坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检所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4000
标示量(mg)8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%
116.091886981888181883391883141883701885080.13
216.031887251888661887960.06
单位质量响应值RSD%判断
11715.8511777.670.38数据可信
供试品溶液-24121702批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165339-6533931.28831.827.3631.2931.827.36
275038-7503835.93335.93
368179-6817932.64832.65
463644-6364430.47630.48
565840-6584031.52831.53
660694-6069429.06429.06
10min1136139-13613965.19163.873.5665.5464.233.57
2138901-13890166.51466.91
3136623-13662365.42365.79
4129671-12967162.09462.43
5132632-13263263.51263.86
6126361-12636160.50960.83
15min1169929-16992981.37280.962.7982.4482.022.78
2168060-16806080.47781.62
3174774-17477483.69284.78
4162757-16275777.93878.97
5173711-17371183.18384.24
6165139-16513979.07880.07
20min1185542-18554288.84887.562.0290.8289.521.97
2179422-17942285.91887.95
3185759-18575988.95290.97
4178560-17856085.50587.40
5180712-18071286.53688.52
6187058-18705889.57491.45
30min1190924-19092491.42691.931.7194.3994.871.68
2192457-19245792.16095.15
3194190-19419092.99096.00
4186237-18623789.18192.03
5192331-19233192.09995.04
6195725-19572593.72596.59
45min1191124-19112491.52192.021.1095.5095.981.05
2191742-19174291.81795.83
3191109-19110991.51495.56
4190098-19009891.03094.87
5192802-19280292.32596.29
6196068-19606893.88997.80
60min1185953-18595389.04589.692.2894.0494.672.14
2180835-18083586.59491.63
3188902-18890290.45795.52
4186997-18699789.54594.39
5187156-18715689.62194.61
6193978-19397892.88897.84
极限1176433-17643384.48788.272.3390.4794.242.16
2183760-18376087.99593.99
3186871-18687189.48595.55
4188997-18899790.50396.34
5185451-18545188.80594.79
6184458-18445888.32994.32
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检所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4000
标示量(mg)8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%
116.091894731888151887781888571888961889640.16
216.031890311894631892470.17
单位质量响应值RSD%判断
11744.1911805.800.37数据可信
供试品溶液-t2批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126020-2602012.43011.387.3212.4311.387.31
222887-2288710.93310.93
325127-2512712.00312.00
424571-2457111.73811.74
523147-2314711.05811.06
621218-2121810.13610.14
10min173198-7319834.96733.175.1935.1133.295.20
269774-6977433.33233.45
373298-7329835.01535.15
469541-6954133.22033.35
566520-6652031.77731.90
664235-6423530.68630.80
15min1114860-11486054.87054.382.5555.4054.882.58
2115962-11596255.39655.89
3117468-11746856.11656.64
4113423-11342354.18354.68
5111816-11181653.41653.89
6109467-10946752.29452.75
20min1149016-14901671.18769.632.2472.3270.732.24
2149338-14933871.34072.45
3146698-14669870.07971.23
4144177-14417768.87569.98
5140785-14078567.25468.32
6144586-14458669.07070.10
30min1177161-17716184.63283.514.1386.5685.384.01
2180116-18011686.04387.94
3160516-16051676.68078.60
4175153-17515383.67285.54
5176887-17688784.50186.32
6178987-17898785.50487.31
45min1194465-19446592.89893.762.0595.7796.562.01
2201030-20103096.03498.89
3191982-19198291.71294.49
4200577-20057795.81898.61
5192218-19221891.82594.58
6197310-19731094.25797.01
60min1197666-19766694.42795.881.1798.3399.721.12
2203873-20387397.392101.32
3198998-19899895.06398.86
4199575-19957595.33999.20
5202254-20225496.619100.39
6201848-20184896.425100.22
极限1200852-20085295.94996.531.26100.90101.441.20
2204098-20409897.500102.50
3205351-20535198.098102.95
4198332-19833294.74599.67
5200918-20091895.981100.83
6202899-20289996.927101.80
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检所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4000
标示量(mg)8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%
116.091887881892211891561887591888471889540.12
216.031904571900511902540.16
单位质量响应值RSD%判断
11743.5711868.620.75数据可信
供试品溶液-24121702批-pH4.5(内含1.0%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17596-75963.6193.603.783.623.603.78
27522-75223.5843.58
37581-75813.6123.61
47286-72863.4723.47
57290-72903.4733.47
68066-80663.8433.84
10min119514-195149.2988.844.859.348.884.86
218907-189079.0089.05
317402-174028.2918.33
418243-182438.6928.73
517742-177428.4538.49
619510-195109.2969.34
15min136658-3665817.46617.013.1917.6117.153.20
235828-3582817.07117.21
333733-3373316.07216.20
435571-3557116.94817.08
535514-3551416.92117.05
636961-3696117.61117.76
20min152098-5209824.82324.672.1825.1625.002.20
252358-5235824.94725.28
349708-4970823.68423.99
451860-5186024.70925.03
551583-5158324.57724.90
653036-5303625.27025.61
30min181514-8151438.83838.051.8339.4538.651.83
280493-8049338.35238.96
378520-7852037.41237.99
479404-7940437.83338.43
577990-7799037.15937.75
681248-8124838.71239.33
45min1110928-11092852.85352.761.0253.9053.781.04
2111494-11149453.12354.16
3110231-11023152.52153.51
4109767-10976752.30053.32
5109507-10950752.17653.18
6112466-11246653.58654.64
60min1135386-13538664.50664.100.9766.1465.720.98
2136288-13628864.93666.56
3133383-13338363.55265.13
4133163-13316363.44765.05
5133678-13367863.69365.28
6135347-13534764.48866.14
极限1149466-14946671.21568.793.1473.5671.123.02
2146658-14665869.87772.22
3144029-14402968.62470.90
4144616-14461668.90471.21
5145499-14549969.32571.62
6136034-13603464.81567.18
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