Ambroxol Hydrochloride (CAS: 18683-91-5)

Model:AMB-API99 | CAS: 18683-91-5 | Purity: 99.0% - 101.0% (USP/EP/BP Grade API)

Superpharmagroup is a leading Ambroxol Hydrochloride manufacture and trusted supplier offering high purity CAS 18683-91-5 API powder. Meeting USP, EP, and BP pharmacopeial standards, our Ambroxol HCl features high chemical stability, ultra-low impurity levels, and reliable bulk supply.

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Product Description

Physical & Chemical Properties

Property Item	Specification Standard
Product Name	Ambroxol Hydrochloride / Ambroxol HCl
CAS Number	18683-91-5
Chemical Formula	C13H19Br2ClN2O
Molecular Weight	414.57 g/mol
Appearance	White or slightly yellowish crystalline powder
Assay (HPLC/Titration)	99.0% – 101.0% (Dried basis)
Melting Point	235.0 °C to 240.0 °C (Decomposition)
pH (1% Water Solution)	4.5 – 6.0
Loss on Drying	≤ 0.5%
Related Substances	Individual Impurities ≤ 0.1%, Total Impurities ≤ 0.3%
Grade Standard	EP / USP / BP / CP / Pharma Grade API

Technical & Quality Advantages of Ambroxol Hydrochloride (CAS: 18683-91-5)

High Mucolytic Efficacy & Secretolytic Activity: Promotes mucus clearance by stimulating surfactant secretion and breaking down acid mucopolysaccharide fibers, providing targeted performance for respiratory formulation stability.
Strict Impurity Profile & Residual Solvent Limits: Engineered with advanced crystallization processing to keep related substances (such as Impurity A and Impurity B) well below strict European Pharmacopoeia (EP) and USP monograph limits.
Exceptional Water Solubility & Formulation Compatibility: Demonstrates fast dissolution rates and high stability in aqueous media, rendering it highly ideal for liquid oral syrups, drop solutions, and dispersible tablets without risk of precipitate formation.
Multi-Pharmacopeial Monograph Compliance: Fully compliant with EP, USP, BP, and CP standard requirements, validated through robust batch-to-batch analytical control, heavy metal limits, and dark-shelf stability testing.

Key Applications

Expectorant & Mucolytic Formulations: Widely used as the primary active pharmaceutical ingredient (API) in cough syrups, oral drops, effervescent tablets, and inhalation solutions for acute and chronic respiratory disorders.
Expectorant & Mucolytic Formulations: Widely used as the primary active pharmaceutical ingredient (API) in cough syrups, oral drops, effervescent tablets, and inhalation solutions for acute and chronic respiratory disorders.