Description

Desethyl Carbodenafil is a high-purity pharmaceutical intermediate and reference standard of significant importance in analytical and research chemistry. Its primary value lies in its role as a key metabolite and impurity standard for the analysis of related pharmaceutical compounds, ensuring product safety and regulatory compliance. This compound is essential for quality control laboratories, research institutions, and pharmaceutical manufacturers engaged in method development, impurity profiling, and forensic analysis.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of active pharmaceutical ingredients (APIs) and their related substances.
• Impurity Profiling: Critical for identifying and quantifying process-related impurities and degradation products in pharmaceutical formulations to meet ICH Q3A/B guidelines.
• Metabolite Studies: Serves as a standard in pharmacokinetic and metabolic pathway research for related pharmacologically active compounds.
• Forensic Analysis: Employed in regulatory and forensic laboratories for the detection and confirmation of specific compounds in various samples.
• Method Development & Validation: Essential for developing, calibrating, and validating analytical methods such as HPLC, LC-MS, and GC-MS.
• Quality Assurance/Quality Control (QA/QC): Integral to in-house quality control protocols to ensure batch-to-batch consistency and purity of final drug products.

Basic Information

Product Name	Desethyl Carbodenafil
CAS No.	1027192-92-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carbodenafil Impurity; Desethylcarbodenafil; N-Desethyl Carbodenafil; 2-[[2-Ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]methyl]-5-methyl-7-propyl-imidazo[5,1-f][1,2,4]triazin-4-one; Aildenafil metabolite; Related substance of Carbodenafil
EINECS	Contact for details

Quality Control

Our Desethyl Carbodenafil is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assays and identity confirmation, to ensure it meets the high standards required for reference materials and pharmaceutical intermediates. A detailed Certificate of Analysis (COA) containing batch-specific results for identity, purity, and related substances is provided with every shipment to support your regulatory and quality documentation.

Storage

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

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 single unknown 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.