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Bromhexine HCL BP
Bromhexine HCL BP is a synthetic mucolytic agent, commonly used as an expectorant to treat respiratory disorders associated with excessive mucus. It appears as a white or slightly yellow crystalline powder that is soluble in water and alcohol. Bromhexine works by breaking down the structure of mucus, reducing its viscosity and facilitating easier expectoration. It is widely used in pharmaceutical formulations such as tablets, syrups, and injectables for respiratory conditions like bronchitis, asthma, and chronic obstructive pulmonary disease (COPD).
Bromhexine HCL BP
Primary Uses
- Pharmaceuticals
- Used as a mucolytic agent to liquefy and reduce the viscosity of sputum in patients with respiratory tract diseases.
- Formulated in oral tablets, syrups, and injectables to treat bronchitis, chronic obstructive pulmonary disease (COPD), asthma, and other mucus-related respiratory conditions.
- Enhances the effectiveness of antibiotics by improving mucus clearance.
- Medical & Clinical
- Used as an adjunctive therapy in respiratory infections to aid mucus clearance.
- Sometimes combined with other bronchodilators and anti-inflammatory agents for improved respiratory function.
Secondary Uses
- Veterinary Medicine
- Occasionally used in veterinary formulations to treat respiratory conditions in animals involving mucus accumulation.
- Research
- Utilized in pharmacological studies investigating mucolytic and respiratory therapies.
1. Basic Identification Attributes
- Chemical Name (IUPAC): trans-4-(2-Amino-3,5-dibromobenzyl)morpholine hydrochloride
- Common/Trade Name: Bromhexine Hydrochloride, Bromhexine HCL BP
- CAS Number: 611-75-6
- HS Code: 2933.39.00
- Molecular Formula: C14H20Br2N2O · HCl
- Synonyms:
- Bromhexine hydrochloride BP
- Bisolvon (brand name)
- Bromhexol hydrochloride
2. Physical & Chemical Properties
- Physical State: Crystalline powder
- Color & Odor: White or slightly yellow; odorless or faint characteristic odor
- Melting Point: 208–212°C (with decomposition)
- Boiling Point: Not applicable (decomposes)
- Density: Approx. 1.55 g/cm³
- Solubility: Freely soluble in water, sparingly soluble in ethanol, slightly soluble in chloroform
- pH: Acidic due to hydrochloride salt, pH ~3–4 in aqueous solution
- Stability: Stable under normal conditions; sensitive to moisture and light
3. Safety & Hazard Attributes
- Hazard Class (GHS): Not classified as hazardous under normal handling; mild irritant
- NFPA Ratings:
- Health: 1
- Flammability: 0
- Reactivity: 0
- Exposure Limits: No specific OSHA/ACGIH limits; avoid dust inhalation
- Toxicity: Low acute toxicity; overdose may cause gastrointestinal discomfort and CNS effects
- Reactivity: Stable; avoid strong oxidizing agents
4. Storage & Handling Attributes
- Storage Conditions: Store in a cool, dry place protected from light and moisture
- Container Type: Airtight containers such as HDPE or glass bottles
- Shelf Life: Typically 3–5 years if stored properly
- Special Handling: Use PPE when handling powder; avoid inhalation and prolonged skin contact
5. Regulatory & Compliance Attributes
- Pharmacopoeia Compliance: Complies with British Pharmacopoeia (BP) standards
- FDA Status: Approved for medicinal use in many countries as a prescription mucolytic agent
- Transportation: Not classified as hazardous
- Waste Disposal: Dispose according to pharmaceutical waste regulations
6. Environmental & Health Impact
- Ecotoxicity: Low; no significant environmental hazard reported
- Persistence: Organic compound; biodegrades under aerobic conditions
- Bioaccumulation: Not expected to bioaccumulate
- Carcinogenicity/Mutagenicity: Not classified as carcinogenic or mutagenic
- Biodegradability: Biodegradable in the environment
Safety Handling Precautions
Personal Protective Equipment (PPE):
- Gloves
- Protective goggles
- Dust mask or respirator (when handling powder)
- Lab coat or protective clothing
Handling Measures:
- Avoid inhalation of dust and skin contact
- Work in well-ventilated areas
- Use local exhaust ventilation if dust is generated
Storage Measures:
- Keep container tightly closed
- Protect from moisture and direct sunlight
Hygiene Practices:
- Wash hands thoroughly after handling
- Do not eat, drink, or smoke while handling
First Aid Measures
- Inhalation: Move to fresh air; seek medical attention if respiratory symptoms occur
- Skin Contact: Wash with soap and water; seek medical advice if irritation develops
- Eye Contact: Rinse thoroughly with water for at least 15 minutes; seek medical advice if irritation persists
- Ingestion: Rinse mouth; seek medical attention if large amounts ingested or if adverse symptoms occur
Firefighting Measures
- Fire Hazards: Non-flammable
- Extinguishing Media: Use water spray, foam, dry chemical, or CO₂ depending on surrounding fire
- Special Precautions: Firefighters should wear full protective gear and SCBA if needed
- Decomposition Products: May produce toxic gases including hydrogen chloride under extreme heat
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