托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品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1000
标示量(mg)15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%
116.453960624012624005753970224004553990750.60
216.524006893968653987770.68
单位质量响应值RSD%判断
24259.8824139.040.36数据可信
供试品溶液-3A75SDB1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%
5min177755-7775519.27913.2722.6319.2813.2722.64
250433-5043312.50412.50
352347-5234712.97912.98
447720-4772011.83211.83
547508-4750811.77911.78
645423-4542311.26211.26
10min1101369-10136925.13424.921.9925.1724.951.99
2104090-10409025.80825.83
3100439-10043924.90324.92
499384-9938424.64124.66
599092-9909224.56924.59
698787-9878724.49324.51
15min1140630-14063034.86834.652.5134.9434.712.50
2142327-14232735.28935.35
3144069-14406935.72135.78
4135266-13526633.53833.60
5140296-14029634.78534.85
6135910-13591033.69833.76
20min1169684-16968442.07240.992.7642.2041.112.76
2170423-17042342.25542.38
3158836-15883639.38239.50
4165154-16515440.94841.07
5166430-16643041.26541.38
6161400-16140040.01840.13
30min1210201-21020152.11750.693.1852.3250.883.17
2209606-20960651.97052.16
3192547-19254747.74047.93
4206170-20617051.11851.30
5205732-20573251.00951.20
6202331-20233150.16650.35
45min1248844-24884461.69960.383.1361.9960.663.13
2250613-25061362.13762.42
3229329-22932956.86057.13
4246050-24605061.00661.28
5244398-24439860.59660.87
6241957-24195759.99160.26
60min1278724-27872469.10767.343.6669.5067.723.65
2276148-27614868.46868.85
3251817-25181762.43662.80
4275747-27574768.36968.74
5275020-27502068.18968.56
6272181-27218167.48567.85
90min1311419-31141977.21475.833.3377.7276.323.32
2310015-31001576.86577.36
3285280-28528070.73371.20
4310428-31042876.96877.45
5310596-31059677.00977.50
6307285-30728576.18976.67
120min1331095-33109582.09280.892.7282.7381.502.72
2332681-33268182.48583.11
3308707-30870776.54177.13
4328346-32834681.41082.02
5330150-33015081.85882.47
6326503-32650380.95381.56
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1354769-35476987.96286.223.7688.7386.973.75
2355492-35549288.14188.90
3321890-32189079.81080.52
4352963-35296387.51488.26
5354620-35462087.92588.68
6346775-34677585.98086.72
托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品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1000
标示量(mg)15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%
116.454065964036444067214061604036034053450.40
216.524008404035464021930.48
单位质量响应值RSD%判断
24641.0324345.820.86数据可信
供试品溶液-3A75SDB1批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min125995-259956.3686.143.486.376.143.48
225240-252406.1836.18
324207-242075.9305.93
424208-242085.9305.93
526143-261436.4046.40
624553-245536.0156.01
10min172190-7219017.68517.911.1917.7017.921.17
273324-7332417.96217.97
372296-7229617.71117.72
472603-7260317.78617.80
574305-7430518.20318.21
673820-7382018.08418.09
15min1103074-10307425.25025.391.4225.2925.441.42
2103663-10366325.39525.43
3102003-10200324.98825.03
4103059-10305925.24725.29
5106362-10636226.05626.10
6103815-10381525.43225.47
20min1131422-13142232.19531.501.4632.2831.581.46
2127310-12731031.18731.27
3127646-12764631.27031.35
4127474-12747431.22831.31
5130504-13050431.97032.05
6127142-12714231.14631.23
30min1164050-16405040.18840.321.6940.3240.461.69
2164421-16442140.27940.41
3161019-16101939.44539.58
4166008-16600840.66740.80
5169164-16916441.44141.58
6162982-16298239.92640.06
45min1208183-20818350.99951.011.5151.2051.211.51
2210144-21014451.48051.68
3202186-20218649.53049.73
4208144-20814450.99051.19
5210597-21059751.59051.80
6210108-21010851.47151.67
60min1240919-24091959.01958.531.5459.3158.821.54
2235419-23541957.67157.96
3233269-23326957.14557.43
4240153-24015358.83159.12
5241706-24170659.21159.50
6242098-24209859.30759.59
90min1277621-27762168.01068.521.1068.4068.911.10
2277499-27749967.98068.36
3276446-27644667.72268.10
4279990-27999068.59068.97
5282835-28283569.28769.68
6283869-28386969.54069.93
120min1303139-30313974.26174.512.0074.7675.012.00
2303368-30336874.31774.81
3293915-29391572.00172.49
4303858-30385874.43774.94
5311090-31109076.20976.72
6309634-30963475.85276.35
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1313983-31398376.91777.611.3977.5478.231.39
2315000-31500077.16677.79
3311173-31117376.22976.84
4316877-31687777.62678.25
5322773-32277379.07179.70
6321055-32105578.65079.28
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