{"id":23864,"date":"2025-11-01T14:35:54","date_gmt":"2025-11-01T07:35:54","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=23864"},"modified":"2025-11-01T14:46:35","modified_gmt":"2025-11-01T07:46:35","slug":"magnesium-pidolate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/magnesium-pidolate\/","title":{"rendered":"Magnesium Pidolate"},"content":{"rendered":"<p>BP 2025 (Ph. Eur. 11.6 update)<\/p>\n<p>General Notices<\/p>\n<p>(Ph. Eur. monograph 1619)<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-23910\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Magnesium-Pidolate-3.jpg\" alt=\"\" width=\"1200\" height=\"650\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Magnesium-Pidolate-3.jpg 1200w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Magnesium-Pidolate-3-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Magnesium-Pidolate-3-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Magnesium-Pidolate-3-768x416.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/>C<sub>10<\/sub>H<sub>12<\/sub>MgN<sub>2<\/sub>O<sub>6<\/sub> 280.5 62003-27-4<\/p>\n<p>Ph Eur<\/p>\n<h2>DEFINITION<\/h2>\n<p>Magnesium bis[(2S)-5-oxopyrrolidine-2-carboxylate].<\/p>\n<h3>Content<\/h3>\n<p>8.49 per cent to 8.84 per cent of Mg (A<sub>r<\/sub> = 24.31) (anhydrous substance).<\/p>\n<h2>CHARACTERS<\/h2>\n<h3>Appearance<\/h3>\n<p>Amorphous, white or almost white powder, hygroscopic.<\/p>\n<h3>Solubility<\/h3>\n<p>Very soluble in water, soluble in methanol, practically insoluble in methylene chloride.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Thin-layer chromatography (2.2.27).<\/p>\n<p>Test solution Dissolve 60 mg of the substance to be examined in 2 mL of water R and dilute to 10 mL with methanol R.<\/p>\n<p>Reference solution Dissolve 55 mg of pidolic acid CRS in 2 mL of water R and dilute to 10 mL with methanol R.<\/p>\n<p>Plate TLC silica gel plate R.<\/p>\n<p>Mobile phase methanol R, glacial acetic acid R, methylene chloride R (15:20:65 V\/V\/V).<\/p>\n<p>Application 1 \u03bcL.<\/p>\n<p>Development Over 2\/3 of the plate.<\/p>\n<p>Drying At 100-105 \u00b0C for 15 min.<\/p>\n<p>Detection Spray with strong sodium hypochlorite solution R. Allow to stand for 10 min and spray abundantly with glacial acetic acid R. Allow to stand again for 10 min and dry at 100-105 \u00b0C for 2 min. Spray with potassium iodide and starch solution R until spots appear.<\/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. The chromatogram obtained with the test solution may show 2 faint secondary spots.<\/p>\n<p>B. To 0.15 mL of solution S (see Tests) add 1.8 mL of water R. The solution gives the reaction of magnesium (2.3.1).<\/p>\n<h2>TESTS<\/h2>\n<h3>Solution S<\/h3>\n<p>Dissolve 5.00 g in carbon dioxide-free water R prepared from distilled water R and dilute to 50.0 mL with the same solvent.<\/p>\n<h3>Appearance of solution<\/h3>\n<p>Solution S is clear (2.2.1) and not more intensely coloured than reference solution B<sub>8<\/sub> (2.2.2, Method I).<\/p>\n<h4>pH (2.2.3)<\/h4>\n<p>5.5 to 7.0 for solution S.<\/p>\n<h4>Specific optical rotation (2.2.7)<\/h4>\n<p>-26.5 to -23.3 (anhydrous substance), determined on solution S.<\/p>\n<h3>Impurity A<\/h3>\n<p>Thin-layer chromatography (2.2.27).<\/p>\n<p>Test solution Dissolve 0.250 g of the substance to be examined in 4 mL of water R and dilute to 50.0 mL with methanol R.<\/p>\n<p>Reference solution (a) Dissolve 60.0 mg of glutamic acid R in 50 mL of water R and dilute to 100.0 mL with methanol R. Dilute 1.0 mL of the solution to 20.0 mL with methanol R.<\/p>\n<div>Reference solution (b) Dissolve 10 mg of aspartic acid R and 10 mg of glutamic acid R in water R and dilute to 25 mL with the same solvent. Dilute 1 mL of the solution to 10 mL with water R.<\/div>\n<div>Plate TLC silica gel plate R.<\/div>\n<div>Mobile phase glacial acetic acid R, water R, butanol R (20:20:60 V\/V\/V).<\/div>\n<div>Application 5 \u03bcL.<\/div>\n<div>Development Over 2\/3 of the plate.<\/div>\n<div>Drying In air.<\/div>\n<div>Detection Spray with ninhydrin solution R and heat at 100-105 \u00b0C for 15 min.<\/div>\n<div>System suitability Reference solution (b):<\/div>\n<div>\u2014 the chromatogram shows 2 clearly separated spots.<\/div>\n<div>Limit:<\/div>\n<div>\u2014 impurity A: any spot due to impurity A is not more intense than the spot in the chromatogram obtained<\/div>\n<div>with reference solution (a) (0.6 per cent).<\/div>\n<h3>Related substances<\/h3>\n<div>Liquid chromatography (2.2.29).<\/div>\n<div>Test solution Dissolve 0.500 g of the substance to be examined in the mobile phase and dilute to 100.0 mL<\/div>\n<div>with the mobile phase.<\/div>\n<div>Reference solution (a) Dilute 1.0 mL of the test solution to 100.0 mL with the mobile phase.<\/div>\n<div>Reference solution (b) Dissolve 50.0 mg of pidolate impurity B CRS in the mobile phase and dilute to 100.0 mL with the mobile phase. Dilute 5.0 mL of the solution to 50.0 mL with the mobile phase.<\/div>\n<div>Reference solution (c) Dilute 10.0 mL of reference solution (b) to 100.0 mL with the mobile phase.<\/div>\n<div>Reference solution (d) Dilute 1.0 mL of nitrate standard solution (100 ppm NO3) R to 100.0 mL with the mobile phase.<\/div>\n<div>Reference solution (e) Dilute 6.0 mL of reference solution (a) to 10.0 mL with reference solution (b).<\/div>\n<div>Column:<\/div>\n<div>\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/div>\n<div>\u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm).<\/div>\n<div>Mobile phase Dissolve 1.56 g of sodium dihydrogen phosphate R in 1000 mL of water for<\/div>\n<div>chromatography R and adjust to pH 2.5 with a 10 per cent V\/V solution of phosphoric acid R.<\/div>\n<div>Flow rate 1.5 mL\/min.<\/div>\n<div>Detection Spectrophotometer at 210 nm.<\/div>\n<div>Injection 10 \u03bcL of the test solution and reference solutions (b), (c), (d) and (e).<\/div>\n<div>Run time 4 times the retention time of pidolic acid.<\/div>\n<div>Retention times Pidolic acid = about 4.5 min; impurity B = about 7.5 min.<\/div>\n<div>System suitability Reference solution (e):<\/div>\n<div>\u2014 resolution: minimum 10 between the peaks due to pidolic acid and impurity B.<\/div>\n<p>Limits:<\/p>\n<p>\u2014 impurity B: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent);<\/p>\n<p>\u2014 unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (c) (0.10 per cent);<\/p>\n<p>\u2014 total of other impurities: not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent);<\/p>\n<p>\u2014 disregard limit:5 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.05 per cent); disregard any peak due to the nitrate ion (NO<sub>3<\/sub><sup>&#8211;<\/sup>).<\/p>\n<h3>Chlorides (2.4.4)<\/h3>\n<p>Maximum 500 ppm.<\/p>\n<p>Dilute 1.0 mL of solution S to 15.0 mL with water R.<\/p>\n<h3>Nitrates<\/h3>\n<p>Examine the chromatogram obtained with the test solution in the test for related substances.<\/p>\n<p>Limit:<\/p>\n<p>\u2014 nitrates: not more than the area of the principal peak in the chromatogram obtained with reference solution (d) (200 ppm).<\/p>\n<h2>Sulfates (2.4.13)<\/h2>\n<p>Maximum 0.1 per cent.<\/p>\n<p>Dilute 1.5 mL of solution S to 15.0 mL with distilled water R.<\/p>\n<h2>Iron (2.4.9)<\/h2>\n<p>Maximum 200 ppm.<\/p>\n<p>Dilute 0.5 mL of solution S to 10 mL with water R.<\/p>\n<h4>Water (2.5.12)<\/h4>\n<p>Maximum 8.0 per cent, determined on 0.200 g.<\/p>\n<h2>ASSAY<\/h2>\n<p>Dissolve 0.300 g in 50 mL of waterR. Carry out the complexometric titration of magnesium (2.5.11).<\/p>\n<p>1 mL of 0.1 M sodium edetate is equivalent to 2.431 mg of Mg.<\/p>\n<h2>STORAGE<\/h2>\n<p>In an airtight container.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>Specified impurities A, B.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-23897\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Magnesium-Pidolate-1.jpg\" alt=\"Magnesium Pidolate\" width=\"1200\" height=\"650\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Magnesium-Pidolate-1.jpg 1200w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Magnesium-Pidolate-1-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Magnesium-Pidolate-1-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Magnesium-Pidolate-1-768x416.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><\/p>\n<p>A. (2S)-2-aminopentanedioic acid (glutamic acid),<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-23909\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Magnesium-Pidolate-2.jpg\" alt=\"\" width=\"1200\" height=\"650\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Magnesium-Pidolate-2.jpg 1200w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Magnesium-Pidolate-2-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Magnesium-Pidolate-2-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Magnesium-Pidolate-2-768x416.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><\/p>\n<p>B. (2S)-2-[(2S)-5-oxopyrrolidine-2-carboxamido]pentanedioic acid.<\/p>\n<p>Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":"<p>BP 2025 (Ph. Eur. 11.6 update) General Notices (Ph. Eur. monograph 1619) C10H12MgN2O6 280.5 62003-27-4 Ph Eur DEFINITION Magnesium bis[(2S)-5-oxopyrrolidine-2-carboxylate]. Content 8.49 per cent to 8.84 per cent of Mg (Ar = 24.31) (anhydrous substance). CHARACTERS Appearance Amorphous, white or almost white powder, hygroscopic. Solubility Very soluble in water, soluble in methanol, practically insoluble in&#8230;<\/p>\n","protected":false},"author":5,"featured_media":23912,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-23864","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\/23864","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\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=23864"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23864\/revisions"}],"predecessor-version":[{"id":23924,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23864\/revisions\/23924"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/23912"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=23864"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=23864"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=23864"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}