Description

Neltenexine is a synthetic chemical compound with significant pharmacological activity, primarily recognized for its mucolytic properties. This makes it a valuable active pharmaceutical ingredient (API) for developing formulations that effectively manage respiratory conditions by reducing mucus viscosity. It is essential for manufacturers in the pharmaceutical industry seeking reliable, high-purity intermediates for advanced respiratory therapeutics. The compound is supplied under stringent quality controls to ensure batch-to-batch consistency for critical R&D and production processes.

Application

• Pharmaceutical Intermediate: Serves as a key building block in the synthesis of advanced mucolytic and expectorant drug formulations.
• Active Pharmaceutical Ingredient (API): Used as the primary active component in prescription medications for treating chronic bronchitis, COPD, and other respiratory disorders characterized by excessive mucus.
• Research & Development: Employed in pharmacological studies and preclinical research to investigate new mechanisms of action for respiratory therapies.
• Reference Standard: Utilized as an analytical standard in quality control laboratories for method development, validation, and impurity profiling of related drug products.
• Veterinary Pharmaceuticals: Incorporated into veterinary medicinal products for managing respiratory conditions in animals.

Basic Information

Product Name	Neltenexine
CAS No.	99453-84-6
Molecular Formula	C14H21NO3
Molecular Weight	251.32 g/mol
Synonyms	Neltenexine; N-(2,2-Diphenylethyl)-N-methylglycine; Erdo® (common trade name); 2-[(2,2-Diphenylethyl)(methyl)amino]acetic acid; (2,2-Diphenylethyl)(methyl)aminoacetic acid; N-Methyl-N-(2,2-diphenylethyl)glycine; Mucolytic agent ERD 308
EINECS	Contact for details

Quality Control

Our Neltenexine is manufactured under a strict quality management system. Every batch is subjected to comprehensive analytical testing, including identification, purity assay, and impurity profiling via HPLC, to ensure it meets exacting pharmaceutical-grade specifications. We provide full traceability and support our customers with detailed Certificates of Analysis (COA) for each shipment, confirming compliance with relevant pharmacopeial standards (such as USP/EP) and internal specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to protect contents from moisture. Keep away from incompatible materials.

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)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Heavy Metals	≤ 20 ppm

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