Kanamycin Sulphate<\/p>\n
(Kanamycin Monosulfate, Ph. Eur. monograph 0032)<\/p>\n
C18<\/sub>H38<\/sub>N4<\/sub>O15<\/sub>S,H2<\/sub>O\u00a0 \u00a0 \u00a0 601\u00a0 \u00a0 \u00a0 \u00a05965-95-7<\/p>\n Action and use<\/strong><\/p>\n Aminoglycoside antibacterial.<\/p>\n 6-O-(3-Amino-3-deoxy-\u03b1-D-glucopyranosyl)-4-O-(6-amino-6-deoxy-\u03b1-D-glucopyranosyl)-2-deoxy-D-streptamine sulfate monohydrate.<\/p>\n Antimicrobial substance produced by the growth of certain strains of Streptomyces kanamyceticus.<\/p>\n Minimum 750 IU\/mg (dried substance).<\/p>\n It is produced by methods of manufacture designed to eliminate or minimise substances lowering blood pressure.<\/p>\n White or almost white, crystalline powder.<\/p>\n Freely soluble in water, practically insoluble in acetone and in ethanol (96 per cent).<\/p>\n A. Thin-layer chromatography (2.2.27).<\/p>\n Test solution: Dissolve 10 mg of the substance to be examined in water R and dilute to 10 mL with the same solvent.<\/p>\n Reference solution (a): Dissolve 10 mg of kanamycin monosulfate CRS in water R and dilute to 10 mL with the same solvent.<\/p>\n Reference solution (b): Dissolve 10 mg of kanamycin monosulfate CRS, 10 mg of neomycin sulfate CRS and 10 mg of streptomycin sulfate for identification CRS in water R and dilute to 10 mL with the same solvent.<\/p>\n Plate: Suitable plate coated with a 0.75 mm layer of a mixture prepared as follows: mix 0.3 g of carbomer R with 240 mL of water R and allow to stand, with moderate shaking, for 1 h; adjust to pH 7 by the gradual addition, with continuous shaking, of dilute sodium hydroxide solution R and add 30 g of silica gel H R.<\/p>\n Pretreatment: Heat the plate at 110 \u00b0C for 1 h, allow to cool and use immediately.<\/p>\n Mobile phase: 70 g\/L solution of potassium dihydrogen phosphate R.<\/p>\n Application: 10 \u03bcL.<\/p>\n Development: Over a path of 12 cm.<\/p>\n Drying: In a current of warm air.<\/p>\n Detection: Spray with a mixture of equal volumes of a 2 g\/L solution of 1,3-dihydroxynaphthalene R in ethanol (96 per cent) R and a 460 g\/L solution of sulfuric acid R. Heat at 150 \u00b0C for 5 min to 10 min.<\/p>\n System suitability: Reference solution (b):<\/p>\n \u2014 the chromatogram shows 3 clearly separated spots.<\/p>\n Results: The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a).<\/p>\n B. Dissolve 0.5 g in 10 mL of water R. Add 10 mL of picric acid solution R. Initiate crystallisation if necessary by scratching the wall of the tube with a glass rod and allow to stand. Collect the crystals, wash with 20 mL of water R and filter. Dry at 100 \u00b0C. The crystals melt (2.2.14) at about 235 \u00b0C, with decomposition.<\/p>\n C. Dissolve about 50 mg in 2 mL of water R. Add 1 mL of a 10 g\/L solution of ninhydrin R and heat for a few minutes on a water-bath. A violet colour develops.<\/p>\n D. It gives the reactions of sulfates (2.3.1).<\/p>\n Dissolve 0.20 g in carbon dioxide-free water R and dilute to 20.0 mL with the same solvent.<\/p>\n 6.5 to 8.5 for solution S.<\/p>\n + 112 to + 123 (dried substance), determined on solution S.<\/p>\n Thin-layer chromatography (2.2.27) as described under Identification A with the following modifications.<\/p>\n Test solution: Dissolve 0.1 g of the substance to be examined in water R and dilute to 20 mL with the same solvent.<\/p>\n Reference solution: Dissolve 4 mg of kanamycin B sulfate CRS in water R and dilute to 20 mL with the same solvent.<\/p>\n Application: 4 \u03bcL.<\/p>\n Detection: Spray with ninhydrin and stannous chloride reagent R. Heat at 110 \u00b0C for 15 min.<\/p>\n Limit:<\/p>\n \u2014 kanamycin B: any spot corresponding to kanamycin B in the chromatogram obtained with the test solution is not more intense than the spot in the chromatogram obtained with the reference solution (4.0 per cent).<\/p>\n Maximum 1.5 per cent, determined on 1.000 g by drying at 60 \u00b0C at a pressure not exceeding 670 Pa for 3 h.<\/p>\n Maximum 0.5 per cent, determined on 1.0 g.<\/p>\n 15.0 per cent to 17.0 per cent of sulfate (dried substance).<\/p>\n Dissolve 0.250 g in 100 mL of water R and adjust the solution to pH 11 with concentrated ammonia R. Add 10.0 mL of 0.1 M barium chloride and about 0.5 mg of phthalein purple R. Titrate with 0.1 M sodium edetate adding 50 mL of ethanol (96 per cent) R when the colour of the solution begins to change and continue the 1 mL of 0.1 M barium chloride is equivalent to 9.606 mg of SO4<\/sub>.<\/p>\n If intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of pyrogens, it complies with the test for pyrogens. Inject per kilogram of the rabbit’s mass 1 mL of a 10 mg\/mL solution of the substance to be examined in water for injections R.<\/p>\n Carry out the microbiological assay of antibiotics (2.7.2). Use kanamycin monosulfate CRS as the reference substance.<\/p>\n If the substance is sterile, store in a sterile, tamper-evident container.<\/p>\n","protected":false},"excerpt":{"rendered":" Kanamycin Sulphate (Kanamycin Monosulfate, Ph. Eur. monograph 0032) C18H38N4O15S,H2O\u00a0 \u00a0 \u00a0 601\u00a0 \u00a0 \u00a0 \u00a05965-95-7 Action and use Aminoglycoside antibacterial. DEFINITION 6-O-(3-Amino-3-deoxy-\u03b1-D-glucopyranosyl)-4-O-(6-amino-6-deoxy-\u03b1-D-glucopyranosyl)-2-deoxy-D-streptamine sulfate monohydrate. Antimicrobial substance produced by the growth of certain strains of Streptomyces kanamyceticus. Content Minimum 750 IU\/mg (dried substance). PRODUCTION It is produced by methods of manufacture designed to eliminate or minimise…<\/p>\n","protected":false},"author":2,"featured_media":16622,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-16371","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16371","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=16371"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16371\/revisions"}],"predecessor-version":[{"id":16377,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16371\/revisions\/16377"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/16622"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=16371"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=16371"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=16371"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
Content<\/h3>\n
PRODUCTION<\/h2>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Solubility<\/h3>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Solution S<\/h3>\n
pH (2.2.3)<\/h4>\n
Specific optical rotation (2.2.7)<\/h4>\n
Kanamycin B<\/h3>\n
Loss on drying (2.2.32)<\/h4>\n
Sulfated ash (2.4.14)<\/h4>\n
Sulfate<\/h3>\n
\ntitration until the violet-blue colour disappears.<\/p>\nPyrogens (2.6.8)<\/h3>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n