(Ph. Eur. monograph 0979)<\/p>\n
C12<\/sub>H22<\/sub>CaO14<\/sub>,H2<\/sub>O\u00a0 \u00a0 \u00a0 448.4\u00a0 \u00a0 \u00a0 18016-24-5<\/p>\n Action and use<\/strong><\/p>\n Used in treatment of calcium deficiency.<\/p>\n Preparation<\/strong><\/p>\n Calcium Gluconate Injection<\/p>\n Calcium bis[(2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoate] monohydrate (calcium di(D-gluconate) monohydrate).<\/p>\n 99.0 per cent to 101.0 per cent of C12H22CaO14,H2O.<\/p>\n White or almost white, crystalline or granular powder.<\/p>\n Sparingly soluble in water, freely soluble in boiling water.<\/p>\n A. Thin-layer chromatography (2.2.27).<\/p>\n Test solution: Dissolve 20 mg of the substance to be examined in 1 mL of water R, heating if necessary in a water-bath at 60 \u00b0C.<\/p>\n Reference solution: Dissolve 20 mg of calcium gluconate CRS in 1 mL of water R, heating if necessary in a water-bath at 60 \u00b0C.<\/p>\n Plate: TLC silica gel plate R (5-40 \u03bcm) [or TLC silica gel plate R (2-10 \u03bcm)].<\/p>\n Mobile phase: concentrated ammonia R, ethyl acetate R, water R, ethanol (96 per cent) R (10:10:30:50 V\/V\/V\/V).<\/p>\n Application: 1 \u03bcL.<\/p>\n Development: Over 2\/3 of the plate.<\/p>\n Drying: At 100 \u00b0C for 20 min; allow to cool.<\/p>\n Detection: Spray with a solution containing 10 g\/L of cerium sulfate R and 25 g\/L of ammonium molybdate R in dilute sulfuric acid R and heat at 105 \u00b0C for about 10 min.<\/p>\n Results: After 5 min, 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 B. About 20 mg gives reaction (b) of calcium (2.3.1).<\/p>\n To 10.0 g add 90 mL of boiling distilled water R and boil with stirring, for not more than 10 s, until completely dissolved, then dilute to 100.0 mL with the same solvent.<\/p>\n At 60 \u00b0C, solution S is not more intensely coloured than reference solution B7<\/sub> (2.2.2, Method II). After cooling to 20 \u00b0C, it is not more opalescent than reference suspension II (2.2.1).<\/p>\n 6.4 to 8.3.<\/p>\n Dissolve 1.0 g in 20 mL of carbon dioxide-free water R, heating on a water-bath.<\/p>\n Introduce 0.5 g into a porcelain dish previously rinsed with sulfuric acid R and placed in a bath of iced water. Add 2 mL of cooled sulfuric acid R and mix. No yellow or brown colour develops. Add 1 mL of chromotrope II B solution R. A violet colour develops and does not become dark blue. The solution is not more intensely coloured than that of a mixture of 1 mL of chromotrope II B solution R and 2 mL of cooled sulfuric acid R.<\/p>\n Liquid chromatography (2.2.29).<\/p>\n Solvent mixture: Dilute 1 mL of hydrochloric acid R to 1200 mL with water for chromatography R.<\/p>\n Test solution: Dissolve 0.200 g of the substance to be examined in the solvent mixture using sonication and dilute to 10.0 mL with the solvent mixture.<\/p>\n Reference solution (a): Dilute 2.0 mL of a 0.152 g\/L solution of sodium oxalate R to 100.0 mL with the solvent mixture.<\/p>\n Reference solution (b): Mix 2 mL of a 0.152 g\/L solution of sodium oxalate R, 20 mL of sulfate standard solution (10 ppm SO4<\/sub>) R and 50 mL of water for chromatography R, and dilute to 100 mL with water for chromatography R.<\/p>\n Precolumn:<\/p>\n \u2014 size: l = 50 mm, \u00d8 = 4 mm;<\/p>\n \u2014 stationary phase: strongly basic anion-exchange resin for chromatography R2 (13 \u03bcm).<\/p>\n Column:<\/p>\n \u2014 size: l = 0.25 m, \u00d8 = 4 mm;<\/p>\n \u2014 stationary phase: strongly basic anion-exchange resin for chromatography R2 (13 \u03bcm).<\/p>\n Mobile phase: Dissolve 0.143 g of sodium hydrogen carbonate R and 0.191 g of anhydrous sodium carbonate R in water for chromatography R and dilute to 1000 mL with the same solvent.<\/p>\n Flow rate: 2 mL\/min.<\/p>\n Detection: Conductivity detector equipped with a suitable ion suppressor.<\/p>\n Injection: 50 \u03bcL.<\/p>\n Run time: 1.5 times the retention time of oxalate.<\/p>\n Retention time: Sulfate = about 8.1 min; oxalate = about 10.6 min.<\/p>\n System suitability: Reference solution (b):<\/p>\n \u2014 repeatability: maximum relative standard deviation of 2.0 per cent for the area of the peak due to oxalate, determined on 5 injections;<\/p>\n \u2014 resolution: minimum 4.0 between the peaks due to sulfate and oxalate.<\/p>\n Calculation of content:<\/p>\n \u2014 for oxalates, use the concentration of sodium oxalate in reference solution (a).<\/p>\n Limit:<\/p>\n \u2014 oxalates: maximum 100 ppm.<\/p>\n Dissolve 0.5 g in a mixture of 2 mL of hydrochloric acid R1 and 10 mL of water R. Boil for 5 min, allow to cool, add 10 mL of sodium carbonate solution R and allow to stand for 10 min. Dilute to 25 mL with water R and filter. To 5 mL of the filtrate add 2 mL of cupri-tartaric solution R and boil for 1 min. Allow to stand for 2 min. No red precipitate is formed.<\/p>\n Maximum 50 ppm.<\/p>\n To 10 mL of previously filtered solution S add 5 mL of water R.<\/p>\n Maximum 100 ppm.<\/p>\n Dilute 1 mL of solution S to 100 mL with water R.<\/p>\n Maximum 50 ppm, determined on previously filtered solution S.<\/p>\n Prepare the standard using a mixture of 7.5 mL of sulfate standard solution (10 ppm SO4<\/sub>) R and 7.5 mL of distilled water R.<\/p>\n Maximum 5 ppm.<\/p>\n Atomic absorption spectrometry (2.2.23, Method I).<\/p>\n Test solution: Introduce 2.0 g into a 100 mL polytetrafluoroethylene beaker and add 5 mL of nitric acid R. Boil, evaporating almost to dryness. Add 1 mL of strong hydrogen peroxide solution R and evaporate again almost to dryness. Repeat the hydrogen peroxide treatment until a clear solution is obtained. Using 2 mL of nitric acid R, transfer the solution into a 25 mL volumetric flask. Dilute to 25.0 mL with dilute hydrochloric acid R. In the same manner, prepare a compensation solution using 0.65 g of calcium chloride R1 instead of the substance to be examined.<\/p>\n Reference solutions: Prepare the reference solutions from iron standard solution (20 ppm Fe) R, diluting with dilute hydrochloric acid R.<\/p>\n Source: Iron hollow-cathode lamp.<\/p>\n Wavelength: 248.3 nm.<\/p>\n Atomisation device: Air-acetylene flame.<\/p>\n Carry out a basic correction using a deuterium lamp.<\/p>\n Maximum 0.4 per cent.<\/p>\n To 0.50 g add a mixture of 1.0 mL of dilute acetic acid R and 10.0 mL of water R and rapidly boil, whilst shaking, until completely dissolved. To the boiling solution add 5.0 mL of ammonium oxalate solution R and allow to stand for at least 6 h. Filter through a sintered-glass filter (1.6) (2.1.2) into a porcelain crucible. Carefully evaporate the filtrate to dryness Less than 167 IU\/g.<\/p>\n TAMC: acceptance criterion 10 CFU\/g (2.6.12).<\/p>\n Dissolve 0.350 g in 20 mL of hot water R, allow to cool and dilute to 300 mL with water R. Carry out the complexometric titration of calcium (2.5.11). Use 50 mg of calconecarboxylic acid triturate R.<\/p>\n 1 mL of 0.1 M sodium edetate is equivalent to 44.84 mg of C12<\/sub>H22<\/sub>CaO14<\/sub>,H2<\/sub>O.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 0979) C12H22CaO14,H2O\u00a0 \u00a0 \u00a0 448.4\u00a0 \u00a0 \u00a0 18016-24-5 Action and use Used in treatment of calcium deficiency. Preparation Calcium Gluconate Injection DEFINITION Calcium bis[(2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoate] monohydrate (calcium di(D-gluconate) monohydrate). Content 99.0 per cent to 101.0 per cent of C12H22CaO14,H2O. CHARACTERS Appearance White or almost white, crystalline or granular powder. Solubility Sparingly soluble in…<\/p>\n","protected":false},"author":2,"featured_media":4550,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-4539","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\/4539","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=4539"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4539\/revisions"}],"predecessor-version":[{"id":5306,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4539\/revisions\/5306"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/4550"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=4539"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=4539"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=4539"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
Content<\/h3>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Solubility<\/h3>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Solution S<\/h3>\n
Appearance of solution<\/h3>\n
pH (2.2.3)<\/h4>\n
Organic impurities and boric acid<\/h3>\n
Oxalates<\/h3>\n
Sucrose and reducing sugars<\/h3>\n
Chlorides (2.4.4)<\/h3>\n
Phosphates (2.4.11)<\/h3>\n
Sulfates (2.4.13)<\/h3>\n
Iron<\/h3>\n
Magnesium and alkali metals<\/h3>\n
\nand ignite. The residue weighs not more than 2 mg.<\/p>\nBacterial endotoxins (2.6.14)<\/h4>\n
Microbial contamination<\/h3>\n
ASSAY<\/h2>\n