Description

Naftopidil Dihydrochloride is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) primarily used in the development and manufacturing of therapeutic agents. This compound matters for its critical role as an α-1 adrenergic receptor antagonist, specifically targeting the α1D subtype. Pharmaceutical manufacturers and research institutions need it for producing medications aimed at treating conditions such as benign prostatic hyperplasia (BPH) and for ongoing pharmacological research into cardiovascular and urological disorders. Its availability in high-purity grades is essential for ensuring the safety and efficacy of final drug formulations.

Application

• Pharmaceutical API Manufacturing: Primary use as the active ingredient in finished dosage forms for the treatment of urinary dysfunction.
• Benign Prostatic Hyperplasia (BPH) Treatment: Key component in medications designed to relax smooth muscle in the prostate and bladder neck.
• Pharmacological Research: Used in preclinical and clinical studies to investigate α-1 adrenoceptor mechanisms and drug efficacy.
• Reference Standard: Serves as a high-purity analytical standard for quality control testing in pharmaceutical laboratories.
• Formulation Development: Employed in R&D for developing new drug delivery systems, such as tablets or capsules.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for commercial-scale drug production.

Basic Information

Product Name	Naftopidil Dihydrochloride
CAS No.	57149-08-3
Molecular Formula	C₂₄H₂₈N₂O₃·2HCl
Molecular Weight	465.41 g/mol
Synonyms	Naftopidil HCl; Naftopidil Dihydrochloride; (±)-Naftopidil Dihydrochloride; 1-[4-(2-Methoxyphenyl)piperazin-1-yl]-3-(1-naphthyloxy)propan-2-ol dihydrochloride; AV-25800; AV25800; Flivas; Naftopidil Hydrochloride (common misnomer); NAF
EINECS	Contact for details

Quality Control

Our Naftopidil Dihydrochloride is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing purity, impurity profiles, and results from identity and assay tests. Our quality commitment aligns with ICH guidelines and current Good Manufacturing Practice (cGMP) principles where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after each use to prevent degradation from atmospheric moisture. Keep away from incompatible materials.

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)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%

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