Bromhexine Hydrochloride API Manufacturer China | ≥98% Mucolytic Expectorant Pharmaceutical Powder CAS 611-75-6

Key Selling Points

✓ Dual-Action Mucolytic - Secretolytic (Viscosity Reduction) + Secretomotor (Ciliary Clearance Enhancement)

✓ Breaks Acid Glycoprotein Fibers - Reduces Thick, Sticky Bronchial Mucus Viscosity

✓ Antibiotic Synergy - Increases Bronchial Mucus Antibiotic Concentrations >2× (e.g., Oxytetracycline)

✓ Wide Safety Margin - Minimal Side Effects, Well-Tolerated Across Species

✓ Multi-Species Veterinary Mucolytic - Cattle, Horse, Pig, Dog, Cat, Poultry (CRD, Bronchitis, Bronchopneumonia)

✓ Plant-Derived Synthetic Mucolytic - Derived from Vasicine (Adhatoda vasica), Established Since 1963

What Is Bromhexine Hydrochloride Powder?

Bromhexine Hydrochloride Powder (C₁₄H₂₁Br₂ClN₂, MW 412.59) is a synthetic mucolytic agent derived from vasicine, an alkaloid found in the Adhatoda vasica (malabar nut) plant. It has dual secretolytic and secretomotor actions: it reduces mucus viscosity by breaking down acid glycoprotein fiber networks in thick bronchial secretions, and enhances mucociliary clearance by stimulating ciliary epithelial activity. It also increases serous mucus secretion, making phlegm thinner and easier to expel.

It is widely used as a pharmaceutical and veterinary raw material for chronic bronchitis, bronchiectasis, asthma with viscous mucus, and respiratory infections in humans, and as a mucolytic adjunct in cattle, horses, pigs, dogs, cats and poultry (chronic respiratory disease, infectious bronchitis, bronchitis, bronchopneumonia). When combined with antibiotics (e.g., oxytetracycline), it increases antibiotic concentrations in bronchial mucus by more than 2-fold, enhancing antimicrobial efficacy.

How Does Bromhexine Hydrochloride Powder Work?

Bromhexine Hydrochloride Powder exerts mucolytic effects through two complementary mechanisms. First, as a secretolytic agent, it stimulates respiratory mucus glands to increase serous (watery) secretion and breaks down the network of acid glycoprotein fibers that give mucoid sputum its characteristic viscosity; it also increases lysosomal activity, enhancing hydrolysis of acid mucopolysaccharide polymers. Second, as a secretomotor agent, it enhances tracheobronchial ciliary activity, accelerating mucociliary clearance - the natural "conveyor belt" that moves mucus upward for expulsion.

Because Bromhexine Hydrochloride Powder increases both mucus volume and antibiotic penetration into bronchial secretions, it is often used as an adjunct to antimicrobial therapy in respiratory infections. It has a wide safety margin with minimal side effects. It is less effective in purulent bronchitis where mucus viscosity depends more on DNA than glycoproteins. It is not recommended for dry, non-productive cough. Metabolism is hepatic; excretion is primarily renal.

What Are the Applications of Bromhexine Hydrochloride Powder?

Human Respiratory: Chronic bronchitis, bronchiectasis, asthma with viscous mucus, pneumonia adjunct, sinusitis - mucus thinning and expectoration.
Bovine Respiratory: Bronchitis, bronchopneumonia and respiratory disease in cattle - shown to increase mucociliary clearance in calves.
Porcine Respiratory: Piglet influenza, respiratory infections, bronchitis in pigs.
Equine Respiratory: Bronchitis and recurrent airway obstruction (heaves) in horses.
Canine/Feline: Bronchitis, bronchopneumonia and respiratory infections with thick mucus in dogs and cats.
Poultry: Chronic respiratory disease (CRD), infectious bronchitis in chickens and turkeys.
Antibiotic Adjunct: Combined with oxytetracycline or other antibiotics to increase bronchial mucus antibiotic concentrations >2-fold.
Pharmaceutical Formulations: Raw material for tablets, oral solutions/syrups, injectable solutions, sachets and compounded mucolytic combinations.

What Is the Difference Between Bromhexine and Ambroxol?

Feature	Bromhexine	Ambroxol
CAS (HCl)	611-75-6	23828-92-4
Relationship	Parent compound	Active metabolite of bromhexine
Mechanism	Secretolytic + secretomotor	Secretolytic + surfactant stimulation + antioxidant
Mucus Viscosity Reduction	Yes (acid glycoprotein breakdown)	Yes (more potent)
Surfactant Stimulation	No	Yes (type II pneumocytes)
Antioxidant / Anti-Inflammatory	Minimal	Yes
Onset	~30–60 min	~30 min
Typical Use	General mucolytic, veterinary respiratory	More potent mucolytic, pediatric respiratory, bronchopulmonary dysplasia
Veterinary Use	Very common (multi-species)	Common (dogs, cats, horses)

How Does Bromhexine Compare With Other Mucolytics?

Feature	Bromhexine	Acetylcysteine (NAC)	Carbocisteine	Guaifenesin
CAS (HCl)	611-75-6	616-91-1	638-23-3	93-14-1
Mechanism	Glycoprotein breakdown + ciliary enhancement	Disulfide bond cleavage (mucolytic) + antioxidant	Glycoprotein synthesis modification	Expectorant (reflex vagal)
Mucus Thinning	Yes	Yes (strong)	Moderate	Mild (increases volume)
Antioxidant	No	Yes (glutathione precursor)	No	No
Route	Oral, injection	Oral, inhalation, injection	Oral	Oral
Typical Use	Veterinary respiratory, chronic bronchitis	Acetaminophen overdose, COPD, veterinary	COPD, chronic bronchitis	Common cold, cough mixtures
Veterinary Use	Multi-species common	Common (cats, dogs, horses)	Less common	Common (horses, cattle)

How Is Bromhexine Hydrochloride Powder Manufactured?

Bromhexine Hydrochloride Powder is manufactured through multi-step chemical synthesis involving bromination, amination and hydrochloride salt formation.

Raw Material QC → Starting Material (2-Aminobenzylamine / Vasicine Derivative) → Bromination (3,5-Dibromination) → N-Cyclohexyl-N-Methyl Amination → Crude Bromhexine Base → Purification (Recrystallization / Chromatography) → Hydrochloride Salt Formation (HCl) → Crystallization → Centrifugation → Drying → Milling → Final QC → Packaging

HDM BIO controls key bromination, amination and salt formation parameters to maintain consistent purity, particle size and batch quality.

Quality Specifications

Test Item	Standard	Typical Result
Appearance	White to off-white powder	Consistent
Assay (HPLC)	≥98.0%	99.0%
Identity (IR / HPLC)	Conforms to reference standard	Confirmed
Melting Point	240–244°C	242°C
Loss on Drying	≤0.5%	0.2%
Related Substances	Within specification	Pass
Heavy Metals	≤10 ppm	Compliant
Residual Solvents	Within specification	Pass
Sterility (injectable grade)	Sterile	Compliant
Bacterial Endotoxins (injectable grade)	≤0.5 EU/mg	Compliant

What Quality Control Tests Are Performed for Bromhexine Hydrochloride Powder?

Each batch undergoes multi-step quality control before release to verify identity, purity and key quality attributes.

Raw Material QC → In-Process Control → HPLC Assay → IR Identity Verification → Melting Point Determination → Loss on Drying → Related Substances (HPLC) → Heavy Metals → Residual Solvents → Sterility Test (injectable grade) → Bacterial Endotoxin Test (LAL, injectable grade) → Final Batch Release

Key evaluations include HPLC assay (≥98%), IR identity, melting point, loss on drying, related substances, heavy metals, residual solvents, and for injectable grade: sterility and bacterial endotoxin (LAL) testing. Every commercial batch is supported by a batch-specific COA and relevant analytical documentation for incoming QC and supplier qualification.

What Factors Affect Bromhexine Hydrochloride Powder Bulk Price?

Bromhexine Hydrochloride Powder bulk pricing is driven by several key factors:

Raw Material Costs: Bromination reagents and amine starting materials directly influence manufacturing expenses.
Purity & Grade: Injectable grade (sterile, endotoxin-controlled, ≥98%) commands a significant premium over oral/technical grade.
Sterility & Endotoxin Specification: Aseptic processing and LAL-tested batches for injection carry higher production costs.
Regulatory Compliance & Certification: GMP-standard API with DMF/CEP and consistent COA demands a higher price.
Order Volume: Large-scale pharmaceutical contracts receive steeper per-kilogram discounts.
Logistics & Geography: Light-protected / moisture-proof packaging and customs compliance add to the landed cost.

Contact HDM BIO for a current quotation and volume-based pricing.

Why Choose HDM BIO as Your Bromhexine Hydrochloride Powder Supplier?

High-purity (≥98% / typical 99%) mucolytic expectorant API for tablet, syrup, injectable and sachet formulations
Verified consistent melting point, low related substances and reliable quality
Dual-action secretolytic + secretomotor mucolytic with proven antibiotic synergy in bronchial mucus
GMP-aligned production, ISO & HACCP certified quality system
Full batch traceability and complete documentation (COA, MSDS, HPLC, sterility, LAL)
Flexible supply: kilogram samples to ton-level bulk API orders
Global export to 70+ countries with full customs support

Bulk Packaging, Shipping & Storage

Packaging: Foil bags for samples and moisture-proof fiber drums for bulk orders.
Custom Packaging: OEM labeling available.
Shipping Documents: COA, MSDS/SDS, commercial invoice, packing list and customs documentation available according to order requirements.
Storage: Store tightly sealed in a cool, dry, light-protected environment. Shelf life: 24 months.
Handling: For pharmaceutical/veterinary raw material use only; not for direct clinical administration.

Frequently Asked Questions About Bromhexine Hydrochloride Powder

Q1: What is Bromhexine Hydrochloride Powder?

A: Bromhexine hydrochloride is a synthetic mucolytic agent derived from vasicine (an alkaloid from Adhatoda vasica). It has dual secretolytic and secretomotor actions: it reduces mucus viscosity by breaking acid glycoprotein fibers in thick bronchial secretions, and enhances mucociliary clearance by stimulating ciliary activity. Used for chronic bronchitis, bronchiectasis, asthma with viscous mucus, and veterinary respiratory infections.

Q2: What is the CAS number?

A: 611-75-6.

Q3: How does bromhexine hydrochloride work?

A: It stimulates respiratory mucus glands to increase serous (watery) secretion and breaks down acid glycoprotein fiber networks that give thick sputum its viscosity (secretolytic). It also enhances tracheobronchial ciliary activity, accelerating mucus clearance (secretomotor). It increases lysosomal activity to hydrolyze acid mucopolysaccharides and can increase antibiotic concentrations in bronchial mucus >2-fold.

Q4: What is bromhexine hydrochloride used for?

A: Human: chronic bronchitis, bronchiectasis, asthma with viscous mucus, pneumonia adjunct, sinusitis. Veterinary: respiratory disease with thick mucus in cattle, horses, pigs, dogs, cats and poultry (CRD, infectious bronchitis, bronchitis, bronchopneumonia). Often combined with antibiotics (e.g., oxytetracycline) to enhance bronchial mucus antibiotic penetration.

Q5: What documents are provided with each batch?

A: Batch-specific COA, HPLC assay report, IR identity, melting point, loss on drying, related substances, heavy metals, residual solvents, and for injectable grade: sterility and LAL endotoxin results, MSDS/SDS.

Q6: What purity do you supply?

A: Standard ≥98.0% HPLC; typical batch result 99%. Injectable grade with sterility and endotoxin specification available on request.

Q7: Where can I buy it from China?

A: HDM BIO supplies bulk Bromhexine Hydrochloride Powder with batch COA and global export support.

Q8: How much does Bromhexine Hydrochloride Powder cost?

A: Bulk pricing depends on raw material costs, purity/grade (oral vs injectable), sterility/endotoxin specification, regulatory compliance, order volume and logistics. Contact HDM BIO for a current quotation.

Q9: Are there any safety concerns?

A: Wide safety margin with minimal side effects. Occasional GI discomfort (nausea, vomiting, diarrhea) and rare allergic reactions (rash) may occur. Contraindications: hypersensitivity to bromhexine, pulmonary edema (do not use in animals with pulmonary edema). Use caution in gastric ulcer patients (may irritate gastric mucosa). Not recommended for dry, non-productive cough. Pregnancy: generally considered safe but use caution in first trimester. Not for direct clinical administration.

Q10: What is the difference between bromhexine and ambroxol?

A: Ambroxol is the active metabolite of bromhexine. Both are mucolytics, but ambroxol is more potent and additionally stimulates pulmonary surfactant production and has antioxidant/anti-inflammatory effects. Bromhexine has a longer track record in veterinary multi-species use and proven antibiotic synergy in bronchial mucus. Ambroxol is more commonly used in pediatric respiratory and bronchopulmonary dysplasia.