Description

Sildenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), a key enzyme in the regulation of blood flow. This compound is the active pharmaceutical ingredient (API) critical for the formulation of medications used to treat erectile dysfunction and pulmonary arterial hypertension. It is essential for pharmaceutical manufacturers, research institutions, and developers of generic drugs who require a reliable, high-purity active ingredient for therapeutic applications.

Application

• Pharmaceutical API: Primary active ingredient in medications for erectile dysfunction (e.g., Viagra®).
• Pulmonary Hypertension Treatment: Key component in drugs for pulmonary arterial hypertension (PAH).
• Generic Drug Development: Sourcing for the production of bioequivalent generic formulations.
• Pharmaceutical Research: Reference standard and building block for pharmacological and clinical studies.
• Formulation Development: Used in R&D for developing new dosage forms (tablets, orally disintegrating films).
• Contract Manufacturing: Supply to CDMOs (Contract Development and Manufacturing Organizations) for finished dosage production.

Basic Information

Product Name	Sildenafil
CAS No.	139755-83-2
Molecular Formula	C22H30N6O4S
Molecular Weight	474.58 g/mol
Synonyms	Sildenafil Citrate (Salt Form); UK-92,480; 1-[[3-(6,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine; Viagra® (Brand Name); Revatio® (Brand Name); PDE5 Inhibitor; Sildenafil Base
EINECS	Contact for details

Quality Control

Our Sildenafil is manufactured under strict quality management systems. It undergoes comprehensive analytical testing to ensure it meets high-purity pharmacopeial standards, including identification, assay, and impurity profile analysis. A Certificate of Analysis (COA) is provided with each batch, detailing compliance with specifications. We support compliance with cGMP, ICH Q7 guidelines, and relevant regulatory frameworks (FDA, EMA) for active pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be kept in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	NMT 1.0%
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	NMT 20 ppm
Sulfated Ash	NMT 0.1%

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