{"id":2853,"date":"2025-09-22T16:29:27","date_gmt":"2025-09-22T09:29:27","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=2853"},"modified":"2025-10-01T14:44:35","modified_gmt":"2025-10-01T07:44:35","slug":"acebutolol-capsules","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/acebutolol-capsules\/","title":{"rendered":"Acebutolol Capsules"},"content":{"rendered":"

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

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

Beta-adrenergic receptor antagonist.<\/span><\/span><\/span><\/span><\/p>\n

DEFINITION<\/span><\/span><\/span><\/span><\/h2>\n
Acebutolol capsules contain Acebutolol Hydrochloride.<\/span><\/span><\/span><\/span><\/p>\n
The capsules comply with the requirements given in the section Capsules and the following requirements.<\/span><\/span><\/span><\/span><\/p>\n
Acebutolol content, C <\/span><\/span><\/span><\/span>_{18<\/span><\/span><\/span><\/span><\/sub> H <\/span><\/span><\/span><\/span>_{28<\/span><\/span><\/span><\/span><\/sub> N <\/span><\/span><\/span><\/span>_{2<\/span><\/span><\/span><\/span><\/sub> O <\/span><\/span><\/span><\/span>_{4<\/span><\/span><\/span><\/span><\/sub><\/p>\n}}}}
95.0 to 105.0% of the stated amount.<\/span><\/span><\/span><\/span><\/p>\n
IDENTIFICATION<\/span><\/span><\/span><\/span><\/h2>\n
The infrared absorption spectrum of a 0.7% w\/w dispersion of the capsule contents in potassium chloride, Annex II A, was consistent with the reference spectrum of Acebutolol hydrochloride (RS 380).<\/span><\/span><\/span><\/span><\/p>\n
CHECK<\/span><\/span><\/span><\/span><\/h2>\n
Related substances<\/span><\/span><\/span><\/span><\/h3>\n
Perform thin layer chromatography, Appendix III A, using the following solutions.<\/span><\/span><\/span><\/span><\/p>\n
(1) Add to the contents of a capsule containing the equivalent of 0.4 g Acebutolol 20 mL of an equal volume mixture of chloroform and methanol, shake for 2 minutes, centrifuge, and use the supernatant.<\/span><\/span><\/span><\/span><\/p>\n
(2) Dilute 3 volumes of solution (1) to 100 volumes with a mixture of equal volumes of chloroform and methanol and further dilute 1 volume of this solution to 10 volumes with the same solvent mixture.<\/span><\/span><\/span><\/span><\/p>\n
(3) Dilute 1 volume of solution (1) to 100 volumes with a mixture of equal volumes of chloroform and methanol and further dilute 1 volume of this solution to 10 volumes with the same solvent mixture.<\/span><\/span><\/span><\/span><\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/span><\/span><\/span><\/span><\/h3>\n
(a) Use a pre-coated F254 silica gel plate (Merck F254 silica gel 60 plates are suitable). <\/span><\/span><\/span><\/span>
\n(b) Use the mobile phase as described below. <\/span><\/span><\/span><\/span>
\n(c) Add 10 \u03bcL of each solution. <\/span><\/span><\/span><\/span>
\n(d) Develop the plate to 15 cm. <\/span><\/span><\/span><\/span>
\n(e) After removing the plate, allow it to air dry and examine under UV light (254 nm).<\/span><\/span><\/span><\/span><\/p>\n
MOBILE PHASE<\/span><\/span><\/span><\/span><\/h3>\n
20 volumes of glacial acetic acid, 20 volumes of dimethylformamide and 60 volumes of chloroform.<\/span><\/span><\/span><\/span><\/p>\n
LIMIT<\/span><\/span><\/span><\/span><\/h3>\n
In the chromatogram obtained with solution (1):<\/span><\/span><\/span><\/span><\/p>\n
Any secondary spot is not more intense than the spot in the chromatogram obtained with solution (2) (0.3%);<\/span><\/span><\/span><\/span><\/p>\n
Not more than two such spots are more intense than the spot in the chromatogram obtained with solution (3) (0.1%).<\/span><\/span><\/span><\/span><\/p>\n
Discard any remaining residue on the smear.<\/span><\/span><\/span><\/span><\/p>\n
TESTING<\/span><\/span><\/span><\/span><\/h2>\n
Take a mixture of 20 capsules containing the equivalent of 0.15 g Acebutolol, add 150 mL of water, <\/span><\/span><\/span><\/span>
\nshake for 10 minutes, add enough water to make 250 mL, centrifuge and dilute 10 mL of the supernatant to <\/span><\/span><\/span><\/span>
\n100 mL with water. Take 10 mL of this solution, add 10 mL of 0.1 M hydrochloric acid solution and enough water to make 100 mL. <\/span><\/span><\/span><\/span>
\nMeasure the absorbance of this solution, Appendix II B, at the maximum wavelength of 233 nm and calculate the content of C <\/span><\/span>_{18<\/span><\/span><\/sub> H <\/span><\/span>_{28<\/span><\/span><\/sub> N <\/span><\/span>_{2<\/span><\/span><\/sub> O <\/span><\/span>_{4<\/span><\/span><\/sub><\/span> in the capsule, taking <\/span><\/span><\/span><\/span>\u00a0643 as the value A <\/span><\/span><\/span>(1%, 1 cm) at the maximum wavelength of 233 nm <\/span><\/span><\/span>.<\/span><\/span><\/span><\/span><\/p>\n}}}}
TREAT<\/span><\/span><\/span><\/span><\/h2>\n
Acebutolol capsules must be protected from light.<\/span><\/span><\/span><\/span><\/p>\n
LABELING<\/span><\/span><\/span><\/span><\/h2>\n
The amount of active ingredient is stated in terms of acebutolol equivalents.<\/span><\/span><\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"
Version: BP 2025 (Ph. Eur. 11.6 update) Action and use Beta-adrenergic receptor antagonist. DEFINITION Acebutolol capsules contain Acebutolol Hydrochloride. The capsules comply with the requirements given in the section Capsules and the following requirements. Acebutolol content, C 18 H 28 N 2 O 4 95.0 to 105.0% of the stated amount. IDENTIFICATION The infrared absorption…<\/p>\n","protected":false},"author":5,"featured_media":2903,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-2853","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-volumes-1-2"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/2853","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=2853"}],"version-history":[{"count":7,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/2853\/revisions"}],"predecessor-version":[{"id":5781,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/2853\/revisions\/5781"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/2903"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=2853"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=2853"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=2853"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}