Description

De(Methypiperazinyl) Sildenafil Dimer Impurity CAS NO 1346603-48-2 is a structurally defined process-related impurity arising during the synthesis of sildenafil citrate, specifically formed via dimerization involving methylation and piperazinyl modification. This impurity is critical for pharmaceutical quality control, enabling accurate identification, quantification, and elimination to ensure final drug substance compliance with ICH Q3A(R2) guidelines. It is essential for regulatory filing batches, stability studies, and method validation by API manufacturers, contract research organizations (CROs), and quality assurance laboratories worldwide.

Application

• Reference standard for HPLC and UPLC method development and validation in sildenafil API manufacturing
• Qualitative and quantitative calibration material for impurity profiling per ICH Q5 and Q3A(R2) requirements
• Stability-indicating assay component to monitor dimer formation under accelerated storage conditions
• Spiking agent for forced degradation studies (e.g., oxidative, thermal, and photolytic stress testing)
• Internal standard candidate in LC-MS/MS assays for trace-level impurity detection
• Raw material for synthetic route optimization to suppress dimer formation during sildenafil synthesis
• Training reference for QC laboratory personnel in impurity identification and reporting
• Regulatory submission support for FDA, EMA, PMDA, and WHO prequalification dossiers

Basic Information

Product Name	De(Methypiperazinyl) Sildenafil Dimer Impurity
CAS No.	1346603-48-2
Molecular Formula	C₅₈H₇₄N₁₆O₈
Molecular Weight	1147.32 g/mol
Synonyms	De(methypiperazinyl) sildenafil dimer; Sildenafil dimer impurity B; N,N'-[1,4-Phenylenebis(methylene)]bis[N-(2-methoxyethyl)-N-(4-methylpiperazin-1-yl)sulfonamide] derivative; Sildenafil-related compound DB; 1346603-48-2; De-Methylpiperazinyl Sildenafil Dimer; Sildenafil dimer (methypiperazinyl-deleted variant); N⁴,N⁴'-Bis(2-methoxyethyl)-N¹,N¹'-bis[4-methylpiperazin-1-yl]sulfonyl-4,4'-diaminostilbene impurity
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. Each batch is tested per ICH Q5 and Q2(R2) guidelines using validated HPLC-UV and LC-MS methods. Purity is confirmed by HPLC (≥98.5% area), identity verified by LC-MS and ¹H-NMR, and residual solvents assessed per ICH Q3C. All materials are manufactured under controlled conditions compliant with cGMP principles and fully documented for regulatory traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8 °C under inert atmosphere (nitrogen or argon) to prevent oxidation and degradation. Keep away from moisture and direct sunlight. Handle in a cool, dry, well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (LC-MS)	m/z 1147.3 [M+H]⁺; retention time matches reference
Assay (HPLC)	≥98.5% (area %)
Related Substances	Single impurity ≤0.3%; Total impurities ≤1.5%
Residual Solvents	Meets ICH Q3C limits (e.g., acetonitrile ≤410 ppm, methanol ≤3000 ppm)
Water (KF)	≤0.5% w/w
Heavy Metals	≤10 ppm

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