{"id":26883,"date":"2025-11-06T12:24:06","date_gmt":"2025-11-06T05:24:06","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=26883"},"modified":"2025-11-06T18:50:07","modified_gmt":"2025-11-06T11:50:07","slug":"oxcarbazepine","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/oxcarbazepine\/","title":{"rendered":"Oxcarbazepine"},"content":{"rendered":"

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

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

Antiepileptic.<\/p>\n

Ph Eur<\/p>\n

\n

DEFINITION<\/h2>\n

10-Oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide.<\/p>\n

Content<\/strong><\/p>\n

97.5 per cent to 102.0 per cent (dried substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

White or faintly orange, crystalline powder.<\/p>\n

Solubility<\/h3>\n

Practically insoluble in water and in ethanol (96 per cent), slightly soluble in methylene chloride.<\/p>\n

IDENTIFICATION<\/h2>\n

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

Comparison\u00a0 oxcarbazepine CRS.<\/em><\/p>\n

TESTS<\/h2>\n

Related substances<\/h3>\n

Liquid chromatography (2.2.29). Carry out the test protected from light. Solvent mixture\u00a0 acetonitrile R, solution A (50:50 V\/V).<\/p>\n

Phosphate buffer solution\u00a0 Dissolve 0.54 g of potassium dihydrogen phosphate R and 8.9 g of disodium hydrogen phosphate dihydrate R in 1.0 L of water R.<\/p>\n

Solution A\u00a0 1.8 g\/L solution of ascorbic acid R.<\/p>\n

Solution B\u00a0 1.8 g\/L solution of sodium edetate R in a mixture of equal volumes of the phosphate buffer solution and water R.<\/p>\n

Test solution (a)\u00a0 Dissolve 50.0 mg of the substance to be examined in 25 mL of acetonitrile R, sonicate for 10 min, cool to room temperature and dilute to 50.0 mL with solution A.<\/p>\n

Test solution (b)\u00a0 Dilute 5.0 mL of test solution (a) to 50.0 mL with the solvent mixture.<\/p>\n

Reference solution (a)\u00a0 Dissolve the contents of a vial of oxcarbazepine impurity mixture CRS (impurities A, B, I and K) in 0.5 mL of acetonitrile R and dilute to 1.0 mL with solution A.<\/p>\n

Reference solution (b)\u00a0 Dilute 1.0 mL of test solution (a) 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 (c)\u00a0 Dissolve 50.0 mg of oxcarbazepine CRS in 25 mL of acetonitrile R, sonicate for 10 min, cool to room temperature and dilute to 50.0 mL with solution A. Dilute 5.0 mL of this solution to 50.0 mL with the solvent mixture.<\/p>\n

Column:<\/p>\n

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

\u2014 stationary phase: phenylhexylsilyl silica gel for chromatography R (5 \u00b5m);<\/p>\n

\u2014 temperature: 40 \u00b0C.<\/p>\n

Mobile phase:<\/p>\n

\u2014 mobile phase A: acetonitrile R, solution B, tetrahydrofuran R, water R (5:10:10:75 V\/V\/V\/V);<\/p>\n

\u2014 mobile phase B: solution B, tetrahydrofuran R, water R, acetonitrile R (10:10:20:60 V\/V\/V\/V);<\/p>\n\n\n\n\n\n\n
Time (min)<\/strong><\/td>\nMobile phase A (per cent V\/V)<\/strong><\/td>\nMobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 10<\/td>\n60<\/td>\n40<\/td>\n<\/tr>\n
10 – 20<\/td>\n60 \u2192 5<\/td>\n40 \u2192 95<\/td>\n<\/tr>\n
20 – 27<\/td>\n5<\/td>\n95<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Flow rate\u00a0 1.0 mL\/min.<\/p>\n

Detection\u00a0 Spectrophotometer at 240 nm.<\/p>\n

Injection\u00a0 10 \u00b5L of test solution (a) and reference solutions (a) and (b).<\/p>\n

Identification of impurities\u00a0 Use the chromatogram supplied with oxcarbazepine impurity mixture CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities A, B, I and K.<\/p>\n

Relative retention\u00a0 With reference to oxcarbazepine (retention time = about 6 min): impurity I = about 0.8; impurity A = about 1.3; impurities K and L = about 1.4; impurity B = about 1.6.<\/p>\n

System suitability\u00a0 Reference solution (a):<\/p>\n

\u2014 peak-to-valley ratio: minimum 4.0, where Hp = height above the baseline of the peak due to impurities K and L and Hv = height above the baseline of the lowest point of the curve separating this peak from the peak due to impurity A.<\/p>\n

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

\u2014 for each impurity, use the concentration of oxcarbazepine in reference solution (b).<\/p>\n

Limits:<\/p>\n

\u2014 impurities B, I: for each impurity, maximum 0.1 per cent;<\/p>\n

\u2014 sum of impurities K and L: maximum 0.1 per cent;<\/p>\n

\u2014 unspecified impurities: for each impurity, maximum 0.05 per cent;<\/p>\n

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

\u2014 reporting threshold: 0.03 per cent.<\/p>\n

Loss on drying (2.2.32)<\/strong><\/p>\n

Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<\/p>\n

Sulfated ash (2.4.14)<\/strong><\/p>\n

Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n

ASSAY<\/h2>\n

Liquid chromatography (2.2.29) as described in the test for related substances with the following modifications.<\/p>\n

Mobile phase:<\/p>\n\n\n\n\n\n\n
Time (min)<\/strong><\/td>\nMobile phase A (per cent V\/V)<\/strong><\/td>\nMobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 7<\/td>\n60<\/td>\n40<\/td>\n<\/tr>\n
7 – 8<\/td>\n60 \u2192 5<\/td>\n40 \u2192 95<\/td>\n<\/tr>\n
8 – 13<\/td>\n5<\/td>\n95<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Injection\u00a0 Test solution (b) and reference solution (c).<\/p>\n

Calculate the percentage content of C15<\/sub>H12<\/sub>N2<\/sub>O2<\/sub> taking into account the assigned content of oxcarbazepine CRS.<\/p>\n

IMPURITIES<\/h2>\n

Specified impurities\u00a0 B, I, K, L.<\/em><\/p>\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.<\/em><\/p>\n

Control of impurities in substances for pharmaceutical use)\u00a0 A, C, D, E, F, G, H, M.<\/em><\/p>\n

\"Oxcarbazepine\"<\/p>\n

A. 5H-dibenzo[b,f]azepine-5-carboxamide (carbamazepine),<\/p>\n

\"Oxcarbazepine\"<\/p>\n

B. 10-methoxy-5H-dibenzo[b,f]azepine-5-carboxamide (10-methoxycarbamazepine),<\/p>\n

\"Oxcarbazepine\"<\/p>\n

C. 5,11-dihydro-10H-dibenzo[b,f]azepin-10-one,<\/p>\n

\"Oxcarbazepine\"<\/p>\n

D. 5H-dibenzo[b,f]azepine-10,11-dione,<\/p>\n

\"Oxcarbazepine\"<\/p>\n

E. 5H-dibenzo[b,f]azepine,<\/p>\n

\"Oxcarbazepine\"<\/p>\n

F. 10-methoxy-5H-dibenzo[b,f]azepine-5-carbonyl chloride,<\/p>\n

\"Oxcarbazepine\"<\/p>\n

G. 5-ethyl-10-methoxy-5H-dibenzo[b,f]azepine,<\/p>\n

\"Oxcarbazepine\"<\/p>\n

H. 10-methoxy-5H-dibenzo[b,f]azepine,<\/p>\n

\"Oxcarbazepine\"<\/p>\n

I. 10,11-dioxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide,<\/p>\n

\"Oxcarbazepine\"<\/p>\n

K. N-formyl-10-oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide,<\/p>\n

\"Oxcarbazepine\"<\/p>\n

L. N-acetyl-10-oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide,<\/p>\n

\"Oxcarbazepine\"<\/p>\n

M. 10-[[(10-oxo-10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)carbonyl]amino]-5H-dibenzo[b,f]azepine-5-\u00a0 carboxamide.<\/p>\n

\n

Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Antiepileptic. Ph Eur DEFINITION 10-Oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide. Content 97.5 per cent to 102.0 per cent (dried substance). CHARACTERS Appearance White or faintly orange, crystalline powder. Solubility Practically insoluble in water and in ethanol (96 per cent), slightly soluble in methylene chloride. IDENTIFICATION Infrared absorption spectrophotometry (2.2.24). Comparison\u00a0…<\/p>\n","protected":false},"author":5,"featured_media":26884,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-26883","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\/26883","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=26883"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26883\/revisions"}],"predecessor-version":[{"id":27421,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26883\/revisions\/27421"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/26884"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=26883"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=26883"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=26883"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}