非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.133818002381995038214033816243381300938177210.09
210.063847294384702638471600.01
单位质量响应值RSD%判断
376872.75382421.471.04数据可信
供试品溶液-25022801批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11281718-128171830.38629.0511.3130.3929.0511.32
21051659-105165924.93224.93
31046133-104613324.80124.80
41351958-135195832.05232.05
51308927-130892731.03131.03
61312189-131218931.10931.11
10min12568238-256823860.88660.451.8960.9560.521.89
22484585-248458558.90358.96
32593043-259304361.47561.53
42607933-260793361.82861.90
52511438-251143859.54059.61
62534298-253429860.08260.15
15min12961110-296111070.20071.001.4270.4071.201.42
22957636-295763670.11870.30
33062666-306266672.60872.80
43031049-303104971.85972.07
52976214-297621470.55970.76
62980446-298044670.65970.86
20min13204324-320432475.96676.611.4376.3376.971.43
23182027-318202775.43875.78
33313541-331354178.55678.91
43251159-325115977.07777.45
53220363-322036376.34776.70
63218457-321845776.30276.66
30min13465028-346502882.14783.041.6482.6783.561.64
23442062-344206281.60382.11
33607384-360738485.52286.05
43506820-350682083.13883.68
53508244-350824483.17283.70
63485654-348565482.63683.17
45min13660677-366067786.78588.181.5587.5088.891.55
23674080-367408087.10387.79
33818547-381854790.52891.25
43740850-374085088.68689.41
53727897-372789788.37989.09
63693827-369382787.57188.28
60min13736231-373623188.57790.131.7289.4891.041.71
23762348-376234889.19690.08
33923910-392391093.02693.94
43804764-380476490.20191.12
53806044-380604490.23291.14
63778187-377818789.57190.48
极限13833900-383390090.89292.311.6591.9993.421.64
23858687-385868791.48092.56
34017854-401785495.25396.38
43882874-388287492.05393.18
53887457-388745792.16293.27
63881304-388130492.01693.12
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.133816201381669338186743819865381648638175840.05
210.063856331385892538576280.05
单位质量响应值RSD%判断
376859.23383462.031.23数据可信
供试品溶液-25022801批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1718074-71807417.00125.4517.6817.0025.4517.69
21033355-103335524.46624.47
31119625-111962526.50826.51
41131600-113160026.79226.79
51257655-125765529.77629.78
61188295-118829528.13428.13
10min12177248-217724851.54860.337.4751.5960.397.48
22528876-252887659.87459.93
32621309-262130962.06262.12
42624023-262402362.12662.19
52707075-270707564.09364.16
62630453-263045362.27962.34
15min12898826-289882668.63371.572.2168.7871.762.23
23020718-302071871.51871.71
33017659-301765971.44671.64
43059240-305924072.43172.63
53091459-309145973.19373.40
63049331-304933172.19672.40
20min13184913-318491375.40676.240.8775.7176.590.89
23222326-322232676.29276.64
33193722-319372275.61575.97
43231033-323103376.49876.86
53262779-326277977.25077.62
63225104-322510476.35876.72
30min13494531-349453182.73682.530.7383.2183.050.73
23487982-348798282.58183.10
33449243-344924381.66482.19
43484906-348490682.50983.04
53525373-352537383.46784.01
63471979-347197982.20382.73
45min13699191-369919187.58286.960.7588.2487.660.73
23678823-367882387.10087.80
33625722-362572285.84386.55
43679839-367983987.12487.84
53695358-369535887.49188.22
63658411-365841186.61687.33
60min13835657-383565790.81390.130.6091.6691.020.58
23790393-379039389.74190.63
33824200-382420090.54291.44
43797234-379723489.90390.81
53816740-381674090.36591.29
63775793-377579389.39690.30
极限13943755-394375593.37292.550.6894.4393.640.67
23910348-391034892.58193.67
33866694-386669491.54892.64
43907840-390784092.52293.63
53927372-392737292.98494.11
63896998-389699892.26593.37
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