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Pharmaceutical Chemistry
Diphenhydramine Hydrochloride (Dimedrol)
Formula:
C17H21NO
GOST/CAS:
CAS 147-24-0
Diphenhydramine Hydrochloride is a highly effective Active Pharmaceutical Ingredient (API) belonging to the class of first-generation antihistamines. The product is a white or almost white, crystalline, odorless or nearly odorless powder with a bitter taste, causing a temporary numbing sensation on the tongue. Due to its pronounced H1-antihistamine, sedative, local anesthetic, and antispasmodic properties, Diphenhydramine serves as an essential base raw material for manufacturing a wide range of medications in the modern pharmaceutical industry.
Applications
Production of Finished Dosage Forms (FDF): Used as a core active ingredient in the manufacturing of tablets, solutions for injection (ampoules), suppositories, as well as topical ointments and gels.
Antiallergic Medications: Incorporated into formulations designed to treat urticaria (hives), hay fever, serum sickness, angioedema (Quincke's edema), allergic conjunctivitis, and pruritic dermatoses.
Combination Sedatives & Analgesics: Included in combined pharmaceutical formulations (including lytic cocktails) to potentiate the effect of analgesics and achieve a distinct sedative or somniferic (sleep-inducing) effect.
Cold & Flu Relief Formulations: Added to multi-component powders and syrups to reduce capillary permeability, eliminate edema of the nasopharyngeal mucosa, and alleviate rhinitis symptoms.
Key Advantages
Multi-Targeted Mechanism of Action: Combines potent antihistamine efficacy with central and peripheral anticholinergic activity. This ensures rapid relief of smooth muscle spasms, reduction of capillary permeability, and effective itch suppression.
High Pharmaceutical Purity: The substance is manufactured in strict compliance with GMP and major Pharmacopoeia standards, guaranteeing minimal impurity profiles and excellent stability in finished dosage forms.
Rapid Therapeutic Response: Features high bioavailability. When utilized in injectable forms, it provides almost instantaneous management of acute allergic reactions and anaphylactic conditions.
Excellent Formulation Compatibility: Highly soluble in water and alcohol, allowing it to blend seamlessly with various other APIs, including metamizole (analgin), papaverine, and traditional antispasmodics.
Storage & Transportation
- Store in dry, clean, light-protected warehouse facilities in tightly closed original packaging (light-resistant bags/drums), out of reach of children, and strictly separated from food products.
- Recommended storage temperature range: +15°C to +25°C. Avoid exposure to direct sunlight, moisture, and excessive heat.
- The substance is classified as a potent pharmaceutical ingredient. Transportation and storage must comply strictly with local regulatory requirements governing the circulation of medicines and APIs.
- Shelf life — 3 to 5 years from the date of manufacture (depending on the manufacturer's specifications and packaging type).
Technical Specifications
Appearance
White or almost white crystalline powder, hygroscopic.
Assay (On dried basis)
99.0% – 101.0%
Melting Point
167°C – 172°C
Loss on Drying
Not more than 0.5%
Sulfated Ash
Not more than 0.1%
pH (5% aqueous solution)
4.0 – 5.5
Residual Solvents
Meets Pharmacopoeia requirements
Supply info
- Fiber or plastic drums with a double internal polyethylene liner: 10 kg / 25 kg.
- Small-scale hermetic packaging is available upon request for laboratory use and pilot-scale batches.
- Delivery is carried out via specialized transport ensuring full safety compliance for pharmaceutical raw materials. A comprehensive documentation package is provided (CoA, GMP/ISO, MSDS).