Swapnroop Drugs & Pharmaceuticals offers Bromhexine Hydrochloride API for pharmaceutical manufacturing, formulation development and respiratory medicine applications.
Bromhexine Hydrochloride is the hydrochloride salt of bromhexine and is a mucolytic pharmaceutical active ingredient. It is used in respiratory conditions associated with excessive or viscous mucus and helps facilitate the clearance of mucus from the respiratory tract.
Bromhexine Hydrochloride is chemically identified as 2,4-dibromo-6-[[cyclohexyl(methyl)amino]methyl]aniline hydrochloride. It has the molecular formula C14H21Br2ClN2 and a molecular weight of approximately 412.59 g/mol. The CAS number is 611-75-6.
Bromhexine Hydrochloride is classified as a mucolytic/secretolytic agent and is used in pharmaceutical preparations for respiratory disorders associated with productive cough and abnormal mucus viscosity.
Product Name: Bromhexine Hydrochloride
CAS Number: 611-75-6
Molecular Formula: C14H21Br2ClN2
Molecular Weight: 412.59 g/mol
IUPAC Name: 2,4-dibromo-6-[[cyclohexyl(methyl)amino]methyl]aniline hydrochloride
Chemical Class: Substituted aniline / brominated amine
Therapeutic Category: Mucolytic / Respiratory API
Bromhexine Hydrochloride is used as a mucolytic agent in pharmaceutical formulations for respiratory disorders involving thick or excessive mucus. It promotes mucus clearance by reducing mucus viscosity and facilitating expectoration.
Bromhexine Hydrochloride occurs as a white or almost white crystalline powder. It is very slightly soluble in water and slightly soluble in alcohol and methylene chloride. The Japanese Pharmacopoeia describes it as freely soluble in formic acid, sparingly soluble in methanol, and slightly soluble in water and ethanol.
The reported melting/decomposition temperature is approximately 231–239 °C.
Appearance: White or almost white crystalline powder
Identification: IR / HPLC / chloride reaction
Assay (HPLC): 98.0%–102.0% on dried basis
Loss on Drying: NMT 1.0%
Residue on Ignition / Sulfated Ash: NMT 0.1%
Heavy Metals: NMT 10 ppm
pH: 3.0–5.0 for saturated solution
Individual Impurity: NMT 0.10% for unspecified impurities; impurity C NMT 0.15%
Total Impurities: NMT 0.20%
Water Content: 1.0% maximum
Specific Rotation: Not applicable
Melting Point: Approximately 231 °C, with decomposition
Solubility: Very slightly soluble in water; slightly soluble in alcohol and methylene chloride; freely soluble in formic acid
The current BP monograph identifies impurity C with a limit of NMT 0.15%, unspecified impurities at NMT 0.10% each, and total impurities at NMT 0.20%.
Bromhexine Hydrochloride API can be supplied in suitable pharmaceutical-grade packaging according to customer requirements, quantity and applicable pharmaceutical handling requirements.
Documentation may include Certificate of Analysis, product specification, safety documentation and technical documentation according to product grade and customer requirements.
Store Bromhexine Hydrochloride in well-closed containers, protected from light. The BP monograph specifically states protected-from-light storage.
Swapnroop Drugs & Pharmaceuticals supplies Bromhexine Hydrochloride API for pharmaceutical customers requiring quality-focused API sourcing and commercial supply support.
Contact Swapnroop Drugs & Pharmaceuticals for Bromhexine Hydrochloride availability, specifications, documentation, packaging and commercial supply information.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR / HPLC / Chloride reaction |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 3.0 – 5.0* |