Sildenafil EP Impurity D NEW

Sildenafil EP Impurity D

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com.

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• Product Information

• Product Number: S005004

• English Name: Sildenafil EP Impurity D

• English Alias: 4-ethoxy-3-(1-methyl-7-oxo-3-propyl-6,7-dihydro-1H-pyrazolo[4,3-d]pyrimidin-5-yl)benzenesulfonic acid

• CAS Number: 1357931-55-5

• Molecular Formula: C₁₇H₂₀N₄O₅S

• Molecular Weight: 392.43

• Advantages

• As a European Pharmacopoeia (EP) impurity of Sildenafil, this compound has the following advantages:
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• Well-defined and distinct structure: Contains pyrazolo[4,3-d]pyrimidinone core, ethoxy group, and benzenesulfonic acid moiety, differing from sildenafil by a sulfonic acid (-SO₃H) instead of piperazine on the benzene ring. Significant polarity difference enables accurate identification via HPLC and LC-MS, providing a specific marker for impurity detection;

• High stability and traceability: Strong ionization of sulfonic acid ensures stability in aqueous solutions. As a by-product of benzene ring substitution in sildenafil synthesis, it directly reflects competition between sulfonic acid and piperazine substitution, improving process tracing accuracy;

• High detection sensitivity: Unique retention behavior of sulfonic acid in reversed-phase chromatography, combined with UV absorption of pyrazolopyrimidine (230-250nm), enables trace analysis via HPLC-UV or LC-MS, compatible with sulfonated heterocyclic compound detection systems.

• Applications

• Pharmaceutical quality control: Used as an EP reference standard to quantify Sildenafil EP Impurity D in APIs and formulations, ensuring residual sulfonic acid impurities meet pharmacopoeial standards;

• Synthesis optimization: Optimizing benzene ring substitution conditions (e.g., reagent selection, pH) by monitoring impurity levels to suppress sulfonation and enhance piperazine substitution selectivity;

• Impurity profile compliance: Validating sildenafil’s impurity profile against EP requirements to support regulatory submissions in quality research.

• Background Description

• Sildenafil, a PDE5 inhibitor for erectile dysfunction and pulmonary hypertension, features a pyrazolo[4,3-d]pyrimidinone core with benzene ring substituents. During synthesis, nucleophilic substitution may introduce ethoxy and sulfonic acid groups (instead of target piperazine), forming Sildenafil EP Impurity D. Listed as a controlled impurity in the European Pharmacopoeia, its control is critical for sildenafil quality assurance due to potential impacts on drug purity.

• Research Status

• Current research focuses on:
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• Analytical method advancement: Developing UPLC-DAD assays with optimized mobile phase pH for baseline separation of impurity and sildenafil, achieving detection limits as low as 0.05 ppm;

• Synthetic pathway refinement: Designing selective substitution strategies to minimize sulfonic acid impurity formation via solvent polarity regulation;

• Stability studies: Evaluating impurity degradation under varying pH and temperature to guide sildenafil formulation storage conditions;

• Pharmacopoeial method validation: Cross-verifying impurity quantification across platforms to ensure compliance with EP standards

This product is intended for laboratory use only!

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com