{"id":16859,"date":"2025-10-21T12:06:25","date_gmt":"2025-10-21T05:06:25","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=16859"},"modified":"2025-10-21T12:06:25","modified_gmt":"2025-10-21T05:06:25","slug":"levofloxacin-hemihydrate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/levofloxacin-hemihydrate\/","title":{"rendered":"Levofloxacin Hemihydrate"},"content":{"rendered":"<p>(Ph. Eur. monograph 2598)<\/p>\n<p>C<sub>18<\/sub>H<sub>20<\/sub>FN<sub>3<\/sub>O<sub>4<\/sub>,1\u20442H<sub>2<\/sub>O\u00a0 \u00a0 \u00a0 370.4\u00a0 \u00a0 \u00a0 \u00a0 138199-71-0<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Fluoroquinolone antibacterial.<\/p>\n<p><strong>Preparations<\/strong><\/p>\n<p>Levofloxacin Eye Drops<\/p>\n<p>Levofloxacin Infusion<\/p>\n<p>Levofloxacin Tablets<\/p>\n<h2>DEFINITION<\/h2>\n<p>(3S)-9-Fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine- 6-carboxylic acid hemihydrate.<\/p>\n<h3>Content<\/h3>\n<p>98.0 per cent to 101.0 per cent (anhydrous substance).<\/p>\n<h2>CHARACTERS<\/h2>\n<h3>Appearance<\/h3>\n<p>Light yellowish-white or light yellow, crystalline powder.<\/p>\n<h3>Solubility<\/h3>\n<p>Sparingly soluble in water, freely soluble in acetic acid, sparingly soluble in methanol, slightly soluble in anhydrous ethanol.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n<p>Comparison: levofloxacin hemihydrate CRS.<\/p>\n<p>B. Examine the chromatograms obtained in the test for related substances.<\/p>\n<p>Results: The principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the chromatogram obtained with reference solution (b).<\/p>\n<h2>TESTS<\/h2>\n<h3>Appearance of solution<\/h3>\n<p>The solution is clear (2.2.1) and not more intensely coloured than reference solution GY<sub>3<\/sub> (2.2.2, Method II).<\/p>\n<p>Dissolve 0.100 g in water R and dilute to 10 mL with the same solvent.<\/p>\n<h3>Related substances<\/h3>\n<p>Liquid chromatography (2.2.29).<\/p>\n<p>Buffer solution: Solution containing 1.25 g\/L of copper sulfate pentahydrate R, 1.3 g\/L of isoleucine R and 8.5 g\/L of ammonium acetate R in water for chromatography R.<\/p>\n<p>Test solution: Dissolve 50.0 mg of the substance to be examined in the mobile phase and dilute to 50.0 mL with the mobile phase.<\/p>\n<p>Reference solution (a): Dilute 1.0 mL of the test solution to 100.0 mL with the mobile phase. Dilute 1.0 mL of this solution to 10.0 mL with the mobile phase.<\/p>\n<p>Reference solution (b): Dissolve the contents of a vial of levofloxacin for system suitability CRS (containing impurities A, B and G) in 1 mL of the mobile phase.<\/p>\n<p>Column:<\/p>\n<p>\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n<p>\u2014 stationary phase: base-deactivated end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm);<\/p>\n<p>\u2014 temperature: 45 \u00b0C.<\/p>\n<p>Mobile phase: methanol R, buffer solution (30:70 V\/V).<\/p>\n<p>Flow rate: 0.8 mL\/min.<\/p>\n<p>Detection: Spectrophotometer at 360 nm.<\/p>\n<p>Injection: 25 \u03bcL.<\/p>\n<p>Run time: 3 times the retention time of levofloxacin.<\/p>\n<p>Identification of impurities: Use the chromatogram supplied with levofloxacin for system suitability CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A, B and G.<\/p>\n<p>Relative retention: With reference to levofloxacin (retention time = about 20 min): impurity B = about 0.50; impurity G = about 0.56; impurity A = about 1.22.<\/p>\n<p>System suitability: Reference solution (b):<\/p>\n<p>\u2014 resolution: minimum 1.5 between the peaks due to impurities B and G.<\/p>\n<p>Calculation of percentage contents:<\/p>\n<p>\u2014 correction factor: multiply the peak area of impurity B by 1.3;<\/p>\n<p>\u2014 for each impurity, use the concentration of levofloxacin hemihydrate in reference solution (a).<\/p>\n<p>Limits:<\/p>\n<p>\u2014 impurity A: maximum 0.5 per cent;<\/p>\n<p>\u2014 impurity B: maximum 0.15 per cent;<\/p>\n<p>\u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n<p>\u2014 total: maximum 0.6 per cent;<\/p>\n<p>\u2014 reporting threshold: 0.05 per cent.<\/p>\n<h3>Impurity F<\/h3>\n<p>Liquid chromatography (2.2.29) as described in the test for related substances with the following modifications.<\/p>\n<p>Test solution: Dissolve 50.0 mg of the substance to be examined in the mobile phase and dilute to 50.0 mL with the mobile phase.<\/p>\n<p>Reference solution (a): Dissolve 5.0 mg of levofloxacin impurity F CRS in the mobile phase and dilute to 100.0 mL with the mobile phase.<\/p>\n<p>Reference solution (b): Dilute 1.0 mL of reference solution (a) to 25.0 mL with the mobile phase.<\/p>\n<p>Reference solution (c): Dilute 4 mL of reference solution (a) to 10 mL with the mobile phase. Dilute 1 mL of this solution to 10 mL with the test solution.<\/p>\n<p>Mobile phase: methanol R, buffer solution (50:50 V\/V).<\/p>\n<p>Detection: Spectrophotometer at 320 nm.<\/p>\n<p>Injection: Test solution and reference solutions (b) and (c).<\/p>\n<p>Identification of impurities: Use the chromatogram obtained with reference solution (b) to identify the peak due to impurity F.<\/p>\n<p>Relative retention: With reference to levofloxacin (retention time = about 6 min): impurity F = about 1.8.<\/p>\n<p>System suitability: Reference solution (c):<\/p>\n<p>\u2014 resolution: minimum 5.0 between the peaks due to levofloxacin and impurity F.<\/p>\n<p>Calculation of percentage content:<\/p>\n<p>\u2014 for impurity F, use the concentration of impurity F in reference solution (b).<\/p>\n<p>Limit:<\/p>\n<p>\u2014 impurity F: maximum 0.2 per cent.<\/p>\n<h4>Water (2.5.12)<\/h4>\n<p>2.0 per cent to 3.0 per cent, determined on 0.500 g using a mixture of equal volumes of formamide R and methanol R as solvent.<\/p>\n<h4>Sulfated ash (2.4.14)<\/h4>\n<p>Maximum 0.1 per cent, determined on 1.0 g in a platinum crucible.<\/p>\n<h2>ASSAY<\/h2>\n<p>Dissolve 0.300 g in 100 mL of anhydrous acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n<p>1 mL of 0.1 M perchloric acid is equivalent to 36.14 mg of C<sub>18<\/sub>H<sub>20<\/sub>FN<sub>3<\/sub>O<sub>4<\/sub>.<\/p>\n<h2>STORAGE<\/h2>\n<p>Protected from light.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>Specified impurities A, B, F.<\/p>\n<p>Other detectable impurities (the following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph. They are limited by the general acceptance criterion for other\/unspecified impurities and\/or by the general monograph Substances for pharmaceutical use (2034). It is therefore not necessary to identify these impurities for demonstration of compliance. See also 5.10. Control of impurities in substances for pharmaceutical use) C, D, E, G, H, I.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-16863\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-A-300x163.jpg\" alt=\"Levofloxacin Hemihydrate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-A-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-A-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-A-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-A.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>A. (3R)-9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de] [1,4]benzoxazine-6-carboxylic acid (enantiomer of levofloxacin),<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-16864\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-B-300x163.jpg\" alt=\"Levofloxacin Hemihydrate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-B-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-B-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-B-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-B.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>B. (3S)-9-fluoro-3-methyl-7-oxo-10-(piperazin-1-yl)-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-16865\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-C-300x163.jpg\" alt=\"Levofloxacin Hemihydrate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-C-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-C-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-C-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-C.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>C. 4-[(3S)-6-carboxy-9-fluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazin-10-yl]-1-methylpiperazine 1-oxide,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-16866\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-D-300x163.jpg\" alt=\"Levofloxacin Hemihydrate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-D-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-D-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-D-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-D.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>D. (3S)-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-16867\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-E-300x163.jpg\" alt=\"Levofloxacin Hemihydrate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-E-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-E-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-E-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-E.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>E. (3S)-9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazin-7-one,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-16868\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-F-300x163.jpg\" alt=\"Levofloxacin Hemihydrate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-F-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-F-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-F-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-F.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>F. (3S)-9,10-difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-16869\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-G-300x163.jpg\" alt=\"Levofloxacin Hemihydrate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-G-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-G-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-G-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-G.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>G. (3S)-9-fluoro-3-methyl-10-[[2-(methylamino)ethyl]amino]-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de] [1,4]benzoxazine-6-carboxylic acid,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-16870\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-H-300x163.jpg\" alt=\"Levofloxacin Hemihydrate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-H-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-H-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-H-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-H.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>H. ethyl (3S)-9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de] [1,4]benzoxazine-6-carboxylate,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-16871\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-I-300x163.jpg\" alt=\"Levofloxacin Hemihydrate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-I-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-I-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-I-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Hemihydrate-I.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>I. (3S)-10-fluoro-3-methyl-9-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de] [1,4]benzoxazine-6-carboxylic acid.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>(Ph. Eur. monograph 2598) C18H20FN3O4,1\u20442H2O\u00a0 \u00a0 \u00a0 370.4\u00a0 \u00a0 \u00a0 \u00a0 138199-71-0 Action and use Fluoroquinolone antibacterial. Preparations Levofloxacin Eye Drops Levofloxacin Infusion Levofloxacin Tablets DEFINITION (3S)-9-Fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine- 6-carboxylic acid hemihydrate. Content 98.0 per cent to 101.0 per cent (anhydrous substance). CHARACTERS Appearance Light yellowish-white or light yellow, crystalline powder. Solubility Sparingly soluble in water, freely&#8230;<\/p>\n","protected":false},"author":2,"featured_media":16872,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-16859","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\/16859","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=16859"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16859\/revisions"}],"predecessor-version":[{"id":16875,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16859\/revisions\/16875"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/16872"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=16859"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=16859"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=16859"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}