美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.222082082077322078422082652080752080240.12
219.032063342055902059620.26
单位质量响应值RSD%判断
10823.3110823.020.01数据可信
供试品溶液-2023082021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%
5min116730-167308.1008.613.758.108.613.75
217543-175438.4948.49
317750-177508.5948.59
418599-185999.0059.00
518401-184018.9098.91
617698-176988.5698.57
10min130752-3075214.88914.971.0614.9815.061.07
230640-3064014.83514.93
331247-3124715.12815.22
431275-3127515.14215.24
531071-3107115.04315.14
630502-3050214.76814.86
15min136562-3656217.70218.071.5017.9618.331.50
237038-3703817.93218.19
338008-3800818.40218.67
437034-3703417.93018.20
537340-3734018.07818.34
637914-3791418.35618.62
20min140548-4054819.63219.751.7920.0820.221.75
240667-4066719.68920.15
340090-4009019.41019.88
442191-4219120.42720.89
540872-4087219.78920.26
640428-4042819.57420.04
30min144272-4427221.43521.570.9322.1022.250.91
245099-4509921.83522.51
344091-4409121.34722.03
444358-4435821.47622.17
545023-4502321.79822.49
644466-4446621.52922.21
45min146671-4667122.59622.791.1723.5023.711.16
247235-4723522.86923.79
346397-4639722.46323.38
447891-4789123.18724.12
547429-4742922.96323.89
646842-4684222.67923.60
60min147174-4717422.84023.030.7224.0024.210.70
248045-4804523.26124.44
347434-4743422.96624.14
447438-4743822.96724.16
547422-4742222.96024.14
647948-4794823.21424.39
极限146141-4614122.34023.021.6423.7524.451.58
247734-4773423.11124.54
348197-4819723.33524.76
447285-4728522.89324.34
548263-4826323.36724.81
647618-4761823.05524.48
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.222071992067822059932061942058222063980.28
219.032070982069192070080.07
单位质量响应值RSD%判断
10738.7110877.980.92数据可信
供试品溶液-t2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%
5min117592-175928.5298.712.278.538.712.28
218215-182158.8318.83
317371-173718.4228.42
418416-184168.9298.93
518232-182328.8408.84
617949-179498.7028.70
10min131190-3119015.12215.180.6215.2215.280.60
231476-3147615.26115.36
331584-3158415.31315.41
431159-3115915.10715.21
531324-3132415.18715.29
631100-3110015.07915.18
15min138046-3804618.44618.272.4018.7118.532.36
239277-3927719.04319.31
337673-3767318.26518.53
436966-3696617.92318.19
537251-3725118.06118.33
636840-3684017.86218.13
20min141702-4170220.21919.901.5720.6920.371.55
241681-4168120.20920.69
341212-4121219.98120.45
440040-4004019.41319.88
540610-4061019.68920.16
640999-4099919.87820.34
30min145336-4533621.98121.871.0922.6722.561.06
245452-4545222.03722.74
345303-4530321.96522.65
445583-4558322.10122.78
544476-4447621.56422.25
644513-4451321.58222.27
45min147118-4711822.84523.000.6223.7823.940.63
247988-4798823.26724.22
347444-4744423.00323.94
447388-4738822.97623.90
547333-4733322.94923.88
647370-4737022.96723.89
60min148254-4825423.39623.351.4424.5924.541.41
248824-4882423.67224.88
348657-4865723.59124.78
448291-4829123.41324.60
548098-4809823.32024.50
646862-4686222.72123.90
极限148837-4883723.67823.630.8925.1325.080.89
249540-4954024.01925.49
348753-4875323.63725.09
448377-4837723.45524.90
548396-4839623.46424.90
648566-4856623.54724.98
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.222049192052452043832040242035122044170.34
219.031954301952871953580.06
单位质量响应值RSD%判断
10635.6410265.792.51数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2023082121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%
5min118701-187019.3809.813.459.389.813.47
219853-198539.9589.96
320492-2049210.27810.28
419589-195899.8259.83
519871-198719.9679.97
618866-188669.4639.46
10min130842-3084215.46915.932.5115.5716.042.53
231667-3166715.88315.99
332962-3296216.53316.65
431935-3193516.01816.13
532191-3219116.14616.26
630949-3094915.52315.63
15min136778-3677818.44718.871.5118.7219.161.54
237598-3759818.85819.15
338276-3827619.19819.50
437350-3735018.73419.02
538236-3823619.17819.47
637477-3747718.79719.07
20min141896-4189621.01420.681.1821.4921.171.11
241753-4175320.94221.44
340785-4078520.45720.97
440787-4078720.45820.95
541042-4104220.58521.09
641096-4109620.61321.10
30min145336-4533622.73922.671.4523.4523.401.43
245172-4517222.65723.39
346099-4609923.12223.86
445585-4558522.86423.59
544820-4482022.48023.21
644194-4419422.16622.88
45min146245-4624523.19523.471.2524.1624.451.21
247505-4750523.82724.81
346437-4643723.29124.29
446475-4647523.31024.29
547573-4757323.86124.84
646564-4656423.35524.32
60min147568-4756823.85924.081.2825.0825.321.25
248228-4822824.19025.44
347547-4754723.84825.10
448288-4828824.22025.46
549019-4901924.58625.83
647430-4743023.78925.01
极限151030-5103025.59524.692.4827.0926.202.33
249079-4907924.61726.13
349068-4906824.61126.13
450207-5020725.18226.69
547786-4778623.96825.49
648172-4817224.16225.65
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