Diphenhydramine HCL BP

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Diphenhydramine HCL BP 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.

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Category: Active Pharmaceutical Ingredients (APIs) Tags: BP grade antihistamine, Diphenhydramine Hydrochloride, Drug manufacturing, Pharmaceutical ingredient, Pharmaceutical raw materials

Description

Table of Contents

Diphenhydramine HCL BP

Primary Uses

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 Uses

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.

KEY PRODUCT 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)

2. 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

3. 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

4. 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

5. 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

6. 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 CO₂ to extinguish fire
Special Precautions: Firefighters should wear self-contained breathing apparatus (SCBA)
Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides on combustion