Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Zinc bis(6-acetamidohexanoate).<\/p>\n
Content<\/strong><\/p>\n 97.5 per cent to 101.0 per cent (dried substance).<\/p>\n White or almost white, crystalline powder.<\/p>\n Soluble in water, practically insoluble in acetone and in ethanol (96 per cent). It dissolves in dilute nitric acid.<\/p>\n About 198 \u00b0C.<\/p>\n A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison\u00a0 zinc acexamate CRS.<\/p>\n B. 5 mL of solution S (see Tests) gives the reaction of zinc (2.3.1).<\/p>\n Dissolve 0.5 g in carbon dioxide-free water R and dilute to 20 mL with the same solvent.<\/p>\n Solution S is not more opalescent than reference suspension IV (2.2.1) and is colourless (2.2.2, Method II).<\/p>\n pH (2.2.3)<\/strong><\/p>\n 5.0 to 7.0 for solution S.<\/p>\n Thin-layer chromatography (2.2.27).<\/p>\n Test solution\u00a0 Dissolve 0.30 g of the substance to be examined in water R and dilute to 10 mL with the same solvent.<\/p>\n Reference solution Dissolve 15 mg of 6-aminohexanoic acid R (impurity B) in water R and dilute to 10 mL with the same solvent. Dilute 1 mL of this solution to 10 mL with water R.<\/p>\n Plate\u00a0 TLC silica gel plate R.<\/p>\n Mobile phase ammonia R, water R, ethanol (96 per cent) R (2:30:68 V\/V\/V). Application 5 \u00b5L; allow to dry in air.<\/p>\n Development\u00a0 Over a path of 15 cm.<\/p>\n Drying\u00a0 In a current of warm air.<\/p>\n Detection\u00a0 Spray with ninhydrin solution R and heat at 100-105 \u00b0C for 15 min.<\/p>\n Limit:<\/p>\n \u2014 impurity B: any spot due to impurity B is not more intense than the corresponding spot in the chromatogram obtained with the reference solution (0.5 per cent).<\/p>\n Liquid chromatography (2.2.29).<\/p>\n Test solution (a) Dissolve 0.50 g of the substance to be examined in water R and dilute to 100.0 mL with the same solvent.<\/p>\n Test solution (b)\u00a0 To 20.0 mL of test solution (a), add 20 mL of the mobile phase and 0.4 mL of a 100 g\/L solution of phosphoric acid R, then dilute to 50.0 mL with the mobile phase.<\/p>\n Reference solution (a) Dissolve 40 mg of N-acetyl-\u03b5-caprolactam R (impurity C) in water R and dilute to 100.0 mL with the same solvent.<\/p>\n Reference solution (b)\u00a0 Dilute 5.0 mL of reference solution (a) to 100.0 mL with water R.<\/p>\n Reference solution (c) Dissolve 20 mg of zinc acexamate impurity A CRS in water R and dilute to 50.0 mL with the same solvent.<\/p>\n Reference solution (d) Dissolve 40 mg of \u03b5-caprolactam R (impurity D) in water R and dilute to 100.0 mL with the same solvent. Dilute 5.0 mL of this solution to 100.0 mL with water R.<\/p>\n Reference solution (e)\u00a0 To 20 mL of test solution (a), add 5 mL of reference solution (b), 5 mL of reference solution (c), 5 mL of reference solution (d) and 0.4 mL of a 100 g\/L solution of phosphoric acid R, then dilute to 50 mL with the mobile phase.<\/p>\n Reference solution (f) To 5.0 mL of reference solution (c), add 5.0 mL of reference solution (b), 5.0 mL of reference solution (d) and 0.4 mL of a 100 g\/L solution of phosphoric acid R, then dilute to 50.0 mL with the mobile phase.<\/p>\n Column:<\/p>\n \u2014 size: l = 0.25 m, \u00d8 = 4.0 mm;<\/p>\n \u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u00b5m).<\/p>\n Mobile phase Mix 0.2 volumes of phosphoric acid R, 8 volumes of acetonitrile R1 and 92 volumes of water for chromatography R, then adjust to pH 4.5 with dilute ammonia R1.<\/p>\n Flow rate\u00a0 1.2 mL\/min.<\/p>\n Detection\u00a0 Spectrophotometer at 210 nm.<\/p>\n Injection\u00a0 20 \u00b5L of test solution (b) and reference solutions (b), (e) and (f).<\/p>\n Run time\u00a0 8 times the retention time of zinc acexamate.<\/p>\n Elution order\u00a0 Zinc acexamate, impurity D, impurity A, impurity C.<\/p>\n System suitability\u00a0 Reference solution (e):<\/p>\n \u2014 resolution: minimum 3.0 between the peaks due to zinc acexamate and impurity D; if necessary, adjust the mobile phase to pH 4.7 with dilute ammonia R1.<\/p>\n Limits:<\/p>\n \u2014 impurity A: not more than the area of the corresponding peak in the chromatogram obtained with reference solution (f) (2 per cent);<\/p>\n \u2014 impurities C, D: for each impurity, not more than 1.5 times the area of the corresponding peak in the chromatogram obtained with reference solution (f) (0.15 per cent);<\/p>\n \u2014 unspecified impurities: for each impurity, not more than 0.5 times the area of the peak due to impurity C in the chromatogram obtained with reference solution (f) (0.05 per cent);<\/p>\n \u2014 sum of impurities other than A: not more than 5 times the area of the peak due to impurity C in the chromatogram obtained with reference solution (f) (0.5 per cent);<\/p>\n \u2014 disregard limit: 0.5 times the area of the peak due to impurity C in the chromatogram obtained with reference solution (f) (0.05 per cent).<\/p>\n Maximum 50 ppm.<\/p>\n Atomic absorption spectrometry (2.2.23, Method I).<\/p>\n Test solution Dissolve 1.25 g in 20 mL of a 200 g\/L solution of cadmium- and lead-free nitric acid R and dilute to 25.0 mL with the same acid solution.<\/p>\n Reference solutions Prepare the reference solutions using iron standard solution (20 ppm Fe) R, diluting with a 200 g\/L solution of cadmium- and lead-free nitric acid R.<\/p>\n Source\u00a0 Iron hollow-cathode lamp.<\/p>\n Wavelength\u00a0 248.3 nm.<\/p>\n Atomisation device\u00a0 Air-acetylene flame.<\/p>\n Loss on drying (2.2.32)<\/strong><\/p>\n Maximum 1.0 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<\/p>\n Dissolve 0.400 g in 10 mL of dilute acetic acid R. Carry out the complexometric titration of zinc (2.5.11). 1 mL of 0.1 M sodium edetate is equivalent to 40.98 mg of C16<\/sub>H28<\/sub>N2<\/sub>O6<\/sub>Zn.<\/p>\n In a non-metallic container.<\/p>\n Specified impurities\u00a0 A, B, C, D.<\/em><\/p>\n A. 6-(6-acetamidohexanamido)hexanoic acid,<\/p>\n B. 6-aminohexanoic acid (6-aminocaproic acid),<\/p>\n C. 1-acetylazepan-2-one (N-acetyl-\u03b5-caprolactam),<\/p>\n D. azepan-2-one (\u03b5-caprolactam).<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) DEFINITION Zinc bis(6-acetamidohexanoate). Content 97.5 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Soluble in water, practically insoluble in acetone and in ethanol (96 per cent). It dissolves in dilute nitric acid. mp About 198 \u00b0C. IDENTIFICATION A. Infrared…<\/p>\n","protected":false},"author":5,"featured_media":31877,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-31876","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\/31876","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=31876"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31876\/revisions"}],"predecessor-version":[{"id":31880,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31876\/revisions\/31880"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/31877"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=31876"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=31876"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=31876"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Solubility<\/h3>\n
mp<\/h3>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Solution S<\/h3>\n
Appearance of solution<\/h3>\n
Impurity B<\/h3>\n
Related substances<\/h3>\n
Iron<\/h3>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n