Bromhexine HCL BP

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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).

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Categories: Active Pharmaceutical Ingredients (APIs), Excipients Tags: Bromhexine hydrochloride, Cough medicine ingredient, Mucus thinner, Pharmaceutical Raw Material, Respiratory medicine, Syrup and tablet formulation

Description

Table of Contents

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.

PRODUCT KEY FEATURES

3. Key Attributes

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

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