Description

Milnacipran Impurity CAS NO 810696-16-3 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the antidepressant drug Milnacipran by enabling accurate identification and quantification of related substances. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Milnacipran Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure Milnacipran batches comply with pharmacopeial (USP, EP) and ICH Q3A/B guidelines on impurities.
• Stability Studies: Employed as a marker to track impurity formation during forced degradation and long-term stability studies of Milnacipran.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Research & Development: Supports synthetic route development and process optimization by helping to identify and control process-related impurities.

Basic Information

Item	Detail
Product Name	Milnacipran Impurity
CAS No.	810696-16-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Milnacipran Related Compound; Milnacipran Process Impurity; 1-Phenyl-1-diethylaminocarbonyl-2-aminomethylcyclopropane hydrochloride (possible structural analog); Milnacipran EP Impurity; Milnacipran USP Impurity; Savella Impurity; Ixel Impurity
EINECS	Contact for details

Quality Control

Our Milnacipran Impurity is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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 solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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