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  • Title: [On the galenical development of a nose spray from N-(2-imidazolin-2-yl)-N-(4-indanyl)amine monohydrochloride (indanazoline) (author's transl)].
    Author: Dechow HJ, Lämmerhirt K, Pich CH, Schikarski M.
    Journal: Arzneimittelforschung; 1980; 30(10):1738-46. PubMed ID: 6159899.
    Abstract:
    An account if given of the aim of the galenical development of the new remedy, indanazolin nose-spray. The description of the quality of the active ingredient N-(2-imidazolin-2-yl)-N-(4-indanyl)amine monohydrochloride (indanazoline, Farial) and the dosage form allows a pharmaceutical evaluation. The descriptions of the organoleptic, physical and chemical properties of the active substance are given in detail. The formulation, the procedures for manufacturing, and the specifications for the packaging materials give some idea of the galenical aspects. The quality of the finished dosage form is defined by means of product specifications relating to the identity, purity, and potency, and is proved by suitably designed stability studies. Finally a detailed summary is made of the analytical methods which were used.
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