Description

Sildenafil Dimer Impurity CAS NO 1346602-67-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critically important 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.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of the dimer impurity in sildenafil API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and release testing of sildenafil-based drug products to meet ICH, USP, and EP guidelines.
• Stability Studies: Employed to track the formation of degradation products in sildenafil formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the impurity's behavior and potential impact.

Basic Information

Product Name	Sildenafil Dimer Impurity
CAS No.	1346602-67-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sildenafil Dimer; Sildenafil Related Compound Dimer; 1-[[3-(6,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine Dimer; Sildenafil Impurity Dimer; PDE5 Inhibitor Dimer Impurity; Viagra Dimer Impurity
EINECS	Contact for details

Quality Control

Our Sildenafil Dimer Impurity is manufactured under strict quality systems to ensure the highest standards of purity and consistency. Each batch undergoes comprehensive analytical testing, including HPLC, LC-MS, and NMR, to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results and confirming compliance with relevant standards. Our quality commitment aligns with cGMP principles to support your regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.5%
Residual Solvents (GC)	Meets 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.