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Alpha Tocopheryl Succinate Tablets
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 α-tocopherol, C29H50O2|
95.0 to 105.0% of the stated amount.
A. Carry out the method for thin-layer chromatography, Appendix III A, using silica gel HF254 as the coating substance and a mixture of 20 volumes of ether and 80 volumes of cyclohexane as the mobile phase. Apply separately to the plate 10 µl of each of the following solutions. For solution (1) shake a quantity of the powdered tablets containing the equivalent of 0.134 g of α-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. For solution (2) dissolve 10 mg of the residue obtained in the preparation of solution (1) in 2 ml of 5m ethanolic sulphuric acid, heat in a water bath for 1 minute, cool, add 2 ml each of water and cyclohexane and shake for 1 minute; use the upper layer. Solution (3) contains 0.5% w/v of RRR-α-tocopheryl succinate EPCRS in cyclohexane. Prepare solution (4) in the same manner as solution (2) but using 10 mg of RRR-α-tocopheryl succinate EPCRS in place of the substance being examined.
After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm). 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). There are two spots in each of the chromato-grams obtained with solutions (2) and (4). 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 α-tocopherol, is orange.
B. In 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).
Carry out the method for thin-layer chromatography, Appendix III A, using silica gel HF254 as the coating substance and a mixture of 20 volumes of ether and 80 volumes of cyclohexane as the mobile phase. Apply separately to the plate 10 µl of each of the following solutions. For solution (1) shake a quantity of the powdered tablets containing the equivalent of 134 mg of α-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. Solution (2) contains 0.005% w/v of α-tocopherol EPCRS in cyclohexane. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm). 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%).
Carry out the method for gas chromatography, Appendix III B, using the following solutions. Dissolve 0.15 g of dotriacontane (internal standard) in sufficient hexane to produce 100 ml (solution A). For solution (1) mix a quantity of the powdered tablets containing the equivalent of 134 mg of α-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. For solution (2) dissolve 0.165 g of RRR-α-tocopheryl succinate EPCRS in 20 ml of methanol and continue in the same manner as solution (1) using 4 ml and beginning at the words 'add 2 ml of 2,2-dimethoxy-propane...'.
The chromatographic procedure may be carried out using a borosilicate glass column (2 m × 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. Set the temperature of the column and the rate of flow of carrier gas at values such that the required resolution is achieved (a column temperature of 280° and a rate of flow of carrier gas of 40 ml per minute are suitable). Maintain the temperature of the injection port at 290° and the detector at 350°. The retention times of dotriacontane and methyl α-tocopheryl succinate (obtained in solution (1)) are about 8 minutes and 20 minutes, respectively.
Calculate the content of C29H50O2 from the areas of the peaks due to dotriacontane and methyl α-tocopheryl succinate in the chromatograms obtained with solution (1) and solution (2) and from the declared content of C29H50O2 in RRR-α-tocopheryl succinate EPCRS.
Alpha Tocopheryl Succinate Tablets should be protected from light.
|Labelling||The quantity of active ingredient is stated in terms of the equivalent amount of α-tocopherol.|
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Dideu Industries is one of the largest producer for general chemical, pharmaceutical, nutrition additive, natural extracts, agrochemical and Daily-Use Chemical in China and is headquartered in Shaanxi, China. The Dideu Group comprises subsidiaries and joint ventures in more than 10 countries and operates six integrated production sites and 21 other production sites in Europe, Asia, Australia, Americas and Africa.Its headquarters is located in Xi’An,China. Dideu has customers in over 200 countries and supplies products to a wide variety of industries.
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