Description

Ambroxol Hydrochloride is a potent mucolytic agent and active pharmaceutical ingredient (API) primarily used in the treatment of respiratory conditions. Its core value lies in its ability to effectively reduce the viscosity of bronchial secretions, facilitating expectoration and improving airway clearance. This makes it a critical component for pharmaceutical manufacturers developing cough syrups, lozenges, tablets, and other formulations aimed at managing acute and chronic bronchitis, asthma, and similar disorders. Global B2B buyers in the pharmaceutical and nutraceutical sectors rely on a consistent, high-purity supply of Ambroxol Hydrochloride CAS NO 23828-92-4 to ensure the efficacy and safety of their final medicinal products.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription and over-the-counter (OTC) cough, cold, and expectorant medications.
• Tablet Formulations: Used in the production of solid oral dosage forms, including immediate-release and sustained-release tablets.
• Syrup and Oral Solution Production: A key component in liquid formulations such as cough syrups, pediatric drops, and oral solutions.
• Lozenges and Pastilles: Incorporated into medicated confectionery for localized throat relief and mucolytic action.
• Respiratory Combination Drugs: Combined with other APIs like antibiotics, bronchodilators, or antihistamines in complex therapeutic formulations.
• Veterinary Pharmaceuticals: Applied in veterinary medicine for the treatment of respiratory conditions in animals.
• Research and Development: Serves as a reference standard and starting material in pharmacological research and new drug development.

Basic Information

Product Name	Ambroxol Hydrochloride
CAS No.	23828-92-4
Molecular Formula	C13H18Br2N2O • HCl
Molecular Weight	414.56 g/mol
Synonyms	trans-4-[(2-Amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride; Ambroxol HCl; NA-872; Sputolysin; Mucosolvan; Mucoclear; Bromhexine metabolite VIII; 2-Amino-3,5-dibromo-N-(trans-4-hydroxycyclohexyl)benzylamine hydrochloride
EINECS	Contact for details

Quality Control

Our Ambroxol Hydrochloride is manufactured and tested under a strict quality management system. It is produced to meet high-purity standards suitable for pharmaceutical applications, with potential alignment to pharmacopeial monographs such as USP, EP, or BP upon request. Every batch undergoes rigorous analytical testing, including identification, assay, impurity profiling, and residual solvent analysis. Certificates of Analysis (COA) documenting all critical quality attributes are provided to ensure full traceability and compliance with your regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture.

Specification

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

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