Description

Udenafil CAS NO 268203-93-6 is a potent and selective phosphodiesterase type 5 (PDE5) inhibitor. This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacturing of effective treatments for erectile dysfunction and pulmonary arterial hypertension. It is primarily utilized by pharmaceutical companies, research institutions, and contract manufacturing organizations (CMOs) engaged in the production of innovative and generic medications. Our supply ensures consistent quality and reliable availability for critical global healthcare applications.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of tablets and capsules for the treatment of erectile dysfunction (ED).
• Pulmonary Arterial Hypertension (PAH) Treatment: Used in the development of medications to improve exercise capacity in patients with PAH.
• Research & Development: Serves as a key reference standard and building block in preclinical and clinical studies for new PDE5 inhibitor-based therapies.
• Generic Drug Manufacturing: Essential for companies producing bioequivalent versions of branded PDE5 inhibitor medications.
• Contract Pharmaceutical Manufacturing: Supplied to CMOs for the production of finished dosage forms under strict quality agreements.
• Chemical Synthesis Intermediate: Used in the synthesis of more complex pharmaceutical molecules or for derivative studies.

Basic Information

Product Name	Udenafil
CAS No.	268203-93-6
Molecular Formula	C₂₅H₃₄N₆O₄S
Molecular Weight	514.65 g/mol
Synonyms	Udenafil; Zydena; DA-8159; 1-[3-(6,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine; 5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one
EINECS	Contact for details

Quality Control

Our Udenafil 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 ICH Q7 guidelines for active pharmaceutical ingredients. 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 controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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