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fchg007木虫 (正式写手)
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[求助]
丙硫硫胺的质量标准，美国药典，日本药典
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丙硫硫胺的质量标准，美国药典，日本药典，请详细列出，不胜感激！ |
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【答案】应助回帖
★
jiangchunyong(金币+1): 谢谢 2011-08-02 21:46:59
fchg007(金币+10): 2011-08-04 11:02:48
fchg007(金币+5): 2011-09-06 15:33:25
jiangchunyong(金币+1): 谢谢 2011-08-02 21:46:59
fchg007(金币+10): 2011-08-04 11:02:48
fchg007(金币+5): 2011-09-06 15:33:25
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Assay— Solution A— Prepare a 0.005 M solution of sodium 1-octanesulfonate in dilute glacial acetic acid (1 in 100). Solution B— Prepare a mixture of methanol and acetonitrile (3:2). Mobile phase— Prepare a mixture of Solution A and Solution B (60:40), filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621). Internal standard solution— Transfer 2.0 mL of methylbenzoate to a 100-mL volumetric flask, dilute with methanol to volume, and mix. Standard preparation— Dissolve an accurately weighed quantity of USP Thiamine Hydrochloride RS in Mobile phase to obtain a solution having a known concentration of about 1 mg per mL. Transfer 20.0 mL of this solution to a 50-mL volumetric flask, add 5.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix to obtain a Standard preparation having a known concentration of about 400 µg per mL. Assay preparation— Transfer an accurately weighed quantity of about 200 mg of Thiamine Hydrochloride to a 100-mL volumetric flask, dissolve in and dilute with Mobile phase to volume, and mix. Transfer 10.0 mL of this solution to a 50-mL volumetric flask, add 5.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix. Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 254-nm detector and a 4-mm × 30-cm column that contains packing L1. The flow rate is about 1 mL per minute. [note—The flow rate may be adjusted as needed to obtain a retention time of about 12 minutes for thiamine hydrochloride. ] Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between the thiamine and methylbenzoate peaks is not less than 4.0; the tailing factor for the thiamine peak is not more than 2.0; the column efficiency determined from the thiamine peak is not less than 1500 theoretical plates; and the relative standard deviation for replicate injections is not more than 2.0%. Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the areas of the major peaks. Calculate the quantity, in mg, of C12H17ClN4OS·HCl in the Thiamine Hydrochloride taken by the formula: 0.5C(RU / RS) in which C is the concentration, in µg per mL, of USP Thiamine Hydrochloride RS in the Standard preparation; and RU and RS are the ratios of the peak areas of thiamine to methylbenzoate obtained from the Assay preparation and the Standard preparation, respectively. Auxiliary Information— Please check for your question in the FAQs before contacting USP. Topic/Question Contact Expert Committee Monograph Huy T. Dinh, M.S. Scientific Liaison 1-301-816-8594 (DS2010) Monographs - Dietary Supplements Reference Standards RS Technical Services 1-301-816-8129 rstech@usp.org USP34–NF29 Page 4408 |
2楼2011-08-02 15:41:46