非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202104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250
标示量(mg)40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%
110.323945395394588839433633939785394005739428980.08
210.353971967397066539713160.03
单位质量响应值RSD%判断
382063.76383702.030.31数据可信
供试品溶液-2024011312批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13602792-360279284.68777.1810.7284.6977.1810.72
22730370-273037064.18064.18
33162865-316286574.34674.35
43619793-361979385.08785.09
53497061-349706182.20282.20
63088160-308816072.59072.59
10min14339717-4339717102.00999.844.41102.1599.974.41
23876920-387692091.13191.24
34243585-424358599.75099.87
44345769-4345769102.152102.29
54375688-4375688102.855102.99
64303129-4303129101.149101.27
15min14405307-4405307103.551102.611.40103.86102.911.42
24258083-4258083100.090100.35
34333452-4333452101.862102.15
44404671-4404671103.536103.85
54419015-4419015103.873104.18
64372099-4372099102.771103.06
20min14405349-4405349103.552103.070.67104.04103.530.69
24354992-4354992102.368102.79
34345180-4345180102.138102.60
44405538-4405538103.557104.04
54416246-4416246103.808104.29
64380893-4380893102.977103.44
30min14397591-4397591103.370103.170.43104.03103.810.44
24390132-4390132103.194103.79
34358288-4358288102.446103.08
44402999-4402999103.497104.15
54408906-4408906103.636104.29
64377472-4377472102.897103.53
45min14382179-4382179103.007102.910.44103.84103.720.44
24390868-4390868103.212103.98
34352403-4352403102.308103.11
44391673-4391673103.231104.06
54394263-4394263103.291104.12
64355968-4355968102.391103.20
60min14368414-4368414102.684102.690.46103.68103.670.46
24382901-4382901103.024103.96
34340577-4340577102.030103.00
44382228-4382228103.009104.01
54389333-4389333103.176104.18
64349452-4349452102.238103.21
极限14361958-4361958102.532102.920.69103.70104.070.69
24376763-4376763102.880103.99
34335511-4335511101.910103.05
44404785-4404785103.539104.71
54418793-4418793103.868105.04
64372270-4372270102.775103.92
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202104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250
标示量(mg)40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%
110.323985233398607739871663984406398152039848800.06
210.354006364400788340071240.03
单位质量响应值RSD%判断
386131.78387161.740.19数据可信
供试品溶液-2024011312批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13558942-355894282.84275.5612.2482.8475.5612.24
22858262-285826266.53266.53
33487423-348742381.17781.18
42792692-279269265.00665.01
53732078-373207886.87286.87
63046497-304649770.91470.91
10min14468505-4468505104.014100.182.81104.15100.302.82
24138479-413847996.33296.44
34325990-4325990100.697100.83
44254093-425409399.02399.13
54403969-4403969102.512102.66
64230913-423091398.48398.60
15min14525635-4525635105.344103.181.31105.66103.481.31
24400082-4400082102.421102.69
34398865-4398865102.393102.70
44482075-4482075104.330104.60
54412693-4412693102.715103.03
64377734-4377734101.901102.18
20min14533439-4533439105.525103.371.35106.01103.831.35
24402023-4402023102.466102.91
34401776-4401776102.461102.93
44498468-4498468104.711105.16
54412170-4412170102.703103.19
64396278-4396278102.333102.78
30min14517849-4517849105.162103.181.30105.83103.821.30
24396555-4396555102.339102.95
34398407-4398407102.382103.03
44493425-4493425104.594105.22
54406459-4406459102.570103.23
64383891-4383891102.044102.67
45min14507550-4507550104.923102.921.34105.76103.731.33
24388268-4388268102.146102.93
34386761-4386761102.111102.93
44485194-4485194104.402105.20
54393054-4393054102.258103.09
64368914-4368914101.696102.49
60min14501114-4501114104.773102.731.32105.79103.711.32
24383815-4383815102.043103.00
34378326-4378326101.915102.90
44473002-4473002104.119105.09
54378921-4378921101.929102.93
64365202-4365202101.609102.57
极限14485680-4485680104.414102.431.27105.60103.581.27
24362392-4362392101.544102.67
34366311-4366311101.635102.79
44456087-4456087103.725104.87
54375671-4375671101.853103.02
64356473-4356473101.406102.54
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202104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250
标示量(mg)40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%
110.323980553398087839627893957229395879039680480.30
210.354042550404415140433500.03
单位质量响应值RSD%判断
384500.78390661.841.13数据可信
供试品溶液-2024011312批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12303634-230363453.49648.2314.7753.5048.2314.77
22479039-247903957.56957.57
32195069-219506950.97550.97
41842892-184289242.79642.80
51651872-165187238.36038.36
61988789-198878946.18446.18
10min13618831-361883184.03883.904.9584.1383.984.95
23860486-386048689.65089.75
33793614-379361488.09788.18
43467814-346781480.53180.60
53505350-350535081.40381.47
63432088-343208879.70179.78
15min14082964-408296494.81694.871.6095.0595.101.61
24179165-417916597.05097.30
34137454-413745496.08296.31
44015500-401550093.25093.46
54080912-408091294.76994.97
64016277-401627793.26893.48
20min14258275-425827598.88798.380.8999.2798.760.90
24273861-427386199.24999.66
34238353-423835398.42598.82
44177622-417762297.01497.38
54206803-420680397.69298.05
64264991-426499199.04399.41
30min14318163-4318163100.27899.931.01100.83100.481.01
24323790-4323790100.409100.98
34290421-429042199.634100.19
44260268-426026898.93499.46
54257121-425712198.86199.38
64370375-4370375101.491102.02
45min14330845-4330845100.573100.230.93101.29100.940.93
24329859-4329859100.550101.29
34305671-430567199.988100.71
44276787-427678799.317100.00
54273186-427318699.23499.92
64379293-4379293101.698102.40
60min14329663-4329663100.545100.140.93101.43101.020.93
24328186-4328186100.511101.42
34299966-429996699.856100.74
44266189-426618999.07199.92
54275686-427568699.292100.14
64373626-4373626101.566102.44
极限14324211-4324211100.41999.970.83101.47101.010.83
24322593-4322593100.381101.46
34286566-428656699.544100.60
44270312-427031299.167100.19
54268671-426867199.129100.14
64356852-4356852101.177102.21
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202104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250
标示量(mg)40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%
110.324053309405613240567124051559405445740544340.06
210.354074944407400940744760.02
单位质量响应值RSD%判断
392871.51393669.180.15数据可信
供试品溶液-2024011312批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12648948-264894860.62151.4618.7860.6251.4618.78
22302899-230289952.70252.70
32504880-250488057.32457.32
42389263-238926354.67854.68
51448731-144873133.15433.15
62196585-219658550.26950.27
10min13954737-395473790.50484.998.0190.6185.088.02
23790641-379064186.74986.84
33811813-381181387.23487.33
43907332-390733289.41989.51
53139276-313927671.84271.90
63679449-367944984.20484.29
15min14207767-420776796.29594.133.6796.5594.363.69
24154152-415415295.06895.30
34163685-416368595.28695.53
44213984-421398496.43796.68
53812883-381288387.25887.43
64127786-412778694.46594.69
20min14289454-428945498.16497.231.6998.5897.611.71
24270845-427084597.73898.13
34251664-425166497.30097.70
44304971-430497198.51998.92
54107450-410745093.99994.32
64266558-426655897.64098.02
30min14338578-433857899.28998.880.5599.8699.430.57
24334904-433490499.20499.76
34292233-429223398.22898.79
44341287-434128799.35199.92
54290089-429008998.17998.66
64327286-432728699.03099.57
45min14344703-434470399.42999.030.63100.1799.740.62
24343567-434356799.403100.12
34298099-429809998.36299.09
44348973-434897399.526100.26
54339829-433982999.31799.96
64287754-428775498.12598.83
60min14339747-433974799.31599.090.40100.2299.970.39
24332648-433264899.153100.04
34295757-429575798.30999.20
44336928-433692899.251100.15
54340561-434056199.334100.14
64334574-433457499.197100.07
极限14343061-434306199.39198.950.47100.4699.990.46
24327650-432765099.038100.09
34284607-428460798.05399.11
44329561-432956199.082100.14
54327624-432762499.038100.01
64329433-432943399.079100.12
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