Description

(1R-Cis)-Milnacipran Hydrochloride is the active pharmaceutical ingredient (API) of the chiral antidepressant drug Milnacipran. This high-purity enantiomer is critical for ensuring the specific pharmacological activity and consistent therapeutic efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers and advanced research institutions for the development and production of serotonin-norepinephrine reuptake inhibitor (SNRI) medications.

Application

• Active Pharmaceutical Ingredient (API) for the manufacture of Milnacipran-based antidepressant medications.
• Reference Standard for analytical method development and validation in quality control laboratories.
• Pharmacological Research for studying the mechanism of action of SNRIs and related neurological pathways.
• Formulation Development for creating new dosage forms such as tablets, capsules, or controlled-release systems.
• Process Chemistry & Scale-Up for optimizing synthetic routes and manufacturing processes.
• Regulatory Submissions as a characterized component in Drug Master Files (DMFs) and New Drug Applications (NDAs).

Basic Information

Product Name	(1R-Cis)-Milnacipran Hydrochloride
CAS No.	175131-61-0
Molecular Formula	C15H23ClN2O
Molecular Weight	282.81 g/mol
Synonyms	(1R,2S)-Milnacipran Hydrochloride; F 2695; F2695; (1R,2S)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide Hydrochloride; (1R,2S)-rel-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide Hydrochloride; (1R,2S)-2-[(Aminomethyl)]-N,N-diethyl-1-phenylcyclopropanecarboxamide Hydrochloride; Dalcipran (enantiomer); Ixel (enantiomer); Savella (enantiomer)
EINECS	Contact for details

Quality Control

Our (1R-Cis)-Milnacipran Hydrochloride is manufactured under strict quality management systems. Each batch is tested to meet stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, enantiomeric purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

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)
Enantiomeric Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C

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