Diphenhydramine HCL BP

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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.

Description

Diphenhydramine HCL BP Uses

Primary Uses 
  1. 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.

  1. 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.

  1. Motion Sickness & Nausea

  • Used in oral and injectable forms to prevent and treat nausea, vomiting, and dizziness caused by motion sickness or vertigo.

  1. Parkinsonism and Extrapyramidal Symptoms

  • Helps reduce tremors and muscle stiffness associated with Parkinson’s disease and drug-induced extrapyramidal symptoms.

  1. 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 Uses 
  1. Cough Suppressants

  • Included in some cough and cold formulations for its sedative and mild antitussive properties.

  1. Anesthetic Adjunct

  • Occasionally used in combination with other drugs for local anesthesia potentiation due to its anticholinergic effects.

  1. Treatment of Allergic Conjunctivitis

Utilized in ophthalmic formulations to relieve itching and redness caused by allergic conjunctivitis.

PRODUCT KEY FEATURES
  1. 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)

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

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