Description

(1S-Cis)-Milnacipran Hydrochloride is the active pharmaceutical ingredient (API) corresponding to the pure cis-(1S,2R) enantiomer of milnacipran. This high-purity chiral compound is critical for ensuring the efficacy and safety of the final pharmaceutical formulation. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of enantiomerically pure antidepressant and analgesic medications.

Application

• Active Pharmaceutical Ingredient (API): Primary use in the formulation of finished dosage forms, such as tablets and capsules, for the treatment of major depressive disorder (MDD) and fibromyalgia.
• Reference Standard: Serves as a certified reference material (CRM) for analytical method development, validation, and quality control testing in pharmaceutical laboratories.
• Pharmacological Research: Used in preclinical and clinical studies to investigate the specific pharmacological profile, metabolism, and safety of the (1S,2R)-enantiomer.
• Process Development: Employed in the development and optimization of asymmetric synthesis and chiral separation processes within R&D and pilot-scale production.
• Regulatory Submissions: Essential component in the chemistry, manufacturing, and controls (CMC) documentation for regulatory filings with agencies like the FDA and EMA.

Basic Information

Product Name	(1S-Cis)-Milnacipran Hydrochloride
CAS No.	175131-60-9
Molecular Formula	C15H23ClN2O
Molecular Weight	282.81 g/mol
Synonyms	(1S,2R)-Milnacipran Hydrochloride; cis-(1S,2R)-Milnacipran HCl; (1S,2R)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide Hydrochloride; F 2696; Midalcipran; Ixel; Savella; Dalcipran; Toledomin; TN-912
EINECS	Contact for details

Quality Control

Our (1S-Cis)-Milnacipran Hydrochloride is manufactured under strict quality management systems. Each batch is tested to meet stringent specifications for identity, purity, and enantiomeric excess, ensuring compliance with ICH guidelines and current Good Manufacturing Practice (cGMP) standards for active pharmaceutical ingredients. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Enantiomeric Purity (Chiral HPLC)	≥ 99.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 1.0%
Microbial Enumeration	Meets Ph. Eur. 2.6.12 / USP <61> requirements

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