非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.373884473882023889183888883882433885400.09
211.353898683898143898410.01
单位质量响应值RSD%判断
34172.3834347.220.37数据可信
供试品溶液-BXK0LE1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17169-71699.40910.2922.489.4110.2922.47
211034-1103414.48214.48
37033-70339.2309.23
47640-764010.02710.03
58299-829910.89210.89
65852-58527.6807.68
10min135991-3599147.23637.2916.6047.2937.3416.58
228149-2814936.94437.02
322675-2267529.76029.81
429573-2957338.81338.87
529833-2983339.15439.21
624241-2424131.81531.86
15min145010-4501059.07349.4813.2659.3949.7513.27
238150-3815050.07050.36
331084-3108440.79641.01
439234-3923451.49351.76
539663-3966352.05652.33
633081-3308143.41743.64
20min151586-5158667.70456.8813.0168.3557.4113.02
244405-4440558.27958.84
335454-3545446.53246.97
444091-4409157.86758.42
545743-4574360.03560.60
638739-3873950.84351.30
30min158613-5861376.92767.4210.6377.9568.2710.67
252302-5230268.64469.53
343455-4345557.03357.73
452478-5247868.87569.75
554600-5460071.66072.56
646747-4674761.35362.10
45min163893-6389383.85678.445.7085.3079.675.80
260081-6008178.85380.12
355497-5549772.83773.86
461349-6134980.51881.78
561917-6191781.26382.56
655847-5584773.29674.38
60min168381-6838189.74784.585.9491.6686.256.02
264550-6455084.71986.43
358324-5832476.54777.97
465921-6592186.51888.23
567735-6773588.89990.65
661767-6176781.06682.56
90min173035-7303595.85591.893.9798.2794.024.09
269683-6968391.45593.63
365779-6577986.33288.18
471476-7147693.80996.00
572199-7219994.75897.00
667903-6790389.11991.06
极限173458-7345896.41094.902.9699.3597.543.09
273520-7352096.49199.18
368633-6863390.07792.41
473976-7397697.09099.80
573486-7348696.44799.22
670764-7076492.87495.31
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.371944231944011945751948991949591946510.14
211.351955311954151954730.05
单位质量响应值RSD%判断
17119.7017222.290.43数据可信
供试品溶液-BXK3152批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14916-491612.87316.2338.4112.8716.2338.43
211028-1102828.87828.88
35539-553914.50514.50
44972-497213.02013.02
55208-520813.63813.64
65527-552714.47314.47
10min113535-1353535.44341.0733.4635.5141.1633.47
226347-2634768.99369.15
314325-1432537.51237.59
412844-1284433.63433.71
513842-1384236.24736.32
613219-1321934.61634.70
15min118532-1853248.52855.5925.5348.8055.9025.59
232171-3217184.24484.79
319692-1969251.56651.85
418375-1837548.11748.38
520264-2026453.06453.34
618331-1833148.00248.27
20min120959-2095954.88462.6522.2955.4263.2722.37
234663-3466390.76991.78
322373-2237358.58759.16
421122-2112255.31155.84
523195-2319560.73961.31
621230-2123055.59356.13
30min125425-2542566.57972.8215.0967.4273.7915.25
236160-3616094.68996.21
326896-2689670.43171.33
425111-2511165.75666.59
527522-2752272.07072.98
625728-2572867.37268.22
45min129955-2995578.44183.5210.6279.6584.9010.83
238409-38409100.579102.62
330911-3091180.94482.24
430468-3046879.78480.98
532524-3252485.16886.48
629111-2911176.23177.45
60min133896-3389688.76190.456.0590.4192.306.29
237997-3799799.500102.10
333388-3338887.43189.17
433208-3320886.95988.60
536156-3615694.67996.46
632611-3261185.39687.04
90min136654-3665495.98396.511.4298.1298.861.72
237650-3765098.591101.74
336098-3609894.52796.75
436797-3679796.35898.48
537188-3718897.38199.69
636755-3675596.24898.37
极限136501-3650195.58298.341.6398.26101.221.87
238251-38251100.165103.87
337434-3743498.026100.78
437709-3770998.746101.41
538012-3801299.539102.39
637410-3741097.963100.62
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