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%
116.451938381955911947761938011951101946230.41
216.521960471940791950630.72
单位质量响应值RSD%判断
11831.1911807.690.15数据可信
供试品溶液-3E99SDC1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%
5min121722-2172211.02711.965.5211.0311.965.52
223435-2343511.89711.90
324002-2400212.18412.18
423551-2355111.95511.96
522967-2296711.65911.66
625683-2568313.03813.04
10min149553-4955325.15525.541.4025.1725.561.41
250650-5065025.71225.73
351093-5109325.93725.96
449335-4933525.04425.06
550574-5057425.67325.69
650696-5069625.73525.76
15min171530-7153036.31136.460.9536.3736.520.94
271926-7192636.51236.58
371966-7196636.53336.60
471299-7129936.19436.26
573024-7302437.07037.13
671139-7113936.11336.18
20min188032-8803244.68844.780.8644.8144.900.86
289063-8906345.21245.34
388538-8853844.94545.07
487740-8774044.54044.66
588836-8883645.09745.22
687043-8704344.18644.31
30min1111940-11194056.82556.850.5357.0257.050.53
2112112-11211256.91257.11
3112871-11287157.29857.50
4112200-11220056.95757.15
5111789-11178956.74856.95
6111071-11107156.38456.58
45min1136537-13653769.31169.200.1969.6069.490.19
2136024-13602469.05169.34
3136537-13653769.31169.61
4136515-13651569.30069.59
5136248-13624869.16569.46
6136007-13600769.04269.33
60min1153890-15389078.12177.870.7678.5378.280.76
2153222-15322277.78178.19
3154233-15423378.29578.71
4151406-15140676.86077.27
5154663-15466378.51378.92
6152961-15296177.64978.06
90min1173625-17362588.13988.350.5188.6788.890.51
2173809-17380988.23288.77
3175196-17519688.93689.48
4172680-17268087.65988.19
5174571-17457188.61989.16
6174359-17435988.51189.05
120min1184419-18441993.61893.680.4394.3094.370.43
2183687-18368793.24793.93
3184249-18424993.53294.22
4184070-18407093.44194.12
5185932-18593294.38695.07
6184926-18492693.87694.56
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1194355-19435598.66298.080.7399.5098.920.72
2193418-19341898.18799.03
3193333-19333398.14398.99
4192561-19256197.75198.59
5194708-19470898.84199.69
6190829-19082996.87297.71
240min1195793-19579399.39299.860.37100.40100.860.37
2196434-19643499.718100.72
3196516-19651699.759100.77
4196712-19671299.859100.86
5197991-197991100.508101.52
6196826-19682699.917100.92
极限1198282-198282100.65699.990.43101.82101.160.42
2195766-19576699.378100.55
3196694-19669499.850101.02
4196751-19675199.878101.04
5197339-197339100.177101.35
6196978-19697899.994101.16
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%
116.453964293937903983053983193958983965480.48
216.523962063950053956060.22
单位质量响应值RSD%判断
24106.2623947.090.47数据可信
供试品溶液-3F70SDB1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%
5min154475-5447513.60412.868.9513.6012.868.94
253045-5304513.24713.25
350880-5088012.70612.71
457151-5715114.27214.27
543835-4383510.94710.95
649553-4955312.37512.37
10min1103181-10318125.76725.383.0525.7925.403.06
2103720-10372025.90125.92
3101605-10160525.37325.39
4105141-10514126.25626.28
596721-9672124.15424.17
699482-9948224.84324.86
15min1142435-14243535.57035.351.8435.6435.421.85
2144454-14445436.07436.14
3142318-14231835.54035.60
4143099-14309935.73535.80
5137231-13723134.27034.33
6139828-13982834.91934.98
20min1171710-17171042.88042.911.8843.0143.041.89
2175874-17587443.92044.05
3172411-17241143.05543.18
4173169-17316943.24543.37
5166043-16604341.46541.58
6171822-17182242.90843.03
30min1212001-21200152.94252.950.9653.1453.140.97
2213517-21351753.32153.52
3212464-21246453.05853.25
4213619-21361953.34653.55
5208096-20809651.96752.15
6212442-21244253.05253.24
45min1252160-25216062.97162.970.9363.2663.250.94
2254387-25438763.52763.81
3253393-25339363.27963.56
4253728-25372863.36263.65
5247952-24795261.92062.19
6251299-25129962.75663.04
60min1280006-28000669.92569.830.5270.3170.220.53
2280057-28005769.93770.33
3281731-28173170.35570.74
4279790-27979069.87170.26
5277334-27733469.25769.63
6278931-27893169.65670.04
90min1311695-31169577.83878.410.7478.3478.910.73
2312232-31223277.97278.48
3318200-31820079.46379.97
4313737-31373778.34878.86
5314337-31433778.49878.99
6313591-31359178.31278.81
120min1335965-33596583.89983.630.8484.5384.260.84
2331984-33198482.90583.54
3338359-33835984.49785.13
4337401-33740184.25884.90
5333820-33382083.36383.98
6331709-33170982.83683.47
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1355117-35511788.68289.370.9089.4690.140.89
2355576-35557688.79689.57
3360571-36057190.04490.82
4359667-35966789.81890.60
5361898-36189890.37591.13
6354490-35449088.52589.29
240min1370321-37032192.47892.360.9193.4093.280.90
2365669-36566991.31792.24
3370219-37021992.45393.38
4372093-37209392.92193.85
5374377-37437793.49194.40
6366308-36630891.47692.39
极限1369452-36945292.26192.121.3293.3493.201.31
2365070-36507091.16792.25
3370277-37027792.46793.55
4374253-37425393.46094.55
5372917-37291793.12794.19
6361429-36142990.25891.33
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