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Diphenhydramine HCl
Diphenhydramine Hydrochloride (HCl) is a first-generation antihistamine with potent $H_1$-receptor antagonist properties.
Diphenhydramine HCl API – Pharmaceutical Grade | Manufacturer & Exporter from India
Diphenhydramine Hydrochloride (HCl) is a first-generation antihistamine with potent $H_1$-receptor antagonist properties. As a leading Diphenhydramine HCl Manufacturer, Shabbir Chemicals provides high-purity API to global pharmaceutical markets for use in allergy relief, sleep aids, and cough and cold formulations. It is highly valued for its multi-functional therapeutic profile, including sedative, antiemetic, and anticholinergic effects.
Product Overview
- Synonyms: 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride
- CAS No: 147-24-0
- Code: DPH-HCL
- Grade: USP / BP / EP / IP
- Mol. Formula: $C_{17}H_{21}NO \cdot HCl$
- Mol. Weight:291.82 g/mol
- Purity (Assay): 98.0% – 102.0% (on dried basis)
Description
Diphenhydramine HCl is a white or almost white, crystalline powder that is odorless and has a numbing effect on the tongue. It works by competing with free histamine for binding at $H_1$-receptor sites in the GI tract, uterus, large blood vessels, and bronchial muscle. It also crosses the blood-brain barrier, which accounts for its common use as a non-prescription sleep aid.
Applications
- Allergy Management: Relieves symptoms of hay fever, urticaria (hives), and the common cold.
- Sleep Aids: Used in OTC formulations to treat occasional insomnia due to its sedative properties.
- Antitussive: Acts as a cough suppressant in various syrup formulations.
- Motion Sickness: Effective in the prevention and treatment of nausea and dizziness.
- Parkinsonism: Used to treat drug-induced extrapyramidal symptoms and mild cases of Parkinson's disease.
Technical Specifications
| Test Item | Specification |
|---|---|
| Appearance | White or almost white crystalline powder |
| Solubility | Very soluble in water; freely soluble in alcohol and chloroform |
| Identification | Positive by IR and Chloride tests |
| Melting Point | 167°C to 172°C |
| Loss on Drying | Not more than 0.5% |
| Residue on Ignition | Not more than 0.1% |
| Heavy Metals | ≤ 20 ppm |
| Organic Impurities | Meets USP/BP limits |
Safety & Hazard Information
- Signal Word: Warning
- Hazard Statements: * H302: Harmful if swallowed.
- H336: May cause drowsiness or dizziness.
- Precautionary Statements:
- P261: Avoid breathing dust/fumes.
- P264: Wash hands thoroughly after handling.
- P301 + P312: IF SWALLOWED: Call a POISON CENTER if you feel unwell.
- Storage Requirement: Store in a cool, dry place. Keep container tightly closed and protected from direct sunlight and moisture.
Packaging & Logistics
- Standard Packaging: 25 kg Fiber Drums / HDPE Drums with double-layered LDPE inner liners.
- Shipping Name: Diphenhydramine Hydrochloride (Non-Hazardous for transport).
- Export Markets: Active supplier to North America, Europe, Middle East, and SE Asia.
- Regulatory Support: Comprehensive documentation provided, including COA, MOA, and Stability Studies.
Why Partner with Shabbir Chemicals?
Our Diphenhydramine HCl API is synthesized in a cGMP-compliant facility utilizing rigorous quality control measures. We ensure exceptionally low impurity profiles and consistent particle size distribution, making our API ideal for high-speed tableting and clear liquid syrup formulations.