Doxylamine Succinate API

About Doxylamine Succinate API

Doxylamine is a first-generation antihistamine. It can be used by itself as a short-term sedative and in combination with other drugs to provide night-time allergy and cold relief. Doxylamine is also used in combination with the analgesics paracetamol (acetaminophen) an analgesic/calmative preparation, and is prescribed in combination with vitamin B6 (pyridoxine) to prevent morning sickness in pregnant women.

Specification:

Test Items	Specifications	Results
Appearance	White or almost white crystalline powder	Conform
Solubility	Very soluble in water, freelysoluble in alcohol	Conform
Identification	1)    Melting range:103-108 2)    Ultraviolet absorption: UVmax=262.0nm 3)    Organic Nitrogenous Bases 4)    Succinic acid melting range:184-188	105 262.0 nm   Conform   186-188
Loss on drying	<0.5%	0.3%
Residue on ignition	<0.1%	0.1%
Related substances(GC)	Total impurities<2.0% Single impurity<1.0%	1.9% 1.0%
Residual solvents	Diethyl ether<0.5% Acetone<0.5% Iso-propyl ether<0.5%	0.4% 0.4% 0.4%
Assay	98.0%-101.0% (Calculated on anhydrous substance)	99.2%

 

Packaging details:

 

Packaging details:	25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.
Storage:	Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat
Shelf Life:	5 years if sealed and store away from direct sun light.

Versatile Applications in General Medicine

Doxylamine Succinate is valued in the pharmaceutical industry for its effectiveness as an antihistamine. Commonly included in general medicine products, it helps manage symptoms caused by allergies, such as runny nose and sneezing. Its versatility in liquid and powder forms allows for various formulations suited to medical needs. The API is trusted by healthcare professionals throughout India.


Proper Storage Ensures Maximum Potency

To preserve Doxylamine Succinate's efficacy, it should be stored at room temperature in a cool, dry environment. Following this guideline protects against moisture and temperature fluctuations that could degrade the product. Distributors, wholesalers, and pharmacies are recommended to adhere to these conditions to ensure the medicine remains effective for patients.