Description

Sildenafil Impurity 14 is a high-purity 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 impurity profiling studies. The reliable identification and quantification of this impurity are essential for maintaining drug efficacy and meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of sildenafil drug substances and finished products.
• Impurity Profiling and Control: Essential for identifying, monitoring, and controlling the levels of this specific impurity during the manufacturing process to ensure final product purity.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for sildenafil-related compounds.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of degradation products in sildenafil formulations.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data for impurity identification and qualification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) Testing: Used in routine QC laboratories to calibrate equipment and verify the accuracy of impurity assays in active pharmaceutical ingredients (APIs) and finished dosage forms.

Basic Information

Product Name	Sildenafil Impurity 14
CAS No.	2146091-79-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Desethyl Sildenafil N-Oxide; Sildenafil N-Oxide Desethyl Impurity; Sildenafil Related Compound 14; Sildenafil EP Impurity O; Sildenafil USP Related Compound; 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 1-Oxide
EINECS	Contact for details

Quality Control

Our Sildenafil Impurity 14 is manufactured under strict quality control protocols to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch is thoroughly characterized and tested using advanced analytical techniques, including HPLC, LC-MS, and NMR, to confirm identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality system is designed to support compliance with ICH, USP, and EP guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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