Description

Milnacipran Impurity 13 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Milnacipran HCl. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of Milnacipran-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in Milnacipran HCl active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used in developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine QC testing to ensure API and drug product batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to monitor the formation of degradation products in Milnacipran formulations under various stress conditions (e.g., heat, light, humidity) over time.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA and EMA.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation pathways during the manufacturing process of Milnacipran.

Basic Information

Product Name	Milnacipran Impurity 13
CAS No.	710339-49-4
Molecular Formula	C17H25NO2
Molecular Weight	275.39 g/mol
Synonyms	(1R,2S)-2-(Aminomethyl)-1-phenylcyclopropanecarboxylic acid; (1R,2S)-rel-2-(Aminomethyl)-1-phenylcyclopropanecarboxylic acid; Milnacipran Related Compound; Milnacipran Impurity F; (1R,2S)-2-(Aminomethyl)-1-phenylcyclopropane-1-carboxylic acid; trans-2-(Aminomethyl)-1-phenylcyclopropanecarboxylic acid; FCCP Impurity; Contact for details for additional synonyms.
EINECS	Contact for details

Quality Control

Our Milnacipran Impurity 13 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Quality is assured through comprehensive testing via HPLC, NMR, and Mass Spectrometry. A detailed Certificate of Analysis (COA) is provided with each batch, confirming identity, purity, and compliance with relevant standards. Our quality system supports compliance with cGMP and ICH guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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