Description

Milnacipran Related Compound A (2-(Aminomethyl)-1-Phenylcyclopropane-1-Carboxylic Acid Hydrochloride) is a high-purity chemical reference standard essential for pharmaceutical research and quality control. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Milnacipran HCl, a medication used to treat fibromyalgia and major depressive disorder. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method development, validation, and impurity profiling. The product is supplied as a 25 mg unit, ideal for precise laboratory use.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specified impurities in Milnacipran Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing within GMP environments to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP, ICH).
• Stability Studies: Used to track the formation of degradation products in Milnacipran formulations under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Development: Facilitates studies on the metabolism, pharmacokinetics, and toxicological profile of Milnacipran and its related substances.

Basic Information

Item	Details
Product Name	Milnacipran Related Compound A (25 Mg) (2-(Aminomethyl)-1-Phenylcyclopropane-1-Carboxylic Acid Hydrochloride)
CAS No.	871100-19-5
Molecular Formula	C12H15NO2 • HCl
Molecular Weight	241.71 g/mol (Free base: 205.25 g/mol)
Synonyms	2-(Aminomethyl)-1-phenylcyclopropanecarboxylic acid hydrochloride; 1-Phenyl-2-(aminomethyl)cyclopropanecarboxylic acid hydrochloride; (1R*,2S*)-rel-2-(Aminomethyl)-1-phenylcyclopropanecarboxylic acid hydrochloride; Milnacipran Impurity A; Milnacipran Related Substance A; F 2207 Related Compound A; F 2695 Impurity; Ixel Impurity A
EINECS	Contact for details

Quality Control

Every batch of Milnacipran Related Compound A is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, purity assessment, and impurity profiling via advanced analytical techniques. Certificates of Analysis (COA) are available upon request, providing full traceability and detailed results for parameters such as assay, related substances, residual solvents, and water content, aligning with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Water Content (KF)	≤ 1.0%
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.