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Azelastine hydrochloride

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Azelastine hydrochloride Basic information
Azelastine hydrochloride Chemical Properties
  • Melting point:225--2290C
  • storage temp. -20°C Freezer
  • solubility DMSO: >10mg/mL
  • form powder
  • color white to off-white
  • Merck 14,906
  • Stability:Incompatible with strong oxidizing agents.
  • CAS DataBase Reference79307-93-0(CAS DataBase Reference)
Safety Information
  • Hazard Codes Xn
  • Risk Statements 22
  • RTECS TH9203900
  • HS Code 2933992600
  • ToxicityLD50 in male, female mice, male, female rats (mg/kg): 36.5, 35.5, 26.9, 30.3 i.v.; 56.4, 42.8, 43.2, 46.6 i.p.; 63.0, 54.2, 66.5, 59.6 s.c.; 124, 139, 310, 417 orally (Zechel)
Azelastine hydrochloride Usage And Synthesis
  • DescriptionAzelastine hydrochloride is an orally effective antihistamine useful in the treatment of asthma and nasal allergy. It appears to inhibit release of histamine, in addition to antagonizing its action.
  • Chemical PropertiesWhite or almost white, crystalline powder.
  • OriginatorAsta-Werke(Degussa) (W. Germany)
  • UsesOrally active H1-hystamine receptor antagonist. Antihistaminic
  • DefinitionChEBI: The hydrochloride salt of azelastine.
  • brand nameAstelin (Medpointe); Optivar (Medpointe);AZEPTIN.
  • General Description(±)-4-[(4-chlorophenyl)methyl]-2-(hexahydro-l-methyl-1H-azepin-4-yl)-l-(2H)-phthalazinone monohydrochloride (Optivar), is a whitecrystalline powder that is sparingly soluble in water,methanol, and propylene glycol and slightly soluble inethanol, octanol, and glycerine. The commercial preparationis available as a 0.05% sterile ophthalmic solution fortopical administration to the eyes. Each milliliter of azelastinesolution contains 0.5-mg azelastine hydrochlorideequivalent to 0.457 mg of azelastine base, the preservativebenzalkonium chloride (0.125 mg), and inactive ingredientsincluding disodium edetate dihydrate, hydroxypropylmethylcellulose,sorbitol solution, sodium hydroxide, andwater for injection. The solution has a pH of approximately5.0 to 6.5 and an osmolality of approximately 271to 312 mOsm/L.
    The recommended dose of azelastine solution is 1 dropinstilled into each affected eye twice a day. This drugproduct is for ocular administration only and not for injectionor oral use. Absorption of azelastine following ocularadministration is relatively low (less than 1 ng/rnL).Absorbed drug undergoes extensive oxidative N-demethylationby CYP, and the parent drug and metabolite are eliminatedprimarily in the feces. The most frequently reportedadverse reactions are transient eye burning or stinging,headaches, and bitter taste. Azelastine solution should beused with caution during pregnancy or while nursing, becauseits safety has not been studied under these circumstances.
  • Safety ProfilePoison by ingestion andintravenous routes. An experimental teratogen. Otherexperimental reproductive effects. When heated todecomposition it emits toxic fumes of NOx and HCl.
Azelastine hydrochloride(79307-93-0)Related Product Information
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