Shandong Huashang Chemical Co., Ltd. is a high-tech enterprise specializing in the research and development, manufacturing, and sales of fine chemicals. Headquartered in Jinan, Shandong, China, we are committed to delivering high-quality products to our global partners. Currently, over 90% of our products are exported to developed markets, including North America, Europe, Japan, South Korea, and the Middle East.
Product Description
Doxylamine succinate (CAS: 562-10-7) is an organic compound belonging to the class of ethanolamine antihistamines, which is the succinate salt of doxylamine. It appears as a white to off-white crystalline powder, odorless or with a faint characteristic odor, and is freely soluble in water and ethanol. As a first-generation antihistamine, it exerts competitive antagonism on histamine H1 receptors, with significant sedative, antihistaminic, and anticholinergic effects. It is widely used in the pharmaceutical industry, mainly for relieving allergic symptoms and treating insomnia, and is also a common component in over-the-counter (OTC) cold and sleep-aid medications.
Uses
Pharmaceutical Industry (Main Use): Primarily used for the symptomatic treatment of allergic rhinitis, urticaria, pruritus, and other allergic skin diseases, relieving symptoms such as sneezing, runny nose, skin itching, and erythema. It is also used as a sedative-hypnotic drug to treat occasional insomnia, especially insomnia caused by allergies or mild anxiety, with a rapid onset of action (30–60 minutes) and a duration of 4–6 hours.
OTC Medication Component: Commonly formulated with decongestants, antitussives, and analgesics in cold and flu medications to relieve allergic symptoms (such as nasal congestion, sneezing) and assist in improving sleep quality during illness. It is also available as a single-ingredient OTC sleep-aid medication for short-term use.
Other Applications: Used in combination with pyridoxine (vitamin B6) for the treatment of nausea and vomiting during pregnancy (morning sickness), under medical supervision. It is also used in pharmaceutical research as an analytical standard and in pharmacokinetic studies related to antihistamine drugs.
Molecular Formula & Structure
- Molecular Formula: C??H??N?O?
- Molecular Weight: 388.46 g/mol
- IUPAC Name: 2-[2-(Diphenylmethoxy)ethyl](dimethyl)ammonium butanedioate
- Synonyms: Doxylamine succinate salt; Decapryn; Unisom; 2-(Diphenylmethoxy)-N,N-dimethylethanamine succinate
- EINECS Number: 209-228-9
- Chemical Structure: It is the succinate salt formed by the reaction of doxylamine (a tertiary amine antihistamine) with succinic acid, with a diphenylmethoxy group and a dimethylaminoethyl group in its structure, which is the basis for its antihistaminic and sedative effects.
Physical & Chemical Properties
- Appearance: White to off-white crystalline powder; odorless or with a faint characteristic odor; no visible impurities.
- Melting Point: 103–107 °C (lit.).
- Boiling Point: Not explicitly reported; decomposes at high temperatures (above 200 °C).
- Density: Approximately 1.15 g/cm3 (at 25 °C).
- Flash Point: 230.1 °C (closed cup).
- Vapor Pressure: 3.71×10?1? mmHg at 25 °C.
- Solubility: Freely soluble in water (≥ 100 mg/mL at 25 °C), ethanol, and methanol; slightly soluble in chloroform; practically insoluble in ether and non-polar organic solvents.
- Stability: Stable under normal temperature and dry conditions; sensitive to light and moisture; should be stored in a cool and dark environment; incompatible with strong oxidants and strong acids; stable in neutral and weakly acidic environments.
- Chemical Traits: It is a tertiary amine salt, with good water solubility due to the succinate group; it can dissociate into doxylamine cations and succinate anions in aqueous solution; it has weak anticholinergic activity and sedative effects, which are related to its ability to cross the blood-brain barrier.
- Toxicity: Low acute toxicity; LD?? (oral, rat): 508 mg/kg; LD?? (intraperitoneal, mouse): 248 mg/kg. Adverse reactions are mainly mild, including drowsiness, dizziness, dry mouth, blurred vision, and constipation; overdose may cause confusion, tachycardia, and respiratory depression. Contraindicated in patients allergic to doxylamine succinate, glaucoma patients, and patients with benign prostatic hyperplasia; caution is required in pregnant women, lactating women, and children under 12 years old.
Synthesis & Storage
- Synthesis: Prepared by the reaction of diphenylmethanol with 2-dimethylaminoethyl chloride to obtain doxylamine free base, which is then reacted with succinic acid in ethanol solution for salification, followed by crystallization, filtration, drying, and purification processes. The product quality meets USP, EP, and CP standards, suitable for industrial production of pharmaceutical preparations.
- Storage: Sealed in dry, airtight containers; stored at 2–8 °C in a dark, dry place; avoid moisture, high temperature, and direct sunlight; keep away from oxidants and strong acids; shelf life is about 2 years under proper storage conditions; avoid mixing with food and feed.
- Safety: Operate in a well-ventilated and dry environment; wear sterile protective gear (gloves, goggles, mask); avoid inhalation of dust and skin/eye contact; wash hands thoroughly with soap and water after handling; if accidentally inhaled or in contact with eyes, rinse immediately with plenty of water and seek medical attention if irritation persists; dispose of waste in accordance with pharmaceutical waste regulations.
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