Description

Ambroxol Hydrochloride CAS NO 15942-05-9 is a potent mucolytic agent and active pharmaceutical ingredient (API) primarily used as an expectorant. It works by increasing the production of pulmonary surfactant and thinning bronchial secretions, facilitating their clearance from the airways. This compound is essential for the formulation of pharmaceutical products targeting respiratory conditions such as chronic bronchitis, asthma, and other disorders associated with viscous mucus.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription and over-the-counter (OTC) cough syrups, tablets, and lozenges.
• Respiratory Therapeutics: Formulation of medications for acute and chronic bronchopulmonary diseases, including chronic obstructive pulmonary disease (COPD) and bronchiectasis.
• Pediatric Formulations: Development of age-appropriate dosage forms for treating respiratory congestion in children.
• Combination Drug Products: Used in fixed-dose combinations with antibiotics, antihistamines, or other bronchodilators for enhanced therapeutic effect.
• Veterinary Medicine: Incorporated into veterinary pharmaceuticals for treating respiratory ailments in animals.
• Research & Development: Serves as a reference standard and key intermediate in pharmacological research for new mucoactive agents.

Basic Information

Product Name	Ambroxol Hydrochloride
CAS No.	15942-05-9
Molecular Formula	C13H18Br2N2O • HCl
Molecular Weight	414.96 g/mol
Synonyms	Ambroxol HCl; trans-4-[(2-Amino-3,5-dibromobenzyl)amino]cyclohexanol Hydrochloride; NA-872; Sputolysin; Mucosolvan; Ambrohexal; Lasolvan; Ambrodil; Ventilat
EINECS	240-103-6

Quality Control

Our Ambroxol Hydrochloride is manufactured under strict quality management systems. It is tested to meet or exceed relevant pharmacopoeial standards, including USP and EP monographs. Every batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles to ensure regulatory compliance and batch-to-batch consistency for pharmaceutical use.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and should be kept in a dry environment.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water (KF Titration)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Specific Optical Rotation	Contact for details

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