Description

Sildenafil Hydrochloride CAS NO 252920-86-8 is the active pharmaceutical ingredient (API) of the well-known erectile dysfunction medication. This high-purity compound is critical for ensuring the efficacy, safety, and batch-to-batch consistency of finished pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of generic and branded medications.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of tablets and other dosage forms for the treatment of erectile dysfunction.
• Generic Drug Production: Sourcing for companies developing and manufacturing bioequivalent generic versions of branded medications.
• Clinical Research: Use as a reference standard or active component in clinical trials and bioavailability studies.
• Formulation Development: Employed in R&D labs for developing new drug delivery systems, such as orally disintegrating tablets or sustained-release formulations.
• Analytical Testing: Serves as a high-purity standard for quality control laboratories performing HPLC, UV, and other spectroscopic assays.
• Contract Manufacturing: Supply to CDMOs (Contract Development and Manufacturing Organizations) producing finished drug products for various markets.

Basic Information

Product Name	Sildenafil Hydrochloride
CAS No.	252920-86-8
Molecular Formula	C22H31ClN6O4S
Molecular Weight	523.04 g/mol
Synonyms	UK-92,480; Sildenafil Citrate Hydrochloride; 1-[[3-(6,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine Hydrochloride; Viagra API; Sildenafil HCl; 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 Hydrochloride
EINECS	Contact for details

Quality Control

Our Sildenafil Hydrochloride is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee traceability and compliance.

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) and must be kept in a dry environment to prevent degradation. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.5% - 101.5% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Water Content (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Enumeration	Complies with Ph. Eur. / USP guidelines

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