{"id":22892,"date":"2025-10-30T17:38:33","date_gmt":"2025-10-30T10:38:33","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=22892"},"modified":"2025-10-30T17:38:33","modified_gmt":"2025-10-30T10:38:33","slug":"cloprostenol-sodium","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/cloprostenol-sodium\/","title":{"rendered":"Cloprostenol Sodium"},"content":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n

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

Prostaglandin (PGF2\u03b1) analogue.<\/p>\n

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

Cloprostenol Injection<\/p>\n

DEFINITION<\/h2>\n
Cloprostenol Sodium is (\u00b1)-(5Z)-7-(1R,3R,5S)-2-[(1E,3R)-4-(3-chlorophenoxy)-3-hydroxybut-1-enyl]-3,5- dihydroxycyclopentylhept-5-enoate. It contains not less than 97.5% and not more than 102.5% of C_{22<\/sub>H_{28<\/sub>ClNaO_{6<\/sub>, calculated with reference to the anhydrous substance.<\/p>\n}}}
CAUTION Cloprostenol Sodium is extremely potent and extraordinary care should be taken in any procedure in which it is used.<\/em><\/p>\n
CHARACTERISTICS<\/h2>\n
A white or almost white, amorphous powder; hygroscopic.<\/p>\n
Freely soluble in water, in ethanol (96%) and in methanol; practically insoluble in acetone.<\/p>\n
IDENTIFICATION<\/h2>\n
A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of cloprostenol sodium\u00a0(RSV 11).<\/p>\n
B. Yields reaction A characteristic of sodium salts, Appendix VI.<\/p>\n
TESTS<\/h2>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in absolute ethanol.<\/p>\n
(1) 2.0% w\/v of the substance being examined.<\/p>\n
(2) 0.050% w\/v of the substance being examined.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with silica gel for chromatography (5 \u00b5m) (Partisil is suitable).<\/p>\n
(b) Use isocratic elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1.8 mL per minute.<\/p>\n
(d) Use an ambient column temperature.<\/p>\n
(e) Use a detection wavelength of 220 nm.<\/p>\n
(f) Inject 5 \u00b5L of each solution.<\/p>\n
(g) Allow the chromatography to proceed for twice the retention time of the peak due to Cloprostenol.<\/p>\n
MOBILE PHASE<\/h4>\n
1 volume of glacial acetic acid, 70 volumes of absolute ethanol and 930 volumes of hexane.<\/p>\n
LIMITS<\/h4>\n
In the chromatogram obtained with solution (1):<\/p>\n
the sum of the areas of any secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (2.5%).<\/p>\n
Water<\/h3>\n
Not more than 3.0% w\/w, Appendix IX C. Use 50 mg dissolved in 1 mL of absolute ethanol.<\/p>\n
ASSAY<\/h2>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in absolute ethanol.<\/p>\n
(1) 0.08% w\/v of the substance being examined.<\/p>\n
(2) 0.08% w\/v of cloprostenol sodium BPCRS.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with silica gel for chromatography (5 \u00b5m) (Partisil is suitable).<\/p>\n
(b) Use isocratic elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1.8 mL per minute.<\/p>\n
(d) Use an ambient column temperature.<\/p>\n
(e) Use a detection wavelength of 220 nm.<\/p>\n
(f) Inject 5 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h3>\n
1 volume of glacial acetic acid, 100 volumes of absolute ethanol and 900 volumes of hexane.<\/p>\n
DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C_{22<\/sub>H_{28<\/sub>ClNaO_{6<\/sub> from the chromatograms obtained and using the declared content of C_{22<\/sub>H_{28<\/sub>ClNaO_{6<\/sub> in cloprostenol sodium BPCRS.<\/p>\n}}}}}}
STORAGE<\/h2>\n
Cloprostenol Sodium should be protected from light and moisture.<\/p>\n
IMPURITIES<\/h2>\n
$\"Cloprostenol$ <\/p>\n
A. (\u00b1)-(5Z )-7-(1R,3R,5S)-2-[(1E,3S)-4-(3-chlorophenoxy)-3-hydroxybut-1-enyl]-3,5-dihydroxycyclopentylhept-5-enoate (epimer),<\/p>\n
$\"Cloprostenol$ <\/p>\n
B. (\u00b1)-(5E )-7-(1R,3R,5S)-2-[(1E,3 R)-4-(3-chlorophenoxy)-3-hydroxybut-1-enyl]-3,5-dihydroxycyclopentylhept-5-enoate (trans-isomer).<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Prostaglandin (PGF2\u03b1) analogue. Preparation Cloprostenol Injection DEFINITION Cloprostenol Sodium is (\u00b1)-(5Z)-7-(1R,3R,5S)-2-[(1E,3R)-4-(3-chlorophenoxy)-3-hydroxybut-1-enyl]-3,5- dihydroxycyclopentylhept-5-enoate. It contains not less than 97.5% and not more than 102.5% of C22H28ClNaO6, calculated with reference to the anhydrous substance. CAUTION Cloprostenol Sodium is extremely potent and extraordinary care should be taken in…<\/p>\n","protected":false},"author":5,"featured_media":22893,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-22892","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-british-pharmacopoeia-veterinary-2020"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22892","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\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=22892"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22892\/revisions"}],"predecessor-version":[{"id":22898,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22892\/revisions\/22898"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22893"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22892"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22892"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22892"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

IDENTIFICATION<\/h2>\nA. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of cloprostenol sodium\u00a0(RSV 11).<\/p>\nB. Yields reaction A characteristic of sodium salts, Appendix VI.<\/p>\n

TESTS<\/h2>\n

Related substances<\/h3>\nCarry out the method for liquid chromatography, Appendix III D, using the following solutions in absolute ethanol.<\/p>\n(1) 2.0% w\/v of the substance being examined.<\/p>\n(2) 0.050% w\/v of the substance being examined.<\/p>\n

MOBILE PHASE<\/h4>\n1 volume of glacial acetic acid, 70 volumes of absolute ethanol and 930 volumes of hexane.<\/p>\n

LIMITS<\/h4>\nIn the chromatogram obtained with solution (1):<\/p>\nthe sum of the areas of any secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (2.5%).<\/p>\n

Water<\/h3>\nNot more than 3.0% w\/w, Appendix IX C. Use 50 mg dissolved in 1 mL of absolute ethanol.<\/p>\n

ASSAY<\/h2>\nCarry out the method for liquid chromatography, Appendix III D, using the following solutions in absolute ethanol.<\/p>\n(1) 0.08% w\/v of the substance being examined.<\/p>\n(2) 0.08% w\/v of cloprostenol sodium BPCRS.<\/p>\n

MOBILE PHASE<\/h3>\n1 volume of glacial acetic acid, 100 volumes of absolute ethanol and 900 volumes of hexane.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\nCalculate the content of C22<\/sub>H28<\/sub>ClNaO6<\/sub> from the chromatograms obtained and using the declared content of C22<\/sub>H28<\/sub>ClNaO6<\/sub> in cloprostenol sodium BPCRS.<\/p>\n

STORAGE<\/h2>\nCloprostenol Sodium should be protected from light and moisture.<\/p>\n

IDENTIFICATION<\/h2>\n
A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of cloprostenol sodium\u00a0(RSV 11).<\/p>\n
B. Yields reaction A characteristic of sodium salts, Appendix VI.<\/p>\n

Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in absolute ethanol.<\/p>\n
(1) 2.0% w\/v of the substance being examined.<\/p>\n
(2) 0.050% w\/v of the substance being examined.<\/p>\n

MOBILE PHASE<\/h4>\n
1 volume of glacial acetic acid, 70 volumes of absolute ethanol and 930 volumes of hexane.<\/p>\n

LIMITS<\/h4>\n
In the chromatogram obtained with solution (1):<\/p>\n
the sum of the areas of any secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (2.5%).<\/p>\n

Water<\/h3>\n
Not more than 3.0% w\/w, Appendix IX C. Use 50 mg dissolved in 1 mL of absolute ethanol.<\/p>\n

ASSAY<\/h2>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in absolute ethanol.<\/p>\n
(1) 0.08% w\/v of the substance being examined.<\/p>\n
(2) 0.08% w\/v of cloprostenol sodium BPCRS.<\/p>\n

MOBILE PHASE<\/h3>\n
1 volume of glacial acetic acid, 100 volumes of absolute ethanol and 900 volumes of hexane.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C_{22<\/sub>H_{28<\/sub>ClNaO_{6<\/sub> from the chromatograms obtained and using the declared content of C_{22<\/sub>H_{28<\/sub>ClNaO_{6<\/sub> in cloprostenol sodium BPCRS.<\/p>\n}}}}}}

STORAGE<\/h2>\n
Cloprostenol Sodium should be protected from light and moisture.<\/p>\n