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%
116.091834581831111835031833981834771833890.09
216.031834261837021835640.11
单位质量响应值RSD%判断
11397.7011451.280.34数据可信
供试品溶液-24121701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%
5min137386-3738618.40822.2919.0218.4122.2919.01
240435-4043519.90919.91
342682-4268221.01521.02
459987-5998729.53629.54
551102-5110225.16125.16
640025-4002519.70719.71
10min199622-9962249.05049.5810.9649.2649.8310.99
295558-9555847.05047.27
392653-9265345.61945.85
4120873-12087359.51459.84
5104540-10454051.47251.75
690991-9099144.80145.02
15min1146166-14616671.96771.346.9872.7272.147.03
2145719-14571971.74772.49
3136557-13655767.23667.98
4160538-16053879.04380.03
5148796-14879673.26274.11
6131526-13152664.75965.48
20min1163733-16373380.61781.605.7782.1783.195.80
2171057-17105784.22385.76
3150379-15037974.04275.53
4177983-17798387.63389.50
5169940-16994083.67385.34
6161232-16123279.38580.82
30min1181773-18177389.49989.212.8591.9491.712.96
2181632-18163289.42991.91
3172429-17242984.89887.21
4188593-18859392.85795.70
5181961-18196189.59192.19
6180785-18078589.01291.33
45min1183961-18396190.57691.410.9694.0294.901.10
2187626-18762692.38195.85
3183389-18338990.29593.55
4187590-18759092.36396.24
5185922-18592291.54295.13
6185431-18543191.30094.61
60min1185908-18590891.53590.121.1095.9894.631.03
2183759-18375990.47794.97
3181560-18156089.39493.65
4182685-18268589.94894.85
5180232-18023288.74093.35
6184102-18410290.64694.97
极限1182452-18245289.83389.411.6895.3094.921.56
2178553-17855387.91393.42
3183877-18387790.53595.78
4179562-17956288.41094.31
5186103-18610391.63197.22
6179023-17902388.14593.47
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%
116.091843211843531843331841521839981842310.09
216.031843431844011843720.03
单位质量响应值RSD%判断
11450.0311501.680.32数据可信
供试品溶液-24121701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%
5min119796-197969.7039.0518.409.709.0518.39
215763-157637.7267.73
320057-200579.8319.83
415158-151587.4307.43
523915-2391511.72211.72
616121-161217.9027.90
10min155207-5520727.06026.7211.6327.1726.8211.66
249328-4932824.17924.26
357652-5765228.25928.37
451150-5115025.07225.15
565286-6528632.00132.13
648483-4848323.76523.85
15min190506-9050644.36344.955.5444.7745.355.61
287169-8716942.72743.08
392352-9235245.26745.69
490486-9048644.35344.71
5101396-10139649.70050.19
688351-8835143.30643.66
20min1123345-12334560.45960.491.9761.3661.392.06
2120200-12020058.91759.75
3125208-12520861.37262.30
4122874-12287460.22861.08
5127029-12702962.26563.30
6121823-12182359.71360.55
30min1160036-16003678.44479.611.4580.0281.181.51
2160653-16065378.74680.23
3161827-16182779.32180.93
4163549-16354980.16581.69
5166530-16653081.62783.36
6161853-16185379.33480.83
45min1184383-18438390.37892.211.2792.8294.661.29
2186591-18659191.46093.82
3188511-18851192.40194.89
4190389-19038993.32195.74
5190672-19067293.46096.10
6188195-18819592.24694.62
60min1194907-19490795.53695.500.9198.9898.980.80
2197390-19739096.753100.13
3193230-19323094.71498.23
4196152-19615296.14699.60
5192630-19263094.42098.10
6194744-19474495.45698.86
极限1196759-19675996.44495.710.65100.95100.240.64
2193384-19338494.78999.24
3195805-19580595.976100.54
4194211-19421195.19599.71
5195279-19527995.718100.44
6196077-19607796.109100.57
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%
116.091837411837021839001838031834121837120.10
216.031835131836551835840.06
单位质量响应值RSD%判断
11417.7811452.530.22数据可信
供试品溶液-24121701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%
5min15854-58542.8802.795.672.882.795.76
25804-58042.8552.86
35894-58942.8992.90
45031-50312.4752.47
55741-57412.8242.82
65717-57172.8122.81
10min113448-134486.6156.655.166.656.685.11
213969-139696.8716.90
313449-134496.6166.65
412538-125386.1686.20
513105-131056.4466.48
614558-145587.1617.19
15min125971-2597112.77512.788.7112.8812.898.66
227839-2783913.69413.80
326515-2651513.04313.15
421874-2187410.76010.86
525566-2556612.57612.68
628176-2817613.86013.97
20min140130-4013019.74020.203.6219.9920.453.63
241740-4174020.53220.79
340778-4077820.05920.31
440547-4054719.94520.16
539525-3952519.44319.69
643710-4371021.50121.77
30min167243-6724333.07733.432.9433.5433.902.96
269721-6972134.29634.78
369466-6946634.17134.64
464913-6491331.93132.37
566701-6670132.81133.27
669747-6974734.30934.81
45min196763-9676347.59848.451.4648.4349.281.47
299009-9900948.70349.57
3100468-10046849.42150.27
496852-9685247.64248.43
598922-9892248.66049.48
698897-9889748.64849.53
60min1120564-12056459.30660.131.5060.6761.511.49
2124027-12402761.01062.42
3124082-12408261.03762.44
4120436-12043659.24360.56
5123555-12355560.77762.14
6120725-12072559.38560.81
极限1138854-13885468.30366.671.8470.3368.721.75
2134768-13476866.29368.38
3132105-13210564.98367.06
4135815-13581566.80868.79
5137742-13774267.75669.80
6133904-13390465.86867.95
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