{"id":28236,"date":"2025-11-08T10:41:11","date_gmt":"2025-11-08T03:41:11","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=28236"},"modified":"2025-11-08T10:41:11","modified_gmt":"2025-11-08T03:41:11","slug":"prednicarbate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/prednicarbate\/","title":{"rendered":"Prednicarbate"},"content":{"rendered":"<p><em>(Ph. Eur. monograph 1467)<\/em><\/p>\n<p>C<sub>27<\/sub>H<sub>36<\/sub>O<sub>8<\/sub> 488.6 73771-04-7<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Glucocorticoid.<\/p>\n<h2>DEFINITION<\/h2>\n<p>11\u03b2-Hydroxy-3,20-dioxopregna-1,4-diene-17,21-diyl 17-(ethyl carbonate) 21-propanoate.<\/p>\n<h3>Content<\/h3>\n<p>97.0 per cent to 102.0 per cent (dried substance).<\/p>\n<h2>CHARACTERS<\/h2>\n<h3>Appearance<\/h3>\n<p>White or almost white, crystalline powder.<\/p>\n<h3>Solubility<\/h3>\n<p>Practically insoluble in water, freely soluble in acetone and in ethanol (96 per cent), sparingly soluble in propylene glycol.<\/p>\n<p>It shows polymorphism (5.9).<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>First identification: A.<\/p>\n<p>Second identification: B.<\/p>\n<p>A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n<p>Comparison: prednicarbate CRS.<\/p>\n<p>If the spectra obtained in the solid state show differences, dissolve the substance to be examined and the reference substance separately in the minimum volume of ethanol (96 per cent) R, evaporate to dryness on a water-bath and record new spectra using the residues.<\/p>\n<p>B. Thin-layer chromatography (2.2.27).<\/p>\n<p>Test solution: Dissolve 10 mg of the substance to be examined in the mobile phase and dilute to 10.0 mL with the mobile phase.<\/p>\n<p>Reference solution: Dissolve 10 mg of prednicarbate CRS in the mobile phase and dilute to 10.0 mL with the mobile phase.<\/p>\n<p>Plate: TLC silica gel F254 plate R.<\/p>\n<p>Mobile phase: methanol R, methylene chloride R (10:90 V\/V).<\/p>\n<p>Application: 5 \u03bcL; the volume may be adapted based on the type of plate used.<\/p>\n<p>Development: Over 3\/4 of the plate.<\/p>\n<p>Drying: In air.<\/p>\n<p>Detection: Spray with a solution prepared as follows: dissolve 0.25 g of 2,4-dihydroxybenzaldehyde R in glacial acetic acid R, dilute to 50 mL with the same solvent and add a mixture of 12.5 mL of sulfuric acid R and 37.5 mL of glacial acetic acid R; heat the plate at 90 \u00b0C for 35 min or until the spots appear, allow to cool and examine in daylight and in ultraviolet light at 365 nm.<\/p>\n<p>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 the reference solution.<\/p>\n<h2>TESTS<\/h2>\n<h3>Specific optical rotation (2.2.7)<\/h3>\n<p>+ 60 to + 66 (dried substance).<\/p>\n<p>Dissolve 0.250 g in ethanol (96 per cent) R and dilute to 25.0 mL with the same solvent.<\/p>\n<h3>Related substances<\/h3>\n<p>Liquid chromatography (2.2.29). Prepare the solutions immediately before use.<\/p>\n<p>Test solution: Dissolve 30.0 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 3 mg of prednicarbate for system suitability A CRS (containing impurities B, C, D, E and F) in the mobile phase and dilute to 5 mL with the mobile phase.<\/p>\n<p>Reference solution (b): Dissolve 3 mg of prednicarbate for peak identification CRS (containing impurity G) in the mobile phase and dilute to 5 mL with the mobile phase.<\/p>\n<p>Reference solution (c): 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 (d): Dissolve 30.0 mg of prednicarbate CRS in the mobile phase and dilute to 50.0 mL with the mobile phase.<\/p>\n<p>Column:<\/p>\n<p>\u2014 size: l = 0.125 m, \u00d8 = 4 mm;<\/p>\n<p>\u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm).<\/p>\n<p>Mobile phase: acetonitrile for chromatography R, water for chromatography R (50:60 V\/V).<\/p>\n<p>Flow rate: 0.7 mL\/min.<\/p>\n<p>Detection: Spectrophotometer at 243 nm.<\/p>\n<p>Injection: 20 \u03bcL of the test solution and reference solutions (a), (b) and (c).<\/p>\n<p>Run time: 2.6 times the retention time of prednicarbate.<\/p>\n<p>Identification of impurities: Use the chromatogram supplied with prednicarbate for system suitability A CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities B, C, D, E and F; use the chromatogram supplied with prednicarbate for peak identification CRS and the chromatogram obtained with reference solution (b) to identify the peak due to impurity G.<\/p>\n<p>Relative retention: With reference to prednicarbate (retention time = about 20 min): impurity B = about 0.25; impurity C = about 0.35; impurity D = about 0.39; impurity E = about 0.6; impurity F = about 1.2; impurity G = about 2.4.<\/p>\n<p>System suitability: Reference solution (a):<\/p>\n<p>\u2014 resolution: minimum 3.0 between the peaks due to prednicarbate and impurity F; minimum 1.5 between the peaks due to impurities C and D.<\/p>\n<p>Calculation of percentage contents:<\/p>\n<p>\u2014 for each impurity, use the concentration of prednicarbate in reference solution (c).<\/p>\n<p>Limits:<\/p>\n<p>\u2014 impurity F: maximum 0.8 per cent;<\/p>\n<p>\u2014 impurity C: maximum 0.5 per cent;<\/p>\n<p>\u2014 impurity E: maximum 0.3 per cent;<\/p>\n<p>\u2014 impurities B, D: for each impurity, maximum 0.2 per cent;<\/p>\n<p>\u2014 impurity G: 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 2.0 per cent;<\/p>\n<p>\u2014 reporting threshold: 0.05 per cent.<\/p>\n<h3>Loss on drying (2.2.32)<\/h3>\n<p>Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<\/p>\n<h2>ASSAY<\/h2>\n<p>Liquid chromatography (2.2.29) as described in the test for related substances with the following modification.<\/p>\n<p>Injection: Test solution and reference solution (d).<\/p>\n<p>Calculate the percentage content of C<sub>27<\/sub>H<sub>36<\/sub>O<sub>8<\/sub> taking into account the assigned content of prednicarbate CRS.<\/p>\n<h2>STORAGE<\/h2>\n<p>Protected from light.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>Specified impurities B, C, D, E, F, G.<\/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) A.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-28246\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-36-300x163.jpg\" alt=\"Prednicarbate \" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-36-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-36-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-36-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-36.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>A. 11\u03b2,17,21-trihydroxypregna-1,4-diene-3,20-dione (prednisolone),<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-28247\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-35-300x163.jpg\" alt=\"Prednicarbate \" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-35-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-35-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-35-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-35.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>B. ethyl 11\u03b2,21-dihydroxy-3,20-dioxopregna-1,4-dien-17-yl carbonate (prednisolone 17-ethylcarbonate),<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-28248\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-33-300x163.jpg\" alt=\"Prednicarbate \" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-33-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-33-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-33-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-33.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>C. 11\u03b2,17-dihydroxy-3,20-dioxopregna-1,4-dien-21-yl propanoate (prednisolone 21-propanoate),<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-28249\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/5-32-300x163.jpg\" alt=\"Prednicarbate \" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/5-32-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/5-32-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/5-32-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/5-32.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>D. ethyl 11\u03b2,17-dihydroxy-3,20-dioxopregna-1,4-dien-21-yl carbonate (prednisolone 21-ethylcarbonate),<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-28250\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/6-28-300x163.jpg\" alt=\"Prednicarbate \" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/6-28-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/6-28-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/6-28-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/6-28.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>E. 11\u03b2-hydroxy-3,20-dioxopregna-1,4-diene-17,21-diyl 21-acetate 17-(ethyl carbonate) (prednisolone 21-acetate 17-ethylcarbonate),<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-28251\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/7-25-300x163.jpg\" alt=\"Prednicarbate \" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/7-25-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/7-25-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/7-25-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/7-25.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>F. 11\u03b2-hydroxy-3,20-dioxopregn-4-ene-17,21-diyl 17-(ethyl carbonate) 21-propanoate (1,2-dihydroprednicarbate),<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-28252\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/8-19-300x163.jpg\" alt=\"Prednicarbate \" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/8-19-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/8-19-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/8-19-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/8-19.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>G. 3,20-dioxo-11\u03b2-pregna-1,4-diene-11,17,21-triyl 17-(ethyl carbonate) 11,21-dipropanoate (prednicarbate 11-propanoate).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>(Ph. Eur. monograph 1467) C27H36O8 488.6 73771-04-7 Action and use Glucocorticoid. DEFINITION 11\u03b2-Hydroxy-3,20-dioxopregna-1,4-diene-17,21-diyl 17-(ethyl carbonate) 21-propanoate. Content 97.0 per cent to 102.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Practically insoluble in water, freely soluble in acetone and in ethanol (96 per cent), sparingly soluble in propylene glycol. It&#8230;<\/p>\n","protected":false},"author":4,"featured_media":28245,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-28236","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\/28236","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=28236"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28236\/revisions"}],"predecessor-version":[{"id":28255,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28236\/revisions\/28255"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/28245"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=28236"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=28236"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=28236"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}