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%
116.554039854040634036934036964038594038590.05
216.454061414054984058200.12
单位质量响应值RSD%判断
24402.3624669.910.78数据可信
供试品溶液-25031701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%
5min145814-4581411.20410.872.8111.2010.872.80
242269-4226910.33710.34
344244-4424410.82010.82
444399-4439910.85810.86
544537-4453710.89110.89
645497-4549711.12611.13
10min177015-7701518.83418.223.6118.8518.243.60
275421-7542118.44418.46
369524-6952417.00217.02
473959-7395918.08618.10
576447-7644718.69518.71
674692-7469218.26618.28
15min1101917-10191724.92324.103.0424.9724.143.04
2100989-10098924.69624.74
394163-9416323.02723.07
497441-9744123.82923.88
5100215-10021524.50724.56
696491-9649123.59623.65
20min1121544-12154429.72328.992.9529.8129.082.94
2122004-12200429.83529.92
3112580-11258027.53127.62
4116841-11684128.57328.66
5119730-11973029.27929.37
6118625-11862529.00929.10
30min1153253-15325337.47736.223.5537.6236.363.55
2153768-15376837.60337.74
3140064-14006434.25234.38
4145192-14519235.50635.64
5149970-14997036.67436.81
6146404-14640435.80235.94
45min1187197-18719745.77844.373.3945.9844.573.39
2188571-18857146.11446.32
3171593-17159341.96242.15
4178756-17875643.71443.91
5180809-18080944.21644.42
6181644-18164444.42044.62
60min1211861-21186151.80950.283.2952.0950.553.28
2213914-21391452.31252.59
3195542-19554247.81948.08
4201388-20138849.24849.52
5204909-20490950.10950.38
6206045-20604550.38750.66
90min1248301-24830160.72158.873.5061.0959.233.50
2251792-25179261.57461.94
3228612-22861255.90656.24
4235869-23586957.68058.03
5238971-23897158.43958.80
6240920-24092058.91659.27
120min1272067-27206766.53364.343.5667.0064.793.56
2274060-27406067.02067.49
3249038-24903860.90161.33
4257842-25784263.05463.50
5260432-26043263.68764.14
6265153-26515364.84265.29
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1323260-32326079.05176.263.5179.6376.823.51
2326635-32663579.87780.46
3297749-29774972.81373.34
4307467-30746775.18975.74
5307259-30725975.13975.70
6308730-30873075.49876.06
240min1-0.0000.00-0.710.693.24
2-0.0000.71
3-0.0000.65
4-0.0000.68
5-0.0000.69
6-0.0000.69
极限1-0.0000.00-0.710.693.24
2-0.0000.71
3-0.0000.65
4-0.0000.68
5-0.0000.69
6-0.0000.69
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%
116.554057984060814062884060014059454060230.05
216.454081274081094081180.01
单位质量响应值RSD%判断
24533.1124809.600.80数据可信
供试品溶液-25031701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%
5min137631-376319.1529.445.459.159.445.45
235859-358598.7218.72
340184-401849.7739.77
438143-381439.2779.28
539090-390909.5079.51
641944-4194410.20110.20
10min165545-6554515.94115.911.3815.9615.931.37
266140-6614016.08616.10
366151-6615116.08816.10
465575-6557515.94815.96
565432-6543215.91315.93
663707-6370715.49415.51
15min187054-8705421.17221.112.3121.2121.152.29
289025-8902521.65121.69
387117-8711721.18721.23
487619-8761921.30921.35
587006-8700621.16021.20
683033-8303320.19420.24
20min1104670-10467025.45625.402.6125.5325.482.60
2106662-10666225.94126.02
3104778-10477825.48225.56
4106549-10654925.91325.99
5104712-10471225.46625.54
699221-9922124.13124.21
30min1130372-13037231.70731.772.9431.8331.892.93
2132690-13269032.27132.39
3130863-13086331.82631.95
4134922-13492232.81432.93
5131391-13139131.95532.07
6123550-12355030.04830.16
45min1160114-16011438.94039.023.6639.1139.203.65
2161640-16164039.31239.49
3161675-16167539.32039.49
4168027-16802740.86541.04
5161329-16132939.23639.41
6149932-14993236.46436.63
60min1181959-18195944.25344.503.7444.4944.743.74
2184746-18474644.93145.17
3183792-18379244.69944.94
4192481-19248146.81247.06
5183767-18376744.69344.93
6171222-17122241.64241.87
90min1215928-21592852.51552.704.2152.8353.014.20
2217970-21797053.01153.33
3217823-21782352.97653.29
4229042-22904255.70456.03
5218566-21856653.15653.47
6200725-20072548.81749.11
120min1236717-23671757.57157.974.2357.9758.364.21
2240578-24057858.51058.91
3240753-24075358.55258.95
4251585-25158561.18761.60
5239849-23984958.33258.73
6220594-22059453.64954.03
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1263997-26399764.20564.544.2264.7065.044.21
2267028-26702864.94265.44
3267679-26767965.10165.60
4279967-27996768.08968.61
5268033-26803365.18765.69
6245491-24549159.70560.17
240min1279157-27915767.89268.484.1568.4969.094.15
2282834-28283468.78769.40
3284911-28491169.29269.90
4297074-29707472.25072.88
5284357-28435769.15769.76
6261198-26119863.52564.09
极限1285392-28539269.40969.844.1270.1270.564.12
2288636-28863670.19870.92
3290416-29041670.63171.35
4303111-30311173.71874.47
5288892-28889270.26070.98
6266513-26651364.81765.49
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