厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数2500
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.498148338138448148418135028143078142650.08
214.608144128160478152300.15
单位质量响应值RSD%判断
56194.9655837.670.46数据可信
供试品溶液-2批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1909789-9097897.7785.9137.797.785.9137.78
2957384-9573848.1858.18
3671864-6718645.7445.74
4720165-7201656.1576.16
5220921-2209211.8891.89
6669538-6695385.7245.72
10min11940234-194023416.58815.5114.7016.6715.5814.79
21953588-195358816.70216.79
31906802-190680216.30216.37
41904047-190404716.27816.35
51271579-127157910.87110.89
61909331-190933116.32316.39
15min12191247-219124718.73418.422.9919.0018.663.16
22203437-220343718.83819.11
32173859-217385918.58518.83
42108654-210865418.02718.28
52046274-204627417.49417.64
62207134-220713418.86919.11
20min12208453-220845318.88118.840.4019.3619.280.43
22205854-220585418.85819.34
32191127-219112718.73319.18
42194812-219481218.76419.21
52210728-221072818.90019.24
62211499-221149918.90719.36
30min12209750-220975018.89219.021.4619.5819.681.18
22208367-220836718.88019.58
32202453-220245318.82919.49
42247733-224773319.21719.87
52281150-228115019.50220.05
62201529-220152918.82119.49
45min12228519-222851919.05218.930.7719.9519.800.63
22198340-219834018.79419.70
32195103-219510318.76719.64
42223143-222314319.00619.88
52236087-223608719.11719.88
62206007-220600718.86019.73
60min12171122-217112218.56218.711.4419.6719.791.16
22192389-219238918.74319.86
32159277-215927718.46019.54
42175951-217595118.60319.69
52248302-224830219.22120.20
62186658-218665818.69419.78
极限12153644-215364418.41218.440.9019.7319.720.64
22151136-215113618.39119.71
32154065-215406518.41619.70
42137472-213747218.27419.56
52194315-219431518.76019.95
62152817-215281718.40519.70
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数2500
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.498055928056848051318052478043248051960.07
214.608101868116298109080.13
单位质量响应值RSD%判断
55569.0855541.640.04数据可信
供试品溶液-2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%
5min131694-316940.2730.2148.830.270.2148.99
217159-171590.1480.15
345142-451420.3890.39
415213-152130.1310.13
518746-187460.1620.16
617395-173950.1500.15
10min169044-690440.5950.5326.610.600.5326.51
246106-461060.3970.40
389131-891310.7680.77
446167-461670.3980.40
557948-579480.5000.50
657599-575990.4970.50
15min196114-961140.8290.7811.430.840.7911.41
278339-783390.6750.68
3106963-1069630.9220.93
481209-812090.7000.71
590923-909230.7840.79
691147-911470.7860.79
20min1110942-1109420.9560.916.440.980.936.97
297964-979640.8440.86
3116266-1162661.0021.03
499856-998560.8610.87
5105168-1051680.9070.92
6105765-1057650.9120.93
30min1123504-1235041.0651.062.611.091.083.13
2118445-1184451.0211.04
3127989-1279891.1031.14
4120676-1206761.0401.06
5122538-1225381.0561.08
6123434-1234341.0641.09
45min1135657-1356571.1691.171.211.211.211.48
2134502-1345021.1591.19
3138778-1387781.1961.24
4135279-1352791.1661.20
5134421-1344211.1591.20
6136661-1366611.1781.22
60min1142824-1428241.2311.230.521.291.280.99
2141805-1418051.2221.27
3143658-1436581.2381.30
4142266-1422661.2261.27
5141686-1416861.2211.27
6142600-1426001.2291.28
极限1146265-1462651.2611.260.761.331.330.78
2147576-1475761.2721.33
3147406-1474061.2711.34
4144554-1445541.2461.31
5146247-1462471.2611.32
6147024-1470241.2671.33
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数2500
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.498254258247268252238245538210468241950.22
214.608199708204188201940.04
单位质量响应值RSD%判断
56880.2656177.670.88数据可信
供试品溶液-2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%
5min1118207-1182071.0012.3544.721.002.3544.70
2459721-4597213.8953.89
3157051-1570511.3311.33
4319755-3197552.7092.71
5288101-2881012.4412.44
6322516-3225162.7322.73
10min1784292-7842926.6457.5511.206.667.5811.31
21073321-10733219.0939.14
3832432-8324327.0527.07
4919403-9194037.7897.82
5866109-8661097.3387.36
6872537-8725377.3927.42
15min11216506-121650610.30610.595.9110.3910.705.99
21392486-139248611.79711.94
31227952-122795210.40310.50
41263305-126330510.70310.82
51198879-119887910.15710.27
61199821-119982110.16510.28
20min11406766-140676611.91812.214.1912.1212.444.29
21557390-155739013.19413.47
31444583-144458312.23812.45
41442376-144237612.22012.46
51398401-139840111.84712.07
61400246-140024611.86312.09
30min11650885-165088513.98614.182.8614.3214.552.97
21766637-176663714.96715.39
31684667-168466714.27214.62
41648727-164872713.96814.34
51643803-164380313.92614.28
61649501-164950113.97514.33
45min11880213-188021315.92915.611.7116.4216.131.75
21876452-187645215.89716.49
31849106-184910615.66616.17
41832682-183268215.52616.05
51809844-180984415.33315.84
61808073-180807315.31815.83
60min11937439-193743916.41416.440.9717.0817.131.08
21967871-196787116.67217.44
31955881-195588116.57017.25
41924864-192486416.30717.01
51935809-193580916.40017.08
61918352-191835216.25216.93
极限12011305-201130517.04017.171.0617.8918.040.96
22004946-200494616.98617.94
32005487-200548716.99017.85
42048371-204837117.35418.23
52037198-203719817.25918.12
62049574-204957417.36418.23
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