USP31--A3专论.doc

Amantadine Hydrochloride C10H17N·HCl 187.71 Tricyclo[3.3.1.1.3,7]decan-1-amine, hydrochloride. 1-Adamantanamine hydrochloride [665-66-7]. ? Amantadine Hydrochloride contains not less than 98.5 percent and not more than 101.5 percent of C10H17N·HCl. Packaging and storage— Preserve in well-closed containers. USP Reference standards 11— USP Amantadine Hydrochloride RS. Clarity and color of solution— Dissolve 2 g in 10 mL of water: the solution is clear and nearly colorless. Identification, Infrared Absorption 197S— Cell: 1 mm. Solution— Dissolve about 50 mg in 10 mL of 0.1 N hydrochloric acid, and filter. Transfer the filtrate to a suitable separator, add 1 mL of 5 N sodium hydroxide, and extract with 5 mL of methylene chloride. pH 791: between 3.0 and 5.5, in a solution (1 in 5). Heavy metals, Method I 231— Use 1 mL of 1 N acetic acid in the Test Preparation: the limit is 0.001%. Chromatographic purity— Internal standard solution— Transfer about 500 mg of adamantane, accurately weighed, to a 10-mL volumetric flask, dissolve in and dilute with dichloromethane to volume, and mix. Test solution— Transfer about 1.0 g of Amantadine Hydrochloride, accurately weighed, to a separator. Add 20 mL of 5.0 N sodium hydroxide and 18 mL of dichloromethane, and shake for 10 minutes. Remove the water layer, dry the organic layer by swirling with anhydrous sodium sulfate, and allow to stand for a few minutes to ensure that all remaining water has been removed. Filter, collect the filtrate in a 20-mL volumetric flask, add 0.2 mL of Internal standard solution, and dilute with dichloromethane to volume. Standard solution— Transfer about 10 mg of USP Amantadine Hydrochloride RS, accurately weighed, to a separator. Add 20 mL of 5.0 N sodium hydroxide and 18 mL of dichloromethane, and shake for 10 minutes. Remove the water layer, dry the organic layer by swirling with anhydrous sodium sulfate, and allow to stand for a few minutes to ensure that all remaining water has been re