Diphenhydramine HCL BP
Diphenhydramine Hydrochloride (HCL) is a first-generation antihistamine with potent anticholinergic, sedative, and antiemetic properties. It is commonly used to relieve symptoms associated with allergies, hay fever, the common cold, and motion sickness. Diphenhydramine HCL is a white crystalline powder, highly soluble in water, making it suitable for oral, topical, and injectable pharmaceutical formulations. Due to its ability to cross the blood-brain barrier, it causes sedation and is often used as a sleep aid and for managing Parkinson’s disease symptoms.
Diphenhydramine HCL BP Uses
Primary UsesÂ
- Pharmaceuticals – Allergy Treatment
- Used as an antihistamine to treat allergic reactions including rhinitis, urticaria, and pruritus.
- Effective in relieving symptoms such as sneezing, runny nose, itching, and watery eyes.
- Sleep Aid & Sedative
- Commonly formulated in over-the-counter (OTC) sleep aids for short-term treatment of insomnia.
- Employed for its sedative effect in preoperative medication to reduce anxiety and induce drowsiness.
- Motion Sickness & Nausea
- Used in oral and injectable forms to prevent and treat nausea, vomiting, and dizziness caused by motion sickness or vertigo.
- Parkinsonism and Extrapyramidal Symptoms
- Helps reduce tremors and muscle stiffness associated with Parkinson’s disease and drug-induced extrapyramidal symptoms.
- Topical Applications
- Used in topical creams, gels, and sprays for its local anesthetic and antipruritic effects to relieve insect bites, minor burns, and skin irritations.
Secondary UsesÂ
- Cough Suppressants
- Included in some cough and cold formulations for its sedative and mild antitussive properties.
- Anesthetic Adjunct
- Occasionally used in combination with other drugs for local anesthesia potentiation due to its anticholinergic effects.
- Treatment of Allergic Conjunctivitis
Utilized in ophthalmic formulations to relieve itching and redness caused by allergic conjunctivitis.
- Basic Identification Attributes
- Chemical Name (IUPAC): 2-(Diphenylmethoxy)-N,N-dimethylethanamine hydrochloride
- Common/Trade Name: Diphenhydramine Hydrochloride, Diphenhydramine HCL
- CAS Number: 147-24-0
- HS Code: 2933.39.00
- Molecular Formula: C17H21NO·HCl
- Synonyms:
- Diphenhydramine HCL
- Diphenhydramine hydrochloride
- Benadryl (common brand)
- Physical & Chemical Properties
- Physical State: White crystalline powder
- Odor: Odorless or faint characteristic odor
- Melting Point: 165–168°C (decomposes)
- Solubility: Freely soluble in water, ethanol; slightly soluble in chloroform
- Stability: Stable under normal storage conditions; sensitive to light and moisture
- Safety & Hazard Attributes
- Hazard Class (GHS): Not classified as hazardous under normal handling
- Toxicity: Low acute toxicity; overdose may cause severe sedation or anticholinergic toxicity
- Exposure Limits: No specific occupational exposure limit established
- Storage & Handling Attributes
- Storage Conditions: Store in a cool, dry, well-ventilated place, protected from light and moisture
- Container Type: Sealed HDPE or glass containers to prevent moisture ingress
- Shelf Life: Typically 2–3 years if stored properly
- Handling Precautions: Avoid dust inhalation; use PPE to prevent eye and skin contact
- Regulatory & Compliance Attributes
- Listed in pharmacopeias such as BP, USP, EP
- Approved for use in pharmaceuticals worldwide under controlled dosages
- Subject to prescription and OTC regulations depending on jurisdiction
- Environmental & Health Impact
- Ecotoxicity: Low toxicity to aquatic life at environmental concentrations
- Persistence: Biodegradable under typical wastewater treatment
- Bioaccumulation: Not expected
Carcinogenicity/Mutagenicity: Not classified as carcinogenic or mutagenic
Safety Handling Precautions
PPE Required:
- Dust mask or respirator (for powder handling)
- Safety goggles
- Gloves (nitrile or latex)
- Lab coat or protective apron
Handling Guidelines:
- Handle in well-ventilated areas
- Avoid creating dust and inhalation exposure
- Use non-metallic tools to prevent contamination
- Wash hands thoroughly after handling
Storage Measures:
- Keep container tightly closed
- Store away from moisture and direct sunlight
- Avoid exposure to high temperatures
Hygiene Practices:
- Do not eat, drink, or smoke while handling
- Use clean areas to prevent cross-contamination
- Remove contaminated clothing promptly
First Aid Measures
- Inhalation: Move to fresh air; if symptoms such as dizziness or headache occur, seek medical advice
- Skin Contact: Wash affected area with soap and water; consult physician if irritation develops
- Eye Contact: Rinse eyes with plenty of water for at least 15 minutes; seek medical attention if irritation persists
- Ingestion: Seek immediate medical attention; do not induce vomiting unless directed by medical personnel
Firefighting Measures
- Fire Hazards: Combustible material; may burn under fire conditions
- Extinguishing Media: Use water spray, dry chemical, foam, or COâ‚‚ to extinguish fire
- Special Precautions: Firefighters should wear self-contained breathing apparatus (SCBA)
Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides on combustion