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Product Name: Chlorpheniramine Maleate or Chlorphenamine Maleate
Chemical Formula: C16H19ClN2·C4H4O4
CAS Number: 113-92-8
Common Use: Antihistamine used to relieve allergy symptoms. Found in various cold and allergy medications.
Manufacturer: Multiple pharmaceutical suppliers worldwide deliver this compound for clinical and bulk pharmaceutical use.
Synonyms: Chlorphenamine Maleate, p-Chlorobenzylpyridylmethylamine Maleate
Contact for Emergency: Chemical safety office or appropriate emergency response line as per region.
Recommended Use and Restrictions: Use for professional or prescribed medical applications as directed by qualified individuals.
GHS Classification: Acute Toxicity - Oral (Category 4); Eye Irritation (Category 2A); Skin Sensitization (Category 1).
Signal Word: Warning
Hazard Statements: Harmful if swallowed, causes serious eye irritation, may cause an allergic skin reaction.
Pictograms: Exclamation mark for skin and eye irritation; Health hazard symbol for systemic health effects.
Routes of Exposure: Inhalation, ingestion, skin contact, eye contact.
Precautionary Statements: Avoid breathing dust, wash hands thoroughly after handling, use personal protective equipment as required, do not eat, drink, or smoke when using this product.
Potential Health Effects: Short-term exposure can lead to drowsiness, dry mouth, gastrointestinal discomfort, and eye or skin irritation; prolonged or high-level exposure may result in systemic antihistamine effects such as rapid heart rate, confusion, or increased risk of falls.
Substance: Chlorpheniramine Maleate
Concentration: Typically supplied as the pure active pharmaceutical ingredient (API)
Impurities: Possible trace amounts of related alkylamines or maleic acid by-products from synthesis
Additives: None unless part of formulated end products; for bulk substance, expect only the named compound.
Regulatory Listings: Listed as an approved pharmaceutical ingredient by FDA, EMA, and other global agencies.
Inhalation: Move to fresh air immediately. Support breathing and provide oxygen if any difficulty occurs. Seek medical attention for persistent symptoms.
Skin Contact: Remove contaminated clothing, wash affected area with plenty of water and soap. If irritation persists, consult a physician.
Eye Contact: Rinse cautiously with water for 15 minutes, holding eyelids open. Remove contact lenses if present and easy to do. Get medical attention for irritation or pain.
Ingestion: Rinse mouth thoroughly, do not induce vomiting unless advised by medical personnel. Obtain medical advice immediately as antihistamine overdose can cause harmful symptoms including drowsiness and confusion.
Suitable Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or foam. Choose fire-fighting media based on surrounding materials.
Special Hazards: Combustion may release toxic vapors such as hydrogen chloride, nitrogen oxides, and carbon monoxide.
Protective Equipment: Firefighters need self-contained breathing apparatus and full protective gear in environments with heavy smoke or fumes.
Advice for Firefighters: Avoid inhalation of combustion gases, work upwind, and prevent any runoff from entering drains or open water courses.
Personal Precautions: Wear gloves, protective clothing, and safety goggles. Avoid inhaling dust and prevent skin or eye contact.
Environmental Precautions: Prevent entry into waterways, sewers, and confined spaces.
Cleanup Methods: Sweep up gently or use industrial vacuum cleaner. Minimize dust formation and collect in suitable container for disposal. Ventilate area after cleanup.
Notification: Alert appropriate authorities in the case of significant releases or if contamination of waterways occurs.
Handling: Handle in a well-ventilated area, avoid dust generation, use standard pharmaceutical or laboratory safety protocols. Wear recommended PPE including gloves and goggles.
Storage Conditions: Keep container tightly closed, store in a dry, cool, well-ventilated location away from light and incompatible chemicals. Avoid exposure to moisture.
Incompatibilities: Keep away from strong oxidizing agents and acids. Avoid storing near food or animal feed.
Specific End Uses: Used for formulation into medicinal products or laboratory research with trained personnel oversight.
Control Parameters: No specific occupational exposure limits, but exposure should be minimized.
Engineering Controls: Use local exhaust ventilation or fume hood for large scale or bulk powder handling.
Personal Protective Equipment: Nitrile or latex gloves, safety goggles, lab coat or apron, dust mask or respirator if required.
Hygiene Measures: Wash hands thoroughly after handling, do not eat, drink, or smoke in working area, regularly clean work surfaces.
Appearance: White to slightly yellow crystalline powder
Odor: Odorless or faintly characteristic
Molecular Weight: 390.86 g/mol
Melting Point: 130–135°C (decomposition possible at higher temperatures)
Solubility: Freely soluble in water, ethanol, and slightly soluble in chloroform
pH: Aqueous solution typically mildly acidic (around 4–7)
Vapor Pressure: Negligible at room temperature
Partition Coefficient (logPow): Estimated at 0.5–1 (moderate hydrophilicity relative to lipophilicity)
Stability: Stable under normal handling and storage conditions if kept dry and away from light.
Conditions to Avoid: High humidity, excessive heat, exposure to strong oxidizers or acids.
Hazardous Reactions: None expected under recommended storage conditions, but strong oxidizers could produce hazardous byproducts.
Decomposition Products: Toxic gases including carbon oxide, nitrogen oxide, and hydrogen chloride in the case of fire or extreme degradation.
Acute Toxicity: LD50 (oral, rat) 193 mg/kg. Harmful if swallowed in significant quantity.
Routes of Exposure: Ingestion, inhalation, and skin or eye contact.
Symptoms of Overexposure: Drowsiness, dry mouth, blurred vision, rapid heartbeat, confusion, or, in severe cases, convulsions especially after overdose.
Chronic Effects: No evidence of carcinogenicity or long-term organ toxicity in small doses, but frequent use can increase risk of side effects including anticholinergic syndrome.
Allergenicity: Some individuals may develop skin sensitivity or allergic reactions.
Mutagenicity and Carcinogenicity: No evidence in standard laboratory testing.
Environmental Behavior: Limited studies suggest moderate persistence, potential for leaching into aquatic environments.
Ecotoxicity: Low expected toxicity to aquatic organisms based on structure, but pharmaceuticals can disrupt aquatic systems when present in significant concentrations.
Persistence and Degradability: Slow breakdown in water; waste treatment facilities may not fully remove this compound.
Bioaccumulation: Potential considered low, but continuous release through wastewater can result in chronic environmental exposure.
Mobility: High solubility in water increases risk of movement through environment after disposal.
Waste Treatment Methods: Do not dispose of in household garbage, drains, or natural water bodies.
Recommended Disposal: Collect waste material in properly labeled container; incinerate at a licensed hazardous waste facility.
Regulations: Follow local, regional, or national hazardous waste disposal regulations. Notify authorities if contamination occurs.
Unused Product Disposal: Small quantities from pharmacies may go through take-back programs, larger quantities from industry should use chemical hazardous waste services.
UN Number: Not classified as a hazardous substance for transport under UN regulations.
Transport Hazard Class: Not regulated as dangerous for most forms of transportation, but good practice involves secure packaging to prevent spills.
Packing Group: Not assigned.
Special Precautions: Clearly label containers, indicate pharmaceutical compound inside. Avoid shipping with food or incompatible chemicals.
Bulk Shipping: Use sealed, leak-proof packaging, and follow all company safety protocols.
FDA Status: Approved active pharmaceutical ingredient for over-the-counter and prescription drugs in the United States.
EU Regulations: Complies with EMA guidance for pharmaceutical products.
TSCA Status: Exempt for use as active pharmaceutical ingredient, not listed for general industrial application.
Workplace Safety: OSHA and similar agencies recommend limiting exposure to pharmaceuticals in workplace using personal protective equipment and engineering controls.
Inventory Listings: Registered in applicable pharmaceutical ingredient inventories in North America, Europe, Asia-Pacific.
Labeling Requirements: Product packaging and documentation must comply with country-specific pharmaceutical, occupational safety, and environmental protection laws.
