Description

Sildenafil Citrate is the active pharmaceutical ingredient (API) that revolutionized the treatment of erectile dysfunction and pulmonary arterial hypertension. Its primary value lies in its potent and selective inhibition of phosphodiesterase type 5 (PDE5), which facilitates vasodilation. This high-purity compound is essential for pharmaceutical manufacturers developing generic and branded formulations, as well as for research institutions conducting pharmacological studies. Consistent quality and reliable supply are paramount for ensuring the efficacy and safety of the final medicinal products.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of tablets and other dosage forms for the treatment of erectile dysfunction (ED).
• Pulmonary Hypertension Treatment: Key component in medications prescribed for pulmonary arterial hypertension (PAH) to improve exercise capacity.
• Generic Drug Production: Sourcing for companies producing bioequivalent generic versions of branded PDE5 inhibitor drugs.
• Research & Development: Used in preclinical and clinical research to study PDE5 inhibition, cardiovascular effects, and new therapeutic applications.
• Reference Standard: Serves as a high-purity analytical standard for quality control laboratories to test finished products and raw materials.
• Veterinary Medicine: Investigated for use in treating certain cardiovascular conditions in animals.

Basic Information

Product Name	Sildenafil Citrate
CAS No.	171599-83-0
Molecular Formula	C28H38N6O11S
Molecular Weight	666.7 g/mol
Synonyms	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 citrate; Viagra (trade name, for the finished drug); Revatio (trade name, for the PAH indication); Sildenafil; 5-[2-Ethoxy-5-(4-methylpiperazin-1-ylsulfonyl)phenyl]-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one citrate salt
EINECS	Contact for details

Quality Control

Our Sildenafil Citrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with pharmacopeial standards such as USP and EP. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting critical parameters including assay, related substances, residual solvents, and microbiological quality to guarantee supply reliability and regulatory compliance for our global B2B partners.

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 material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%
Microbiological Enumeration	Complies with EP/USP

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