Description

Vardenafil Hydrochloride Trihydrate CAS NO 330808-88-3 is the active pharmaceutical ingredient (API) form of a potent and selective phosphodiesterase type 5 (PDE5) inhibitor. 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 treatments for erectile dysfunction and pulmonary arterial hypertension.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of prescription medications for erectile dysfunction.
• Generic Drug Production: Serves as the key component for formulating generic versions of branded PDE5 inhibitor drugs.
• Clinical Research: Used in preclinical and clinical studies to investigate pharmacological profiles and therapeutic efficacy.
• Dosage Form Development: Integral to R&D for creating various oral dosage forms such as tablets, orally disintegrating tablets (ODTs), and films.
• Reference Standard: Employed as a high-purity analytical standard in quality control laboratories for HPLC, dissolution testing, and assay validation.
• Pulmonary Arterial Hypertension (PAH) Research: Investigated for potential applications in treating PAH due to its vasodilatory effects.

Basic Information

Product Name	Vardenafil Hydrochloride Trihydrate
CAS No.	330808-88-3
Molecular Formula	C23H33ClN6O4S • HCl • 3H2O
Molecular Weight	615.98 g/mol (Trihydrate form)
Synonyms	Vardenafil HCl Trihydrate; Levitra API; Nuviva; 2-[2-Ethoxy-5-[(4-ethylpiperazin-1-yl)sulfonyl]phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4(3H)-one hydrochloride trihydrate; BA-38,024; (3S,5aS,6R,8aS,9R,10S,12aR)-3-(Ethoxycarbonyloxy)-6,10-dihydroxy-9-methyl-1-oxo-5a,6,8a,9-tetrahydro-1H,8H-2λ⁶-thia-3,5a,8,8a-tetraaza-cyclopenta[a]inden-4-yl 4-ethylpiperazine-1-sulfonate hydrochloride trihydrate
EINECS	Contact for details

Quality Control

Our Vardenafil Hydrochloride Trihydrate 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 guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment.

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 compound is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity to prevent degradation and ensure stability.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	7.0% - 9.0%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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