Description

Drofenine Hydrochloride is a pharmaceutical-grade active pharmaceutical ingredient (API) and a quaternary ammonium compound with anticholinergic properties. This compound is critical for the development and production of specialized therapeutic agents targeting smooth muscle spasms. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the formulation of antispasmodic medications and advanced pharmacological studies.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of antispasmodic and anticholinergic medications.
• Gastrointestinal Therapeutics: Used in drugs designed to treat conditions like irritable bowel syndrome (IBS) and other gastrointestinal motility disorders.
• Urological Spasmolytics: Key component in medications for relieving bladder and urinary tract spasms.
• Chemical Synthesis Intermediate: Serves as a crucial building block in the organic synthesis of more complex quaternary ammonium compounds.
• Pharmacological Research: A standard reference compound in studies investigating muscarinic receptor antagonists and their mechanisms of action.
• Veterinary Medicine: Employed in veterinary pharmaceuticals for managing visceral spasms in animals.

Basic Information

Product Name	Drofenine Hydrochloride
CAS No.	548-66-3
Molecular Formula	C₂₀H₂₄ClNO₂
Molecular Weight	345.86 g/mol
Synonyms	Drofenine HCl; 2-(Diethylamino)ethyl 2-cyclohexyl-2-phenylacetate hydrochloride; 2-Cyclohexyl-2-phenylacetic acid 2-(diethylamino)ethyl ester hydrochloride; Spasmolytin; Spasmophen; Trofentyl; NSC-526046; EINECS 208-965-7
EINECS	208-965-7

Quality Control

Our Drofenine Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with specifications for identity, purity, and impurity profiles. We support compliance with cGMP, ICH Q7 guidelines, and relevant pharmacopoeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to prevent moisture absorption, which can affect stability and potency.

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 ≤ 2.0% Any single impurity ≤ 0.5%

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