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. |
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