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[求助]
紧急求助，关于API原料药GC、HPLC分析的几道英文题，请高人帮忙解答，重谢！！
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紧急作业，关系前途，请高手能不吝赐教和帮助！！！请帮忙解答下，最好是用英文，英文麻烦的话，用中文解答就可以，后面我再翻译一下，谢谢谢谢！ 1. You should check suitability of HPLC or/and GC systems before to perform Assay or/and Residual Solvent tests respectively. Please list principal parameters of checking and argue. 2.You have to perform Related Substance test with HPLC in case of absence of related substance standards. Please specify your solution and argue. 3. 见附件（有图） 4.You have chromatograms of mobile phase, solvent, placebo, standard and sample of tablets for Related Substance test. Please explain the purpose each of them. 5.You should perform Identification test for API. Please list the methods you have to use for API in cases of presence and absence of reference standard separately. 6.Please make up a list of parameters that must be included to the specification for API. 7.Please make up a list of parameters that must be included to the specification for film-coated tablets with 0.5 mg strength. 8.Please see below the quotation from Dissolution Test. “Preparation of test solution. Transfer 1 tablet with 1 mg strength into 1000 ml vessel. After 30 minutes filter the solution through membrane filter with pore size not more than 0.45 μm. Preparation of standard solution. Transfer 25 mg of reference standard into 50 ml volumetric flask, add 10 ml of diluent, mix until complete dissolution. Dilute to the volume with diluent, mix. Transfer 1 ml of obtained solution into 50 ml volumetric flask, dilute to the volume with diluent, mix. Transfer 5 ml of obtained solution into 10 ml volumetric flask, dilute to the volume with diluent, mix. The amount released in dissolution medium is determined with HPLC method.” Please calculate the amount released in dissolution medium in %, assuming the principal peak area on the chromatograms obtained with test solution is 20 and principal peak area on the chromatogram obtained with standard solution is 120. 9.Is it possible to predict the order of retention for Toluene, Ethanol, 2-Propanol, Methanol, Ethyl Acetate, Tetrahydrofuran on GC capillary column coated with DB-624 (6 % cyanopropylphenyl, 94 % dimethylpolysiloxane)? Please argue. 10.Can you calculate the retention index of unknown compound if you know (after GC analysis), that the retention time of hexane is 5.4, the retention time of heptane is 7.8, the retention time of unknown compound is 6.2? Can you assume what compound can it be? 11.How to calculate resolution between two peaks? 12.The resolution 0,8 between two peaks is enough? 13、 14 见附件（有图）。 |
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2013-08-15 22:32:51, 172.31 K
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