{"id":26898,"date":"2025-11-06T13:58:32","date_gmt":"2025-11-06T06:58:32","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=26898"},"modified":"2025-11-06T13:58:32","modified_gmt":"2025-11-06T06:58:32","slug":"pantoprazole-sodium-sesquihydrate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/pantoprazole-sodium-sesquihydrate\/","title":{"rendered":"Pantoprazole Sodium Sesquihydrate"},"content":{"rendered":"

(Ph. Eur. monograph 2296)<\/p>\n

C_{16<\/sub>H_{14<\/sub>F_{2<\/sub>N_{3<\/sub>NaO_{4<\/sub>S,11\u20442H_{2<\/sub>O\u00a0 \u00a0 \u00a0 \u00a0432.4\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0164579-32-2<\/p>\n}}}}}}

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

Proton pump inhibitor; treatment of peptic ulcer disease.<\/p>\n

Preparations<\/strong><\/p>\n

Pantoprazole for Injection<\/p>\n

Pantoprazole Gastro-resistant Tablets\u01b0<\/p>\n

DEFINITION<\/h2>\n
Sodium 5-(difluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]benzimidazol-1-ide sesquihydrate.<\/p>\n
Content<\/h3>\n
99.0 per cent to 101.0 per cent (anhydrous substance).<\/p>\n
PRODUCTION<\/h2>\n
It is produced by methods of manufacture designed to guarantee the proper hydrate form and it complies, if tested, with a suitable test that demonstrates its sesquihydrate nature (for example near-infrared spectroscopy (2.2.40) or X-ray powder diffraction (2.9.33)).<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
White or almost white powder.<\/p>\n
Solubility<\/h3>\n
Freely soluble in water and in ethanol (96 per cent), practically insoluble in hexane.<\/p>\n
IDENTIFICATION<\/h2>\n
A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: pantoprazole sodium sesquihydrate CRS.<\/p>\n
B. It 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 B_{6<\/sub> (2.2.2, Method II).<\/p>\n}
Dissolve 0.20 g in water R and dilute to 20.0 mL with the same solvent.<\/p>\n
Optical rotation (2.2.7)<\/h4>\n
-0.4\u00b0 to + 0.4\u00b0.<\/p>\n
Dissolve 0.2 g in 10 mL of water R. Adjust to pH 11.5-12.0 with an 8 g\/L solution of sodium hydroxide R. Dilute to 20.0 mL with water R.<\/p>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29).<\/p>\n
Solvent mixture: acetonitrile R, 40 mg\/L solution of sodium hydroxide R (50:50 V\/V).<\/p>\n
Test solution: Dissolve 23 mg of the substance to be examined in the solvent mixture and dilute to 50.0 ml with the solvent mixture.<\/p>\n
Reference solution (a): Dilute 1.0 mL of the test solution to 100.0 mL with the solvent mixture. Dilute 1.0 mL of this solution to 10.0 mL with the solvent mixture.<\/p>\n
Reference solution (b): Dissolve 2.5 mg of pantoprazole for system suitability CRS (containing impurities A, B, C, D and E) in the solvent mixture and dilute to 5.0 mL with the solvent mixture.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.125 m, \u00d8 = 4 mm;<\/p>\n
\u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm);<\/p>\n
\u2014 temperature: 40 \u00b0C.<\/p>\n
Mobile phase:<\/p>\n
\u2014 mobile phase A: 1.74 g\/L solution of dipotassium hydrogen phosphate R adjusted to pH 7.00 \u00b1 0.05 with a 330 g\/L solution of phosphoric acid R;<\/p>\n
\u2014 mobile phase B: acetonitrile for chromatography R;<\/p>\n\n\n\n\n\n
Time<\/strong>
\n(min)<\/strong><\/td>\n Mobile phase A<\/strong>
\n(per cent V\/V)<\/strong><\/td>\n Mobile phase B<\/strong>
\n(per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 40<\/td>\n 80 \u2192 20<\/td>\n 20 \u2192 80<\/td>\n<\/tr>\n
40 – 45<\/td>\n 20 \u2192 80<\/td>\n 80 \u2192 20<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Flow rate: 1.0 mL\/min.<\/p>\n
Detection: Spectrophotometer at 290 nm and, for impurity C, at 305 nm.
\nInjection 20 \u03bcL.<\/p>\n
Identification of impurities: Use the chromatogram supplied with pantoprazole for system suitability CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A, B, C, D + F and E.<\/p>\n
Relative retention: With reference to pantoprazole (retention time = about 11 min): impurity C = about 0.6; impurity A = about 0.9; impurities D and F = about 1.2; impurity E = about 1.3; impurity B = about 1.5.<\/p>\n
System suitability: Reference solution (b):<\/p>\n
\u2014 resolution: minimum 1.5 between the peaks due to impurities E and D + F;<\/p>\n
\u2014 the chromatogram obtained is similar to the chromatogram supplied with pantoprazole for system suitability CRS.<\/p>\n
Limits:<\/p>\n
\u2014 correction factor: for the calculation of content, multiply the peak area of impurity C by 0.3;<\/p>\n
\u2014 impurity A: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (a) (0.2 per cent);<\/p>\n
\u2014 sum of impurities D and F: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (a) (0.2 per cent);<\/p>\n
\u2014 impurities B, C, E: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.1 per cent);<\/p>\n
\u2014 unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.10 per cent);<\/p>\n
\u2014 total: not more than 5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.5 per cent);<\/p>\n
\u2014 disregard limit: 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent).<\/p>\n
Water (2.5.12)<\/h4>\n
5.9 per cent to 6.9 per cent, determined on 0.150 g.<\/p>\n
ASSAY<\/h2>\n
Dissolve 0.200 g in 80 mL of anhydrous acetic acid R, add 5 mL of acetic anhydride R and mix for at least 10 min. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n
1 mL of 0.1 M perchloric acid is equivalent to 20.27 mg of C_{16<\/sub>H_{14<\/sub>F_{2<\/sub>N_{3<\/sub>NaO_{4<\/sub>S.<\/p>\n}}}}}
STORAGE<\/h2>\n
Protected from light.<\/p>\n
IMPURITIES<\/h2>\n
Specified impurities A, B, C, D, E, F.<\/p>\n
$\"Pantoprazole$ <\/p>\n
A. 5-(difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-yl)methyl]sulfonyl]-1H-benzimidazole,<\/p>\n
$\"Pantoprazole$ <\/p>\n
B. 5-(difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-yl)methyl]sulfanyl]-1H-benzimidazole,<\/p>\n
$\"Pantoprazole$ <\/p>\n
C. 5-(difluoromethoxy)-1H-benzimidazole-2-thiol,<\/p>\n
$\"Pantoprazole$ <\/p>\n
D. 5-(difluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1-methyl-1H-benzimidazole,<\/p>\n
$\"Pantoprazole$ <\/p>\n
E. mixture of the stereoisomers of 6,6\u2032-bis(difluoromethoxy)-2,2\u2032-bis[[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1H,1\u2032H-5,5\u2032-bibenzimidazolyl,<\/p>\n
$\"Pantoprazole$ <\/p>\n
F. 6-(difluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1-methyl-1H-benzimidazole.<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. monograph 2296) C16H14F2N3NaO4S,11\u20442H2O\u00a0 \u00a0 \u00a0 \u00a0432.4\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0164579-32-2 Action and use Proton pump inhibitor; treatment of peptic ulcer disease. Preparations Pantoprazole for Injection Pantoprazole Gastro-resistant Tablets\u01b0 DEFINITION Sodium 5-(difluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]benzimidazol-1-ide sesquihydrate. Content 99.0 per cent to 101.0 per cent (anhydrous substance). PRODUCTION It is produced by methods of manufacture designed to…<\/p>\n","protected":false},"author":2,"featured_media":26908,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-26898","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\/26898","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=26898"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26898\/revisions"}],"predecessor-version":[{"id":26911,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26898\/revisions\/26911"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/26908"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=26898"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=26898"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=26898"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Content<\/h3>\n99.0 per cent to 101.0 per cent (anhydrous substance).<\/p>\n

PRODUCTION<\/h2>\nIt is produced by methods of manufacture designed to guarantee the proper hydrate form and it complies, if tested, with a suitable test that demonstrates its sesquihydrate nature (for example near-infrared spectroscopy (2.2.40) or X-ray powder diffraction (2.9.33)).<\/p>\n

CHARACTERS<\/h2>\n

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

Solubility<\/h3>\nFreely soluble in water and in ethanol (96 per cent), practically insoluble in hexane.<\/p>\n

IDENTIFICATION<\/h2>\nA. Infrared absorption spectrophotometry (2.2.24).<\/p>\nComparison: pantoprazole sodium sesquihydrate CRS.<\/p>\nB. It 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 B6<\/sub> (2.2.2, Method II).<\/p>\nDissolve 0.20 g in water R and dilute to 20.0 mL with the same solvent.<\/p>\n

Optical rotation (2.2.7)<\/h4>\n-0.4\u00b0 to + 0.4\u00b0.<\/p>\nDissolve 0.2 g in 10 mL of water R. Adjust to pH 11.5-12.0 with an 8 g\/L solution of sodium hydroxide R. Dilute to 20.0 mL with water R.<\/p>\n

Water (2.5.12)<\/h4>\n5.9 per cent to 6.9 per cent, determined on 0.150 g.<\/p>\n

STORAGE<\/h2>\nProtected from light.<\/p>\n

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

PRODUCTION<\/h2>\n
It is produced by methods of manufacture designed to guarantee the proper hydrate form and it complies, if tested, with a suitable test that demonstrates its sesquihydrate nature (for example near-infrared spectroscopy (2.2.40) or X-ray powder diffraction (2.9.33)).<\/p>\n

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

Solubility<\/h3>\n
Freely soluble in water and in ethanol (96 per cent), practically insoluble in hexane.<\/p>\n

IDENTIFICATION<\/h2>\n
A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: pantoprazole sodium sesquihydrate CRS.<\/p>\n
B. It 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 B_{6<\/sub> (2.2.2, Method II).<\/p>\n}
Dissolve 0.20 g in water R and dilute to 20.0 mL with the same solvent.<\/p>\n

Optical rotation (2.2.7)<\/h4>\n
-0.4\u00b0 to + 0.4\u00b0.<\/p>\n
Dissolve 0.2 g in 10 mL of water R. Adjust to pH 11.5-12.0 with an 8 g\/L solution of sodium hydroxide R. Dilute to 20.0 mL with water R.<\/p>\n

Water (2.5.12)<\/h4>\n
5.9 per cent to 6.9 per cent, determined on 0.150 g.<\/p>\n

STORAGE<\/h2>\n
Protected from light.<\/p>\n