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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) and codeine as 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% Toluene≤0.1% |
0.4% 0.4% 0.4% 0.1% |
|
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. |
