Description

Sildenafil Aldehyde Impurity is a key chemical reference standard used in the analytical profiling and quality control of active pharmaceutical ingredients (APIs). This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical products by serving as a benchmark for identifying and quantifying related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the research, development, and quality assurance of sildenafil-based formulations.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of aldehyde-related impurities in Sildenafil Citrate API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and GC analytical methods in compliance with ICH guidelines.
• Quality Control (QC) and Quality Assurance (QA): Essential for routine batch release testing in pharmaceutical manufacturing to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance and Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of pharmaceutical stability testing protocols.
• Research and Development: Used in synthetic chemistry R&D to study reaction pathways, optimize synthesis processes, and minimize the formation of this specific impurity.

Basic Information

Product Name	Sildenafil Aldehyde Impurity
CAS No.	845302-49-0
Molecular Formula	C22H30N6O4S
Molecular Weight	474.58 g/mol
Synonyms	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 aldehyde impurity; Sildenafil Related Compound Aldehyde; Sildenafil EP Impurity F; Sildenafil USP Aldehyde Impurity; Sildenafil Process Impurity; Aldehyde derivative of Sildenafil
EINECS	Contact for details

Quality Control

Every batch of Sildenafil Aldehyde Impurity CAS NO 845302-49-0 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material 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)	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.