Description

Milnacipran Hydrochloride is a high-purity active pharmaceutical ingredient (API) primarily used as a serotonin-norepinephrine reuptake inhibitor (SNRI). This compound is critical for the formulation of antidepressant and fibromyalgia management medications, ensuring consistent therapeutic efficacy. It is essential for pharmaceutical manufacturers, research institutions, and developers of generic and novel drug formulations requiring a reliable, well-characterized API.

Application

• Pharmaceutical API: Primary use in the manufacture of antidepressant and analgesic medications.
• Generic Drug Development: Serves as the key active ingredient for bioequivalent generic versions of branded SNRI drugs.
• Clinical Research: Used in preclinical and clinical studies for investigating new therapeutic applications of SNRIs.
• Reference Standard: Acts as a high-purity standard for analytical testing and quality control in laboratories.
• Formulation R&D: Employed in the development of various dosage forms, including tablets and capsules.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for commercial-scale production.

Basic Information

Product Name	Milnacipran Hydrochloride
CAS No.	92623-85-3
Molecular Formula	C15H23ClN2O
Molecular Weight	282.81 g/mol
Synonyms	Milnacipran HCl; F 2207; Dalcipran; Ixel; (1R*,2S*)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride; (±)-Milnacipran hydrochloride; 1-Phenyl-1-diethylaminocarbonyl-2-aminomethylcyclopropane hydrochloride
EINECS	Contact for details

Quality Control

Our Milnacipran Hydrochloride is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets high-purity pharmacopeial standards. We provide comprehensive support for regulatory filings, and a detailed Certificate of Analysis (COA) is available for every batch, confirming compliance with specifications for identity, purity, and impurities.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
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)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Optical Rotation	Contact for details

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