{"id":14580,"date":"2025-10-15T14:30:55","date_gmt":"2025-10-15T07:30:55","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=14580"},"modified":"2025-10-15T14:30:55","modified_gmt":"2025-10-15T07:30:55","slug":"ibandronate-sodium-monohydrate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/ibandronate-sodium-monohydrate\/","title":{"rendered":"Ibandronate Sodium Monohydrate"},"content":{"rendered":"

(Ph. Eur. monograph 2771)<\/p>\n

C9<\/sub>H22<\/sub>NNaO7<\/sub>P2<\/sub>,H2<\/sub>O\u00a0 \u00a0359.2\u00a0 \u00a0138926-19-9<\/p>\n

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

Bisphosphonate; treatment of osteolytic lesions; osteoporosis; hypercalcaemia in malignancy<\/p>\n

DEFINITION<\/h2>\n

Monosodium trihydrogen [1-hydroxy-3-[methyl(pentyl)amino]propane-1,1-diyl]bisphosphonate monohydrate.<\/p>\n

Content<\/h3>\n

98.5 per cent to 101.5 per cent (anhydrous substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

White or almost white or yellowish powder.<\/p>\n

Solubility<\/h3>\n

Freely soluble in water, very slightly soluble in ethanol (96 per cent), practically insoluble in acetone.<\/p>\n

IDENTIFICATION<\/h2>\n

A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n

Comparison ibandronate sodium monohydrate CRS.<\/p>\n

B. Dissolve 0.1 g in 2 mL of water R. The solution gives reaction (a) of sodium (2.3.1).<\/p>\n

TESTS<\/h2>\n

Solution S<\/h3>\n

Dissolve 0.5 g in water R and dilute to 10 mL with the same solvent.<\/p>\n

Appearance of solution<\/h3>\n

Solution S is not more opalescent than reference suspension IV (2.2.1) and not more intensely coloured than reference solution B4 (2.2.2, Method II).<\/p>\n

pH (2.2.3)<\/h3>\n

3.9 to 4.2 for solution S.<\/p>\n

Related substances<\/h3>\n

Liquid chromatography (2.2.29).<\/p>\n

Solvent mixture acetonitrile R, ethanol (96 per cent) R (50:50 V\/V).<\/p>\n

Buffer solution pH 2.3: Dissolve 0.25 g of sodium edetate R in 900 mL of water for chromatography R, add 1 mL of trifluoroacetic acid R and 1 mL of triethylamine R; adjust to pH 2.3 with trifluoroacetic acid R or triethylamine R and dilute to 1000 mL with water for chromatography R.<\/p>\n

Solution A: Dissolve 0.25 g of sodium edetate R in water R, add 10 mL of trifluoroacetic acid R and dilute to 1000 mL with water R.<\/p>\n

Test solution: Dissolve 0.40 g of the substance to be examined in solution A and dilute to 10.0 mL with solution A.<\/p>\n

Reference solution (a): Dilute 1.0 mL of the test solution to 100.0 mL with solution A. Dilute 1.0 mL of this solution to 10.0 mL with solution A.<\/p>\n

Reference solution (b): Dilute 25 \u03bcL of acetone R to 50 mL with solution A (solution B). Dissolve 40 mg of the substance to be examined in 1 mL of solution B.<\/p>\n

Column:<\/p>\n

\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n

\u2014 stationary phase: end-capped phenylhexylsilyl silica gel for chromatography R (5 \u03bcm);<\/p>\n

\u2014 temperature: 35 \u00b0C.<\/p>\n

Mobile phase Solvent mixture, buffer solution pH 2.3 (6:94 V\/V).<\/p>\n

Flow rate 1.2 mL\/min.<\/p>\n

Detection Differential refractometer maintained at 40 \u00b0C.<\/p>\n

Injection 30 \u03bcL.<\/p>\n

Run time 4 times the retention time of ibandronate.<\/p>\n

Relative retention With reference to ibandronate (retention time = about 6.5 min): acetone = about 0.7.<\/p>\n

System suitability Reference solution (b):<\/p>\n

\u2014 resolution: minimum 3.0 between the peaks due to acetone and ibandronate.<\/p>\n

Calculation of percentage contents:<\/p>\n

\u2014 for each impurity, use the concentration of ibandronate sodium monohydrate in reference solution (a).<\/p>\n

Limits:<\/p>\n

\u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n

\u2014 total: maximum 0.5 per cent;<\/p>\n

\u2014 reporting threshold: 0.05 per cent.<\/p>\n

Water (2.5.32)<\/h4>\n

4.4 per cent to 5.6 per cent, determined on 50.0 mg using the evaporation technique at 150 \u00b0C.<\/p>\n

ASSAY<\/h2>\n

Dissolve 0.500 g in 50 mL of water R. Carry out a potentiometric titration (2.2.20), using 0.1 M sodium hydroxide. Read the volume added at the 1 inflexion point (not systematically detected) and continue the titration to the 2 inflexion point.<\/p>\n

Calculate the percentage content of C9<\/sub>H22<\/sub>NNaO7<\/sub>P2<\/sub> using the following expression:<\/p>\n

\"Ibandronate<\/p>\n

V1<\/sub> = volume of 0.1 M sodium hydroxide added at the 1 inflexion point (at about pH about 2 to 5), in millilitres (only detected if free phosphates and phosphites are present);<\/p>\n

V2<\/sub> = volume of 0.1 M sodium hydroxide added at the 2 inflexion point (at pH of about 11), in millilitres;<\/p>\n

341.24 = relative molecular mass of anhydrous ibandronate sodium;<\/p>\n

m = mass of the substance to be examined, in grams;<\/p>\n

M = molarity of the sodium hydroxide solution, in moles per litre;<\/p>\n

w = percentage content of water.<\/p>\n

IMPURITIES<\/h2>\n

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, C.<\/p>\n

\"Ibandronate<\/p>\n

A. 3-[methyl(pentyl)amino]propanoic acid,<\/p>\n

\"Ibandronate<\/p>\n

C. [1-hydroxy-3-(pentylamino)propane-1,1-diyl]bis(phosphonic acid).<\/p>\n","protected":false},"excerpt":{"rendered":"

(Ph. Eur. monograph 2771) C9H22NNaO7P2,H2O\u00a0 \u00a0359.2\u00a0 \u00a0138926-19-9 Action and use Bisphosphonate; treatment of osteolytic lesions; osteoporosis; hypercalcaemia in malignancy DEFINITION Monosodium trihydrogen [1-hydroxy-3-[methyl(pentyl)amino]propane-1,1-diyl]bisphosphonate monohydrate. Content 98.5 per cent to 101.5 per cent (anhydrous substance). CHARACTERS Appearance White or almost white or yellowish powder. Solubility Freely soluble in water, very slightly soluble in ethanol (96 per…<\/p>\n","protected":false},"author":3,"featured_media":14598,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-14580","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\/14580","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=14580"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14580\/revisions"}],"predecessor-version":[{"id":14600,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14580\/revisions\/14600"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/14598"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=14580"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=14580"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=14580"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}