Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Alpha Tocopheryl Succinate Tablets<\/p>\n
General Notices<\/p>\n
Alpha Tocopheryl Succinate Tablets contain RRR-Alpha-Tocopheryl Hydrogen Succinate. They are coated. The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n
Content of \u03b1-tocopherol, C29<\/sub>H50<\/sub>O2<\/sub><\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n A.\u2003Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions. (1)\u2003Shake a quantity of the powdered tablets containing the equivalent of 0.134 g of \u03b1-tocopherol with three 10 mL quantities of ether, filter, evaporate the combined filtrates to 2 mL and then evaporate the solution to dryness under a current of nitrogen. Prepare a 0.5% w\/v solution from a portion of the resulting residue in cyclohexane. (2)\u2003Dissolve 10 mg of the residue obtained in the preparation of solution (1) in 2 mL of 5M ethanolic sulfuric acid, heat in a water bath for 1 minute, cool and add 2 mL each of water and cyclohexane. Shake for 1 minute, allow to separate and use the upper layer.<\/p>\n (3)\u20030.5% w\/v of RRR-\u03b1-tocopheryl succinate EPCRS in cyclohexane.<\/p>\n (4)\u2003Prepare in the same manner as solution (2) but using 10 mg of RRR-\u03b1-tocopheryl succinate EPCRS in place of the substance being examined.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n (a)\u2003Use as the coating silica gel F254.<\/p>\n (b)\u2003Use the mobile phase as described below.<\/p>\n (c)\u2003Apply 10 \u00b5L of each solution.<\/p>\n (d)\u2003Develop the plate to 15 cm.<\/p>\n (e)\u2003After removal of the plate, dry in air and examine under ultraviolet light (254 nm).<\/p>\n MOBILE PHASE<\/p>\n 20 volumes of ether and 80 volumes of cyclohexane.<\/p>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless the chromatograms obtained with solutions (2) and (4) show two clearly separated spots.<\/p>\n CONFIRMATION<\/p>\n The principal spot in the chromatogram obtained with solution (1) is similar in position and size to that in the chromatogram obtained with solution (3).<\/p>\n Spray the plate with a mixture of 1 volume of hydrochloric acid, 4 volumes of a 0.25% w\/v solution of iron (III) chloride hexahydrate in ethanol (96%) and 4 volumes of a 1% w\/v solution of 1,10-phenanthroline hydrochloride in ethanol (96%). In the chromatograms obtained with solutions (2) and (4) the spot of higher Rf value, due to \u03b1-tocopherol, is orange.<\/p>\n B.\u2003In the Assay the principal peak in the chromatogram obtained with solution (1) shows a peak with the same retention time as the peak due to the methylated alpha tocopheryl succinate in the chromatogram obtained with solution (2).<\/p>\n Free tocopherol<\/strong><\/p>\n Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n (1)\u2003Shake a quantity of the powdered tablets containing the equivalent of 134 mg of \u03b1-tocopherol with three 10 mL quantities of ether, filter and evaporate the combined filtrates to 2 mL, evaporate the final solution to dryness under a current of nitrogen and prepare a 0.5% w\/v solution from the resulting residue in cyclohexane. (2)\u20030.005% w\/v of \u03b1-tocopherol BPCRS in cyclohexane.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n (a)\u2003Use as the coating silica gel HF254 as the coating substance.<\/p>\n (b)\u2003Use the mobile phase as described below.<\/p>\n (c)\u2003Apply 10 \u00b5L of each solution.<\/p>\n (d)\u2003Develop the plate to 15 cm.<\/p>\n (e)\u2003After removal of the plate, dry in air and examine under ultraviolet light (254 nm).<\/p>\n MOBILE PHASE<\/p>\n 20 volumes of ether and 80 volumes of cyclohexane.<\/p>\n LIMITS<\/p>\n Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the principal spot in the chromatogram obtained with solution (2) (1%).<\/p>\n Carry out the method for gas chromatography, Appendix III B. Dissolve 0.15 g of dotriacontane (internal standard) in sufficient hexane to produce 100 mL (solution A).<\/p>\n (1)\u2003Mix a quantity of the powdered tablets containing the equivalent of 134 mg of \u03b1-tocopherol with 20 mL of methanol, mix with the aid of ultrasound for 5 minutes and centrifuge for 15 minutes. To 4 mL of the clear supernatant liquid add 2 mL of 2,2-dimethoxypropane and 0.2 mL of hydrochloric acid and allow to stand in the dark at room temperature for 1 hour. Evaporate to dryness on a water bath with the aid of a current of nitrogen and dissolve the residue in 10 mL of solution A. (2)\u2003Dissolve 0.165 g of RRR-\u03b1-tocopheryl succinate EPCRS in 20 mL of methanol, add 2 mL of 2,2-dimethoxypropane and 0.2 mL of hydrochloric acid and allow to stand in the dark at room temperature for 1 hour. Evaporate to dryness on a water bath with the aid of a current of nitrogen and dissolve the residue in 10 mL of solution A.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n (a)\u2003Use a borosilicate glass column (2 m \u00d7 4 mm) packed with acid-washed, silanised diatomaceous support (100 to 120 mesh) (Chromosorb W\/AW is suitable) coated with 2 to 5% of polymethylsiloxane.<\/p>\n (b)\u2003Use a rate of flow of carrier gas at values such that the required resolution is achieved (40 mL per minute is suitable). (c)\u2003Set the temperature of the column such that the required resolution is achieved (a column temperature of 280\u00b0 is suitable).<\/p>\n (d)\u2003Maintain the temperature of the injection port at 290\u00b0 and the detector at 350\u00b0.<\/p>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (1), the retention times of dotriacontane and methyl \u03b1-tocopheryl succinate are about 8 minutes and 20 minutes, respectively.<\/p>\n DETERMINATION OF CONTENT<\/p>\n Calculate the content of C29<\/sub>H50<\/sub>O2<\/sub> from the areas of the peaks due to dotriacontane and methyl \u03b1-tocopheryl succinate in the chromatograms obtained with solution (1) and solution (2) and from the declared content of C29<\/sub>H50<\/sub>O2<\/sub> in RRR-\u03b1 tocopheryl succinate EPCRS.<\/p>\n Alpha Tocopheryl Succinate Tablets should be protected from light.<\/p>\n The quantity of active ingredient is stated in terms of the equivalent amount of \u03b1-tocopherol.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Alpha Tocopheryl Succinate Tablets General Notices DEFINITION Alpha Tocopheryl Succinate Tablets contain RRR-Alpha-Tocopheryl Hydrogen Succinate. They are coated. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of \u03b1-tocopherol, C29H50O2 95.0 to 105.0% of the stated amount. IDENTIFICATION A.\u2003Carry out the method…<\/p>\n","protected":false},"author":5,"featured_media":2920,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-2907","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/2907","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=2907"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/2907\/revisions"}],"predecessor-version":[{"id":6556,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/2907\/revisions\/6556"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/2920"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=2907"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=2907"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=2907"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
LABELLING<\/h2>\n