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430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.462094145209899220933992091696209307620942620.14
210.782112981211388521134330.04
单位质量响应值RSD%判断
200216.25196051.301.49数据可信
供试品溶液-250602批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1176594-1765948.0148.9625.768.018.9625.78
2183316-1833168.3208.32
3234000-23400010.62010.62
4250585-25058511.37211.37
5227596-22759610.32910.33
6112456-1124565.1045.10
10min1402956-40295618.28819.2010.3118.3019.2210.31
2390604-39060417.72717.74
3460681-46068120.90720.92
4468769-46876921.27421.29
5453037-45303720.56020.58
6362658-36265816.45916.47
15min1518452-51845223.52924.215.1523.5724.265.18
2504822-50482222.91122.95
3565519-56551925.66525.72
4552670-55267025.08225.14
5555436-55543625.20825.26
6504348-50434822.88922.92
20min1576799-57679926.17726.943.2226.2627.023.24
2572100-57210025.96426.05
3608189-60818927.60227.70
4612046-61204627.77727.87
5612049-61204927.77727.87
6580084-58008426.32626.40
30min1653003-65300329.63630.142.2329.7630.272.25
2640531-64053129.07029.19
3677605-67760530.75230.89
4672490-67249030.52030.66
5676906-67690630.72030.86
6664255-66425530.14630.26
45min1698659-69865931.70832.391.5331.8832.571.53
2706334-70633432.05632.23
3708040-70804032.13332.33
4720552-72055232.70132.89
5725411-72541132.92233.11
6723354-72335432.82833.00
60min1730687-73068733.16133.541.6133.3933.771.59
2724071-72407132.86133.09
3734854-73485433.35033.60
4740630-74063033.61233.86
5746230-74623033.86634.11
6757367-75736734.37234.59
90min1733434-73343433.28635.032.8733.5735.322.84
2768375-76837534.87235.15
3773221-77322135.09135.39
4772934-77293435.07835.38
5782482-78248235.51235.81
6800776-80077636.34236.62
120min1780711-78071135.43136.092.0835.7736.442.06
2790217-79021735.86336.20
3791176-79117635.90636.27
4778397-77839735.32635.69
5813558-81355836.92237.28
6817393-81739337.09637.44
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1781174-78117435.45236.251.9035.8536.661.87
2806718-80671836.61237.01
3794014-79401436.03536.46
4792173-79217335.95236.37
5793209-79320935.99936.42
6824768-82476837.43137.83
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430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.462086437209118120894442085576208499120875260.13
210.782192885219125921920720.06
单位质量响应值RSD%判断
199572.28203346.201.33数据可信
供试品溶液-250603批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1295417-29541713.18512.945.9813.1912.946.00
2257082-25708211.47411.47
3299709-29970913.37713.38
4303109-30310913.52913.53
5285024-28502412.72212.72
6299749-29974913.37913.38
10min1460887-46088720.57120.693.2020.5920.713.19
2436584-43658419.48619.51
3471074-47107421.02621.05
4479428-47942821.39821.42
5461992-46199220.62020.64
6470760-47076021.01221.03
15min1569062-56906225.39925.291.5425.4625.351.55
2550279-55027924.56124.61
3571544-57154425.51025.57
4575543-57554325.68825.75
5566979-56697925.30625.36
6566609-56660925.29025.35
20min1629768-62976828.10927.791.5228.2127.891.52
2608813-60881327.17327.27
3627730-62773028.01828.12
4633403-63340328.27128.37
5621860-62186027.75627.85
6614751-61475127.43827.54
30min1694818-69481831.01231.151.2631.1631.291.26
2681949-68194930.43830.58
3699958-69995831.24131.39
4705230-70523031.47731.62
5699550-69955031.22331.37
6705542-70554231.49131.64
45min1750719-75071933.50733.261.3633.7033.461.36
2732138-73213832.67832.87
3747985-74798533.38533.58
4758974-75897433.87634.08
5734631-73463132.78932.99
6746339-74633933.31233.51
60min1751549-75154933.54434.331.5733.8034.581.55
2764527-76452734.12334.37
3770531-77053134.39134.65
4765640-76564034.17334.43
5774888-77488834.58634.84
6787632-78763235.15535.41
90min1802581-80258135.82236.021.3036.1336.331.30
2790919-79091935.30135.60
3804671-80467135.91536.23
4817376-81737636.48236.80
5819301-81930136.56836.88
6806656-80665636.00436.32
120min1825538-82553836.84637.000.8937.2237.370.89
2816911-81691136.46136.82
3827446-82744636.93237.30
4834031-83403137.22637.60
5837486-83748637.38037.75
6831962-83196237.13337.51
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1819379-81937936.57237.212.0337.0037.642.02
2815516-81551636.39936.82
3834301-83430137.23837.67
4860609-86060938.41238.85
5844850-84485037.70838.14
6827766-82776636.94637.38
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430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.462164263216497121606272164409216334821635240.08
210.782191563219282421921940.05
单位质量响应值RSD%判断
206837.86203357.511.20数据可信
供试品溶液-250603批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1298726-29872613.09612.0110.7913.1012.0210.80
2292682-29268212.83112.83
3216737-2167379.5029.50
4272387-27238711.94211.94
5282075-28207512.36612.37
6281675-28167512.34912.35
10min1477512-47751220.93519.859.0620.9619.879.06
2467077-46707720.47720.50
3371171-37117116.27216.29
4454196-45419619.91219.93
5466668-46666820.45920.48
6479798-47979821.03521.06
15min1571001-57100125.03324.185.9925.0924.246.00
2563774-56377424.71624.77
3485318-48531821.27721.32
4556662-55666224.40524.46
5560950-56095024.59224.65
6572175-57217525.08525.14
20min1631380-63138027.68026.526.4127.7826.616.42
2605363-60536326.54026.64
3527697-52769723.13523.21
4619765-61976527.17127.26
5621927-62192727.26627.36
6623216-62321627.32227.42
30min1700533-70053330.71229.864.8130.8630.004.82
2683901-68390129.98330.12
3615516-61551626.98527.10
4692605-69260530.36430.50
5699310-69931030.65830.80
6695104-69510430.47430.62
45min1744578-74457832.64331.606.9332.8431.796.92
2742445-74244532.54932.74
3620057-62005727.18427.35
4726645-72664531.85732.05
5746289-74628932.71832.91
6744773-74477332.65132.85
60min1774001-77400133.93333.075.2634.1833.315.26
2768866-76886633.70833.95
3673805-67380529.54029.75
4771395-77139533.81934.06
5764183-76418333.50233.75
6773840-77384033.92634.17
90min1808959-80895935.46534.107.3035.7734.407.29
2789627-78962734.61834.92
3663314-66331429.08029.34
4809445-80944535.48735.79
5804547-80454735.27235.57
6790989-79098934.67834.98
120min1823898-82389836.12035.125.2536.4935.485.26
2808980-80898035.46635.83
3718174-71817431.48531.79
4802014-80201435.16135.52
5829613-82961336.37136.73
6824502-82450236.14736.51
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1821254-82125436.00435.205.7836.4335.615.79
2812425-81242535.61736.04
3710599-71059931.15331.51
4809501-80950135.48935.91
5825587-82558736.19436.62
6838145-83814536.74537.17
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