Description

Sildenafil Impurity 25 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing sildenafil citrate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The precise characterization of this impurity is essential for maintaining the stringent purity standards mandated in active pharmaceutical ingredient (API) production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in sildenafil API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity profiles in sildenafil-based products.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthesis pathways, helping to minimize the formation of this specific impurity.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing to ensure product specifications are met.

Basic Information

Product Name	Sildenafil Impurity 25
CAS No.	2021224-02-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sildenafil Related Compound 25; Sildenafil EP Impurity 25; Sildenafil USP Impurity 25; Sildenafil Process Impurity; 1-[[3-(6,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine (IUPAC-based); UK-92,480 Impurity; Revatio Impurity; Viagra Impurity
EINECS	Contact for details

Quality Control

Every batch of Sildenafil Impurity 25 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure it meets the high-purity standards required for pharmaceutical reference materials, with specifications typically aligned with pharmacopeial guidelines (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and impurity profiles as determined by advanced chromatographic and spectroscopic methods.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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