Description

Sildenafil Ep Impurity D CAS NO 1357931-55-5 is a high-purity reference standard and pharmaceutical impurity used in the quality control of active pharmaceutical ingredients (APIs). This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products containing sildenafil citrate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification in Sildenafil API and finished dosage forms.
• Analytical Reference Standard for method development and validation in HPLC, UPLC, and LC-MS.
• Quality Control (QC) and Quality Assurance (QA) testing to monitor and control impurity levels per ICH guidelines.
• Regulatory Compliance and Submission, supporting drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies to track the formation of degradation products under various stress conditions.
• Research and Development (R&D) for studying the metabolism and degradation pathways of sildenafil.

Basic Information

Product Name	Sildenafil Ep Impurity D
CAS No.	1357931-55-5
Molecular Formula	C22H30N6O4S
Molecular Weight	474.58 g/mol
Synonyms	1-[[3-(6,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine; Sildenafil Impurity 4; Sildenafil Related Compound D; Sildenafil EP Impurity D; Sildenafil USP Impurity D; Sildenafil Degradant D; 5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-propyl-6,7-dihydro-1H-pyrazolo[4,3-d]pyrimidin-7-one
EINECS	Contact for details

Quality Control

Our Sildenafil Ep Impurity D is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and qualified using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with relevant pharmacopeial standards (EP, USP).

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 accordingly 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
Water Content (KF)	≤ 1.0%
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)

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