharmaceutical intermediate and metabolite of the active pharmaceutical ingredient Sildenafil. This compound is of significant importance in the research, development, and quality control of erectile dysfunction and pulmonary arterial hypertension treatments. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for the synthesis of active compounds and as a critical reference standard for impurity profiling and bioanalytical studies.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of Sildenafil and related active pharmaceutical ingredients (APIs).
• Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sildenafil API and finished drug products.
• Metabolite Studies: Essential for pharmacokinetic and pharmacodynamic research to understand the metabolism and activity profile of Sildenafil.
• Analytical Method Development: Serves as a key component in developing and validating HPLC, LC-MS, and other chromatographic methods for quality control.
• Regulatory Compliance: Supports regulatory filings and submissions by providing necessary impurity data to meet ICH Q3A/B guidelines.
• Bioanalytical Research: Employed in clinical and preclinical studies to calibrate assays for detecting and measuring drug metabolites in biological matrices.

Basic Information

Product Name	Desethyl Sildenafil
CAS No.	139755-91-2
Molecular Formula	C20H26N6O4S
Molecular Weight	446.53 g/mol
Synonyms	N-Desethyl Sildenafil; UK-103,320; 5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one; Sildenafil Impurity D; Sildenafil N-Desethyl; Sildenafil Metabolite; UK 103320; Desethyl Sildenafil Base
EINECS	Contact for details

Quality Control

Our Desethyl Sildenafil is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis to ensure it meets the stringent requirements for pharmaceutical reference standards and intermediates. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term stability, storage at 2-8°C is recommended. Handle and store in accordance with good laboratory practices.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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