{"id":14687,"date":"2025-10-15T16:12:17","date_gmt":"2025-10-15T09:12:17","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=14687"},"modified":"2025-10-15T16:12:17","modified_gmt":"2025-10-15T09:12:17","slug":"ferrous-gluconate-hydrate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/ferrous-gluconate-hydrate\/","title":{"rendered":"Ferrous Gluconate Hydrate"},"content":{"rendered":"

(Ph. Eur. monograph 0493)<\/em><\/p>\n

C12<\/sub>H22<\/sub>FeO14<\/sub>,xH2O 446.1 (anhydrous substance)<\/p>\n

Action and use<\/strong><\/p>\n

Used in prevention and treatment of iron deficiency.<\/p>\n

Preparation<\/strong><\/p>\n

Ferrous Gluconate Tablets<\/p>\n

DEFINITION<\/h2>\n

Iron(II) bis[(2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoate] (iron(II) di(D-gluconate)) hydrate.<\/p>\n

Content<\/h3>\n

11.8 per cent to 12.5 per cent of iron(II) (dried substance).<\/p>\n

It contains a variable quantity of water.<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

Greenish-yellow or grey powder or granules.<\/p>\n

Solubility<\/h3>\n

Freely but slowly soluble in water giving a greenish-brown solution, more readily soluble in hot water, practically insoluble in ethanol (96 per cent).<\/p>\n

IDENTIFICATION<\/h2>\n

A. Thin-layer chromatography (2.2.27).<\/p>\n

Test solution: Dissolve 20 mg of the substance to be examined in 2 mL of water R, heating if necessary in a water-bath at 60 \u00b0C.<\/p>\n

Reference solution: Dissolve 20 mg of ferrous gluconate CRS in 2 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 105 \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. 1 mL of solution S (see Tests) gives reaction (a) of iron (2.3.1).<\/p>\n

TESTS<\/h2>\n

Solution S<\/h3>\n

Dissolve 2.0 g in carbon dioxide-free water R prepared from distilled water R and heated to about 60 \u00b0C, allow to cool and dilute to 20 mL with carbon dioxide-free water R prepared from distilled water R.<\/p>\n

Appearance of solution<\/h3>\n

The solution is clear (2.2.1).<\/p>\n

Dilute 2 mL of solution S to 10 mL with water R. Examine the solution against the light.<\/p>\n

pH (2.2.3)<\/h3>\n

4.0 to 5.5 for solution S, measured 3-4 h after preparation.<\/p>\n

Sucrose and reducing sugars<\/h3>\n

Dissolve 0.5 g in 10 mL of warm water R and add 1 mL of dilute ammonia R1. Pass hydrogen sulfide R through the solution and allow to stand for 30 min. Filter and wash the precipitate with 2 quantities, each of 5 mL, of water R. Acidify the combined filtrate and washings to blue litmus paper R with dilute hydrochloric acid R and add 2 mL in excess. Boil until the vapour no longer darkens lead acetate paper R and continue boiling, if necessary, until the volume is reduced to about 10 mL. Cool, add 15 mL of sodium carbonate solution R, allow to stand for 5 min and filter. Dilute the filtrate to 100 mL with
\nwater R. To 5 mL of this solution add 2 mL of cupri-tartaric solution R and boil for 1 min. Allow to stand for 1 min. No red precipitate is formed.<\/p>\n

Chlorides (2.4.4)<\/h3>\n

Maximum 0.06 per cent.<\/p>\n

Dilute 0.8 mL of solution S to 15 mL with water R.<\/p>\n

Oxalates<\/h3>\n

Dissolve 5.0 g in a mixture of 10 mL of dilute sulfuric acid R and 40 mL of water R. Shake the solution with 50 mL of ether R for 5 min. Separate the aqueous layer and shake it with 20 mL of ether R for 5 min. Combine the ether layers, evaporate to dryness and dissolve the residue in 15 mL of water R. Filter, boil the filtrate until the volume is reduced to 5 mL and add 1 mL of dilute acetic acid R and 1.5 mL of calcium chloride solution R. Allow to stand for 30 min. No precipitate is formed.<\/p>\n

Sulfates (2.4.13)<\/h3>\n

Maximum 500 ppm.<\/p>\n

To 3.0 mL of solution S add 3 mL of acetic acid R and dilute to 15 mL with distilled water R. Examine the solutions against the light.<\/p>\n

Elemental impurities<\/h3>\n

Any method that fulfils the requirements of general chapter 2.4.20. Determination of elemental impurities may be used.<\/p>\n\n\n\n\n\n\n\n
Element<\/strong><\/td>\n\u00a0Maximum content (ppm)<\/strong><\/td>\n<\/tr>\n
Arsenic<\/td>\n2<\/td>\n<\/tr>\n
Cobalt<\/td>\n25<\/td>\n<\/tr>\n
Nickel<\/td>\n50<\/td>\n<\/tr>\n
Vanadium<\/td>\n50<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Ferric ions<\/h3>\n

Maximum 1.0 per cent.<\/p>\n

In a ground-glass-stoppered flask, dissolve 5.00 g in a mixture of 10 mL of hydrochloric acid R and 100 mL of carbon dioxide-free water R. Add 3 g of potassium iodide R, close the flask and allow to stand protected from light for 5 min.<\/p>\n

Titrate with 0.1 M sodium thiosulfate, using 0.5 mL of starch solution R, added towards the end of the titration, as indicator.<\/p>\n

Carry out a blank titration. Not more than 9.0 mL of 0.1 M sodium thiosulfate is used.<\/p>\n

Loss on drying (2.2.32)<\/h3>\n

5.0 per cent to 10.5 per cent, determined on 0.500 g by drying in an oven at 105 \u00b0C for 5 h.<\/p>\n

Microbial contamination<\/h3>\n

TAMC: acceptance criterion 10 CFU\/g (2.6.12).<\/p>\n

TYMC: acceptance criterion 10 CFU\/g (2.6.12).<\/p>\n

ASSAY<\/h2>\n

Dissolve 0.5 g of sodium hydrogen carbonate R in a mixture of 30 mL of dilute sulfuric acid R and 70 mL of water R. When the effervescence stops, dissolve 1.00 g of the substance to be examined with gentle shaking. Using 0.1 mL of ferroin R as indicator, titrate with 0.1 M ammonium and cerium nitrate until the red colour disappears.<\/p>\n

1 mL of 0.1 M ammonium and cerium nitrate is equivalent to 5.585 mg of iron(II).<\/p>\n

STORAGE<\/h2>\n

Protected from light.<\/p>\n","protected":false},"excerpt":{"rendered":"

(Ph. Eur. monograph 0493) C12H22FeO14,xH2O 446.1 (anhydrous substance) Action and use Used in prevention and treatment of iron deficiency. Preparation Ferrous Gluconate Tablets DEFINITION Iron(II) bis[(2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoate] (iron(II) di(D-gluconate)) hydrate. Content 11.8 per cent to 12.5 per cent of iron(II) (dried substance). It contains a variable quantity of water. CHARACTERS Appearance Greenish-yellow or grey powder or…<\/p>\n","protected":false},"author":4,"featured_media":14729,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-14687","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\/14687","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=14687"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14687\/revisions"}],"predecessor-version":[{"id":14731,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14687\/revisions\/14731"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/14729"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=14687"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=14687"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=14687"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}