{"id":26389,"date":"2025-11-05T16:25:47","date_gmt":"2025-11-05T09:25:47","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=26389"},"modified":"2025-11-05T16:25:47","modified_gmt":"2025-11-05T09:25:47","slug":"pamidronate-disodium-pentahydrate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/pamidronate-disodium-pentahydrate\/","title":{"rendered":"Pamidronate Disodium Pentahydrate"},"content":{"rendered":"

Disodium Pamidronate<\/p>\n

(Ph. Eur. monograph 1779)<\/p>\n

C_{3<\/sub>H_{9<\/sub>NNa_{2<\/sub>O_{7<\/sub>P_{2<\/sub>,5H_{2<\/sub>O\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 369.1\u00a0 \u00a0 \u00a0 \u00a0 \u00a0109552-15-0<\/p>\n}}}}}}

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

Bisphosphonate; treatment of osteolytic lesions; Paget\u2019s disease; hypercalcaemia of malignancy.<\/p>\n

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

Pamidronate Disodium Infusion<\/p>\n

DEFINITION<\/h2>\n
Disodium dihydrogen (3-amino-1-hydroxypropylidene)bisphosphonate pentahydrate.<\/p>\n
Content<\/h3>\n
98.0 per cent to 101.0 per cent (anhydrous substance).<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
White or almost white, crystalline powder.<\/p>\n
Solubility<\/h3>\n
Soluble in water, practically insoluble in methylene chloride. It is sparingly soluble in dilute mineral acids and dissolves in dilute alkaline solutions.<\/p>\n
IDENTIFICATION<\/h2>\n
A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: pamidronate disodium pentahydrate CRS.<\/p>\n
B. Dissolve 0.5 g in 10 mL of water R. The solution gives reaction (a) of sodium (2.3.1).<\/p>\n
TESTS<\/h2>\n
Appearance of solution<\/h3>\n
The solution is clear (2.2.1) and not more intensely coloured than reference solution Y_{6<\/sub> (2.2.2, Method II).<\/p>\n}
Dissolve 0.20 g in carbon dioxide-free water R and dilute to 10 mL with the same solvent.<\/p>\n
pH (2.2.3)<\/h4>\n
7.8 to 8.8.<\/p>\n
Dissolve 0.100 g in carbon dioxide-free water R and dilute to 10 mL with the same solvent.<\/p>\n
Impurity A<\/h3>\n
Thin-layer chromatography (2.2.27).<\/p>\n
Test solution: Dissolve 30 mg of the substance to be examined in water R and dilute to 10.0 mL with the same solvent.<\/p>\n
Reference solution: Dissolve 15 mg of 3-aminopropionic acid R in water R and dilute to 100.0 mL with the same solvent. Dilute 1.0 mL of this solution to 10.0 mL with water R.<\/p>\n
Plate: TLC silica gel plate R.<\/p>\n
Mobile phase: concentrated ammonia R, di-isopropyl ether R, methanol R (4:8:9 V\/V\/V).<\/p>\n
Application: 10 \u03bcL.<\/p>\n
Development: Over 2\/3 of the plate.<\/p>\n
Drying: In a current of warm air.<\/p>\n
Detection: Spray with a ninhydrin solution R. Heat at 100-105 \u00b0C for 15 min.<\/p>\n
Limit:<\/p>\n
\u2014 impurity A: any spot due to impurity A is not more intense than the spot in the chromatogram obtained with the reference solution (0.5 per cent).<\/p>\n
Impurities B and C<\/h3>\n
Liquid chromatography (2.2.29).<\/p>\n
Test solution: Dissolve 20.0 mg of the substance to be examined in water R and dilute to 10.0 mL with the same solvent.<\/p>\n
Reference solution: To 2.0 mL of a 0.3 g\/L solution of phosphoric acid R add 2.0 mL of a 0.25 g\/L solution of phosphorous acid R and dilute to 50.0 mL with water R.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.10 m, \u00d8 = 4.6 mm,<\/p>\n
\u2014 stationary phase: anion-exchange resin R (5 \u03bcm),<\/p>\n
\u2014 temperature: 35 \u00b0C.<\/p>\n
Mobile phase: To 0.5 mL of anhydrous formic acid R add 2500 mL of water R; adjust to pH 3.5 with an 80 g\/L solution of sodium hydroxide R.<\/p>\n
Flow rate: 1.0 mL\/min.<\/p>\n
Detection: Refractometer.<\/p>\n
Injection: 100 \u03bcL.<\/p>\n
Relative retention: With reference to pamidronate (retention time = about 13 min): impurity B = about 1.3; impurity C = about 1.6.<\/p>\n
System suitability: Reference solution:<\/p>\n
\u2014 resolution: minimum 2.5 between the peaks due to impurities B and C.<\/p>\n
Limits:<\/p>\n
\u2014 impurities B, C: for each impurity, not more than the area of the corresponding peaks in the chromatogram obtained with the reference solution (0.5 per cent).<\/p>\n
Water (2.5.12)<\/h4>\n
23.0 per cent to 27.0 per cent, determined on 0.100 g.<\/p>\n
ASSAY<\/h2>\n
Dissolve 0.250 g in 70 mL of water R. Titrate with 0.1 M hydrochloric acid determining the end-point potentiometrically (2.2.20).<\/p>\n
1 mL of 0.1 M hydrochloric acid is equivalent to 27.91 mg of C_{3<\/sub>H_{9<\/sub>NNa_{2<\/sub>O_{7<\/sub>P_{2<\/sub>.<\/p>\n}}}}}
IMPURITIES<\/h2>\n
Specified impurities A, B, C.<\/p>\n
$\"Pamidronate$ <\/p>\n
A. 3-aminopropanoic acid (\u03b2-alanine),<\/p>\n
<\/p>\n
B. H_{3<\/sub>PO_{4<\/sub>: phosphoric acid,<\/p>\n}}
<\/p>\n
C. H_{3<\/sub>PO_{3<\/sub>: phosphorous acid.<\/p>\n","protected":false},"excerpt":{"rendered":"}}
Disodium Pamidronate (Ph. Eur. monograph 1779) C3H9NNa2O7P2,5H2O\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 369.1\u00a0 \u00a0 \u00a0 \u00a0 \u00a0109552-15-0 Action and use Bisphosphonate; treatment of osteolytic lesions; Paget\u2019s disease; hypercalcaemia of malignancy. Preparation Pamidronate Disodium Infusion DEFINITION Disodium dihydrogen (3-amino-1-hydroxypropylidene)bisphosphonate pentahydrate. Content 98.0 per cent to 101.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, crystalline…<\/p>\n","protected":false},"author":2,"featured_media":26408,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-26389","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\/26389","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=26389"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26389\/revisions"}],"predecessor-version":[{"id":26411,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26389\/revisions\/26411"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/26408"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=26389"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=26389"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=26389"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Content<\/h3>\n98.0 per cent to 101.0 per cent (anhydrous substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\nWhite or almost white, crystalline powder.<\/p>\n

Solubility<\/h3>\nSoluble in water, practically insoluble in methylene chloride. It is sparingly soluble in dilute mineral acids and dissolves in dilute alkaline solutions.<\/p>\n

IDENTIFICATION<\/h2>\nA. Infrared absorption spectrophotometry (2.2.24).<\/p>\nComparison: pamidronate disodium pentahydrate CRS.<\/p>\nB. Dissolve 0.5 g in 10 mL of water R. The solution gives reaction (a) of sodium (2.3.1).<\/p>\n

TESTS<\/h2>\n

Appearance of solution<\/h3>\nThe solution is clear (2.2.1) and not more intensely coloured than reference solution Y6<\/sub> (2.2.2, Method II).<\/p>\nDissolve 0.20 g in carbon dioxide-free water R and dilute to 10 mL with the same solvent.<\/p>\n

pH (2.2.3)<\/h4>\n7.8 to 8.8.<\/p>\nDissolve 0.100 g in carbon dioxide-free water R and dilute to 10 mL with the same solvent.<\/p>\n

Water (2.5.12)<\/h4>\n23.0 per cent to 27.0 per cent, determined on 0.100 g.<\/p>\n

ASSAY<\/h2>\nDissolve 0.250 g in 70 mL of water R. Titrate with 0.1 M hydrochloric acid determining the end-point potentiometrically (2.2.20).<\/p>\n1 mL of 0.1 M hydrochloric acid is equivalent to 27.91 mg of C3<\/sub>H9<\/sub>NNa2<\/sub>O7<\/sub>P2<\/sub>.<\/p>\n

Content<\/h3>\n
98.0 per cent to 101.0 per cent (anhydrous substance).<\/p>\n

Appearance<\/h3>\n
White or almost white, crystalline powder.<\/p>\n

Solubility<\/h3>\n
Soluble in water, practically insoluble in methylene chloride. It is sparingly soluble in dilute mineral acids and dissolves in dilute alkaline solutions.<\/p>\n

IDENTIFICATION<\/h2>\n
A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: pamidronate disodium pentahydrate CRS.<\/p>\n
B. Dissolve 0.5 g in 10 mL of water R. The solution gives reaction (a) of sodium (2.3.1).<\/p>\n

Appearance of solution<\/h3>\n
The solution is clear (2.2.1) and not more intensely coloured than reference solution Y_{6<\/sub> (2.2.2, Method II).<\/p>\n}
Dissolve 0.20 g in carbon dioxide-free water R and dilute to 10 mL with the same solvent.<\/p>\n

pH (2.2.3)<\/h4>\n
7.8 to 8.8.<\/p>\n
Dissolve 0.100 g in carbon dioxide-free water R and dilute to 10 mL with the same solvent.<\/p>\n

Water (2.5.12)<\/h4>\n
23.0 per cent to 27.0 per cent, determined on 0.100 g.<\/p>\n

ASSAY<\/h2>\n
Dissolve 0.250 g in 70 mL of water R. Titrate with 0.1 M hydrochloric acid determining the end-point potentiometrically (2.2.20).<\/p>\n
1 mL of 0.1 M hydrochloric acid is equivalent to 27.91 mg of C_{3<\/sub>H_{9<\/sub>NNa_{2<\/sub>O_{7<\/sub>P_{2<\/sub>.<\/p>\n}}}}}