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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.151933877192653219305971930095193230619306810.15
210.191954609195493219547700.02
单位质量响应值RSD%判断
190214.88191832.190.60数据可信
供试品溶液-2024092212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%
5min1644794-64479430.38027.8619.6530.3827.8619.65
2654038-65403830.81530.82
3627857-62785729.58229.58
4637973-63797330.05830.06
5627643-62764329.57229.57
6355022-35502216.72716.73
10min11370134-137013464.55461.417.2964.6261.477.30
21322906-132290662.32962.40
31322503-132250362.31062.38
41344017-134401763.32463.39
51347678-134767863.49663.56
61113028-111302852.44152.48
15min11647706-164770677.63275.253.1277.8475.453.14
21594627-159462775.13275.34
31591466-159146674.98375.19
41633844-163384476.97977.19
51609245-160924575.82076.03
61505920-150592070.95271.11
20min11769552-176955283.37382.121.6383.7682.491.65
21721245-172124581.09781.47
31734502-173450281.72282.09
41779501-177950183.84284.22
51747842-174784282.35082.73
61705463-170546380.35480.67
30min11897895-189789589.42088.631.3489.9989.181.33
21845064-184506486.93187.49
31864480-186448087.84688.40
41916351-191635190.29090.85
51885455-188545588.83489.39
61877579-187757988.46388.95
45min11979166-197916693.24993.131.2694.0293.871.25
21937565-193756591.28992.04
31964022-196402292.53693.28
42012427-201242794.81695.58
51978736-197873693.22993.98
61987540-198754093.64494.33
60min12020163-202016395.18195.071.2596.1696.021.25
21978190-197819093.20394.15
32004667-200466794.45195.40
42052731-205273196.71597.69
52018756-201875695.11596.08
62032391-203239195.75796.65
极限12050204-205020496.59696.391.1297.7897.561.12
22005590-200559094.49495.65
32039075-203907596.07297.24
42073984-207398497.71798.91
52049032-204903296.54197.72
62057526-205752696.94198.05
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.151938944194121919433871943590194286419420010.11
210.191932181193100019315900.05
单位质量响应值RSD%判断
191330.15189557.410.66数据可信
供试品溶液-2024092212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%
5min1642286-64228630.35424.4828.7630.3524.4828.76
2688306-68830632.52932.53
3386636-38663618.27218.27
4568789-56878926.88026.88
5301964-30196414.27114.27
6520160-52016024.58224.58
10min11311229-131122961.96756.0311.8462.0356.0811.85
21305971-130597161.71961.79
31060347-106034750.11150.15
41283714-128371460.66760.73
5979015-97901546.26746.30
61173122-117312255.44155.50
15min11579637-157963774.65272.084.2674.8672.264.29
21572206-157220674.30174.51
31476501-147650169.77869.93
41574837-157483774.42574.62
51420230-142023067.11967.25
61527975-152797572.21172.39
20min11718030-171803081.19280.061.8581.5680.391.88
21712492-171249280.93181.31
31652498-165249878.09678.40
41714248-171424881.01481.37
51655098-165509878.21878.50
61711440-171144080.88181.22
30min11858900-185890087.85087.461.0188.4087.981.03
21866014-186601488.18688.74
31816551-181655185.84986.33
41847847-184784787.32887.87
51848796-184879687.37287.83
61866361-186636188.20288.72
45min11958386-195838692.55192.071.0193.3092.791.01
21956366-195636692.45693.21
31913413-191341390.42691.10
41937473-193747391.56392.30
51965982-196598292.91093.56
61958138-195813892.54093.25
60min12000256-200025694.53094.160.9895.4895.070.97
21999897-199989794.51395.47
31962352-196235292.73993.61
41977111-197711193.43694.37
52016678-201667895.30696.16
61997830-199783094.41695.34
极限12037139-203713996.27395.481.1397.4496.611.12
22028534-202853495.86797.03
31986080-198608093.86094.94
41998889-199888994.46695.61
52043201-204320196.56097.63
62028368-202836895.85996.99
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.151945809194662019459061945122194454619456010.05
210.191991840199195219918960.01
单位质量响应值RSD%判断
191684.83195475.561.39数据可信
供试品溶液-2024092213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%
5min1520042-52004224.18026.0122.8224.1826.0222.81
2333936-33393615.52715.53
3702424-70242432.66032.66
4551354-55135425.63625.64
5618690-61869028.76728.77
6630332-63033229.30829.31
10min11226093-122609357.00957.7210.6757.0657.7810.68
21000832-100083246.53646.57
31347113-134711362.63662.71
41207402-120740256.14056.20
51345652-134565262.56962.63
61321101-132110161.42761.49
15min11510145-151014570.21772.175.0370.4072.355.05
21428861-142886166.43766.58
31615016-161501675.09375.30
41523559-152355970.84171.02
51626824-162682475.64275.85
61607988-160798874.76674.97
20min11655225-165522576.96379.333.2977.3079.683.32
21633347-163334775.94576.23
31743681-174368181.07681.45
41684279-168427978.31478.65
51767584-176758482.18782.56
61752703-175270381.49581.86
30min11796837-179683783.54786.152.4884.0586.672.50
21806769-180676984.00984.46
31872647-187264787.07287.63
41838936-183893685.50586.02
51905540-190554088.60289.16
61895922-189592288.15488.70
45min11900487-190048788.36790.782.1589.0691.502.17
21915256-191525689.05389.69
31967166-196716691.46792.22
41936129-193612990.02490.73
52003372-200337293.15093.90
61992303-199230392.63693.38
60min11946548-194654890.50892.892.0591.4093.802.07
21965144-196514491.37392.21
32012981-201298193.59794.55
41977462-197746291.94692.85
52048162-204816295.23396.19
62035904-203590494.66395.61
极限11979619-197961992.04694.171.8293.1495.301.84
21996579-199657992.83593.88
32040726-204072694.88796.05
42005698-200569893.25994.37
52071487-207148796.31897.49
62058263-205826395.70396.86
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.151972006196948019685751966704196093119675390.22
210.191939038193999219395150.04
单位质量响应值RSD%判断
193846.21190335.131.30数据可信
供试品溶液-2024092213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%
5min1365850-36585017.14317.5239.7117.1417.5239.72
2574760-57476026.93126.93
3527705-52770524.72724.73
4198336-1983369.2939.29
5307383-30738314.40314.40
6269499-26949912.62812.63
10min11051513-105151349.27149.2310.8449.3149.2710.87
21208088-120808856.60756.67
31162922-116292254.49154.55
4916539-91653942.94642.97
5990840-99084046.42846.46
6973991-97399145.63845.67
15min11462725-146272568.53968.564.0468.6968.714.07
21559222-155922273.06073.25
31494633-149463370.03470.21
41388547-138854765.06365.18
51448435-144843567.86968.00
61425186-142518666.78066.91
20min11664390-166439077.98877.582.0478.2977.882.07
21712935-171293580.26380.61
31661130-166113077.83578.17
41613044-161304475.58275.84
51647105-164710577.17877.46
61635610-163561076.63976.92
30min11847871-184787186.58585.871.1087.0686.341.12
21865026-186502687.38987.92
31815329-181532985.06085.57
41814406-181440685.01785.45
51826708-182670885.59486.05
61825788-182578885.55186.00
45min11956982-195698291.69890.920.9892.3691.580.99
21968601-196860192.24292.96
31917129-191712989.83190.52
41932228-193222890.53891.16
51934654-193465490.65291.30
61932273-193227390.54091.18
60min12005266-200526693.96093.241.0794.8394.111.08
22022647-202264794.77595.70
31962128-196212891.93992.83
41987059-198705993.10793.93
51980552-198055292.80293.65
61981905-198190592.86693.71
极限12034268-203426895.31994.551.1396.4095.621.14
22054016-205401696.24597.38
31991365-199136593.30994.41
42013046-201304694.32595.35
52001335-200133593.77694.83
62013059-201305994.32595.37
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