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)10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%
19.651822089182098418204731821870182018418211200.05
29.711850751184945418501020.05
单位质量响应值RSD%判断
188717.10190535.740.68数据可信
供试品溶液-2024112321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%
5min1394371-39437137.43638.367.2337.4438.367.23
2392029-39202937.21437.21
3429566-42956640.77740.78
4355964-35596433.79033.79
5420662-42066239.93239.93
6431995-43199541.00741.01
10min1688306-68830665.33865.331.3265.4265.411.33
2682220-68222064.76064.84
3698900-69890066.34466.43
4673630-67363063.94564.02
5692884-69288465.77265.86
6693153-69315365.79865.89
15min1803543-80354376.27776.280.5676.5176.510.57
2799054-79905475.85176.08
3808890-80889076.78477.02
4800363-80036375.97576.19
5800220-80022075.96176.20
6809083-80908376.80377.04
20min1861633-86163381.79182.120.6482.1982.520.64
2864035-86403582.01982.41
3867420-86742082.34082.75
4865103-86510382.12082.51
5858079-85807981.45481.86
6874162-87416282.98083.39
30min1919278-91927887.26388.660.9987.8489.240.99
2933431-93343188.60789.18
3932741-93274188.54189.13
4946088-94608889.80890.38
5931267-93126788.40188.99
6941200-94120089.34489.94
45min11004031-100403195.30893.921.0196.0894.701.00
2979696-97969692.99893.77
3981570-98157093.17693.96
4996599-99659994.60395.37
5981526-98152693.17293.95
6993062-99306294.26795.06
60min11018831-101883196.71396.231.0797.7097.221.06
21002338-100233895.14896.13
31011087-101108795.97896.97
41028174-102817497.60098.58
51001215-100121595.04196.03
61020872-102087296.90797.91
极限11032331-103233197.99597.890.9799.1999.100.96
21019252-101925296.75397.95
31030155-103015597.78899.00
41043065-104306599.014100.21
51021202-102120296.93898.14
61041562-104156298.871100.09
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)10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%
19.651833158183384618300101827107182175718291760.28
29.711872575187383118732030.05
单位质量响应值RSD%判断
189551.92192914.831.25数据可信
供试品溶液-b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%
5min1432734-43273440.73535.4315.6740.7335.4315.67
2459091-45909143.21643.22
3346856-34685632.65132.65
4328580-32858030.93030.93
5379706-37970635.74335.74
6311571-31157129.32929.33
10min1685840-68584064.56062.442.4364.6562.522.44
2681553-68155364.15764.25
3653321-65332161.49961.57
4655680-65568061.72161.79
5647866-64786660.98661.07
6655524-65552461.70761.77
15min1798711-79871175.18574.081.6575.4274.301.66
2797852-79785275.10475.34
3788589-78858974.23274.44
4793028-79302874.65074.86
5778187-77818773.25373.47
6765509-76550972.06072.26
20min1866986-86698681.61280.321.5482.0180.701.54
2858636-85863680.82681.23
3850230-85023080.03580.41
4866013-86601381.52081.89
5843842-84384279.43379.81
6833903-83390378.49878.86
30min1935381-93538188.05087.411.3288.6387.971.32
2925515-92551587.12287.71
3922193-92219386.80987.36
4946662-94666289.11289.67
5930733-93073387.61388.17
6910830-91083085.73986.28
45min1985759-98575992.79393.563.0593.5794.313.03
21040129-104012997.91198.69
31006332-100633294.72995.47
41004472-100447294.55495.31
5973718-97371891.65992.41
6952776-95277689.68890.42
60min11034159-103415997.34994.941.9198.3395.901.90
21001131-100113194.24095.24
31007243-100724394.81595.77
41028777-102877796.84297.80
5993816-99381693.55194.50
6986248-98624892.83993.77
极限11021029-102102996.11396.201.6697.3197.381.64
21015389-101538995.58296.79
31032337-103233797.17798.34
41049891-104989198.830100.01
51010039-101003995.07896.24
61003317-100331794.44595.58
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)10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%
19.651847351184726118469271846794184668018470030.02
29.711857877185767418577760.01
单位质量响应值RSD%判断
191399.27191326.060.03数据可信
供试品溶液-2024112321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%
5min1373432-37343235.12635.8222.5835.1335.8222.58
2525937-52593749.47149.47
3308509-30850929.01929.02
4331164-33116431.15031.15
5309462-30946229.10929.11
6436138-43613841.02441.02
10min1678032-67803263.77763.465.8063.8663.545.82
2738033-73803369.42169.53
3667174-66717462.75662.82
4654356-65435661.55061.62
5620522-62052258.36858.43
6689531-68953164.85964.95
15min1810138-81013876.20376.134.2876.4276.354.29
2835741-83574178.61278.88
3795595-79559574.83575.04
4778332-77833273.21273.42
5773485-77348572.75672.95
6862627-86262781.14181.38
20min1878664-87866482.64982.631.7883.0483.021.81
2893239-89323984.02084.46
3869640-86964081.80082.17
4865761-86576181.43581.80
5862622-86262281.14081.50
6900904-90090484.74185.16
30min1960446-96044690.34290.031.6890.9190.601.69
2968699-96869991.11891.74
3960717-96071790.36790.92
4928611-92861187.34787.90
5950785-95078589.43389.97
6973653-97365391.58492.19
45min11016403-101640395.60594.561.2196.3895.341.21
21017214-101721495.68196.51
31001450-100145094.19994.95
4990606-99060693.17993.92
51013763-101376395.35796.09
6992416-99241693.34994.16
60min11037793-103779397.61796.761.2398.6097.741.24
21038907-103890797.72298.76
31022832-102283296.21097.17
41006069-100606994.63395.58
51036176-103617697.46598.41
61030137-103013796.89797.91
极限11050315-105031598.79598.181.47100.0099.381.46
21055261-105526199.260100.52
31037216-103721697.56398.74
41021815-102181596.11497.28
51063393-1063393100.025101.19
61034358-103435897.29498.52
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)10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%
19.651856125185599118596451857488185819318574880.09
29.711868732186869918687160.01
单位质量响应值RSD%判断
192485.80192452.730.02数据可信
供试品溶液-b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%
5min1438226-43822640.98434.2016.0840.9834.2016.08
2339703-33970331.77031.77
3345460-34546032.30832.31
4441215-44121541.26341.26
5319642-31964229.89329.89
6309868-30986828.97928.98
10min1711665-71166566.55662.374.5266.6562.444.54
2644950-64495060.31760.39
3660059-66005961.73061.80
4695667-69566765.06065.15
5653731-65373161.13861.20
6635257-63525759.41059.47
15min1862469-86246980.65974.654.5080.9074.874.51
2792659-79265974.13174.34
3765592-76559271.59971.81
4814655-81465576.18876.42
5782044-78204473.13873.34
6772128-77212872.21172.41
20min1887163-88716382.96980.902.3083.3981.282.32
2848478-84847879.35179.72
3877966-87796682.10982.48
4882985-88298582.57882.98
5851984-85198479.67980.04
6841703-84170378.71779.07
30min1971617-97161790.86788.541.4091.4789.101.42
2934293-93429387.37687.92
3940295-94029587.93888.49
4949652-94965288.81389.40
5944495-94449588.33188.87
6939917-93991787.90288.43
45min11004444-100444493.93793.702.0794.7494.452.07
2999199-99919993.44794.19
31037469-103746997.02697.77
41005922-100592294.07594.86
5976308-97630891.30692.04
6987809-98780992.38193.11
60min11033604-103360496.66495.041.6897.6896.011.68
2994645-99464593.02193.97
31010106-101010694.46795.43
41035816-103581696.87197.87
51001459-100145993.65894.60
61022055-102205595.58496.52
极限11039411-103941197.20796.801.8398.4497.981.83
21021874-102187495.56796.72
31025156-102515695.87497.05
41066897-106689799.778100.99
51014280-101428094.85796.01
61042628-104262897.50898.65
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