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%
118.84203117
203117+0		202852
202852+0		202642
202642+0		203054
203054+0		203214
203214+0		2029760.12
218.83201867
201867+0		202387
202387+0		2021270.19
单位质量响应值RSD%判断
10773.6710734.310.26数据可信
供试品溶液-1251473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%
5min132303
32303+0		-3230315.74014.8310.6215.7414.8310.63
225984
25984+0		-2598412.66112.66
331005
31005+0		-3100515.10815.11
428351
28351+0		-2835113.81513.81
529658
29658+0		-2965814.45214.45
635294
35294+0		-3529417.19817.20
10min157711
57711+0		-5771128.12127.826.7228.3027.986.73
251935
51935+0		-5193525.30725.45
357433
57433+0		-5743327.98628.15
456457
56457+0		-5645727.51027.66
555346
55346+0		-5534626.96927.13
663644
63644+0		-6364431.01231.20
15min167752
67752+0		-6775233.01433.355.8033.5033.825.82
265347
65347+0		-6534731.84232.26
367925
67925+0		-6792533.09833.58
467729
67729+0		-6772933.00333.46
565719
65719+0		-6571932.02332.48
676216
76216+0		-7621637.13837.67
20min175931
75931+0		-7593136.99937.235.2737.8538.075.29
273335
73335+0		-7333535.73436.51
375259
75259+0		-7525936.67237.52
475371
75371+0		-7537136.72637.55
574120
74120+0		-7412036.11736.93
684374
84374+0		-8437441.11342.06
30min183718
83718+0		-8371840.79442.305.7242.0643.565.72
284068
84068+0		-8406840.96442.14
385807
85807+0		-8580741.81143.07
486356
86356+0		-8635642.07943.31
584236
84236+0		-8423641.04642.26
696711
96711+0		-9671147.12548.53
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min193740
93740+0		-9374045.67746.878.3547.4048.608.27
291070
91070+0		-9107044.37646.00
393586
93586+0		-9358645.60247.32
494850
94850+0		-9485046.21847.92
591561
91561+0		-9156144.61546.29
6112313
107877+5545*0.8		-11231354.72756.66
60min1104569
99465+6380*0.8		-10456950.95450.605.9353.1852.855.93
2101089.2
96142+6184*0.8		-101089.249.25851.38
3102463
97499+6205*0.8		-10246349.92852.15
4104378.8
99306+6341*0.8		-104378.850.86153.08
595937
91017+6150*0.8		-9593746.74848.92
6114645.2
108878+7209*0.8		-114645.255.86458.40
极限1109487.4
104013+6843*0.8		-109487.453.35054.546.1656.1457.356.17
2107703.4
102253+6813*0.8		-107703.452.48155.15
3109919.6
104366+6942*0.8		-109919.653.56156.34
4111869
106137+7165*0.8		-11186954.51157.29
5107041.2
101606+6794*0.8		-107041.252.15854.85
6125562.6
118973+8237*0.8		-125562.661.18364.34
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%
118.84203365
203365+0		202749
202749+0		203197
203197+0		203869
203869+0		202529
202529+0		2031420.26
218.83199124
199124+0		198557
198557+0		1988400.21
单位质量响应值RSD%判断
10782.4810559.751.48数据可信
供试品溶液-1251473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%
5min132374
32374+0		-3237415.89915.1710.9815.9015.1610.98
234663
34663+0		-3466317.02317.02
331170
31170+0		-3117015.30815.31
428319
28319+0		-2831913.90813.91
533240
33240+0		-3324016.32416.32
625520
25520+0		-2552012.53312.53
10min158165
58165+0		-5816528.56528.171.9628.7428.342.00
257419
57419+0		-5741928.19928.39
358609
58609+0		-5860928.78328.95
456451
56451+0		-5645127.72427.88
557892
57892+0		-5789228.43128.61
655636
55636+0		-5563627.32327.46
15min171658
71658+0		-7165835.19234.382.4035.6934.862.43
270507
70507+0		-7050734.62735.13
370444
70444+0		-7044434.59635.09
468990
68990+0		-6899033.88234.34
571258
71258+0		-7125834.99635.49
667120
67120+0		-6712032.96333.41
20min178370
78370+0		-7837038.48837.911.2839.3738.771.32
278002
78002+0		-7800238.30839.19
376899
76899+0		-7689937.76638.64
476274
76274+0		-7627437.45938.30
577666
77666+0		-7766638.14339.03
675924
75924+0		-7592437.28738.10
30min186506
86506+0		-8650642.48442.881.4543.8044.171.45
288183
88183+0		-8818343.30844.62
389136
89136+0		-8913643.77645.07
487398
87398+0		-8739842.92244.18
587171
87171+0		-8717142.81144.12
685533
85533+0		-8553342.00643.23
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min197876
97876+0		-9787648.06849.786.7149.8551.546.51
299887.2
95824+5079*0.8		-99887.249.05650.85
3100438.8
96410+5036*0.8		-100438.849.32651.11
4101402.4
97272+5163*0.8		-101402.449.80051.53
5114268.6
109619+5812*0.8		-114268.656.11857.90
694353
94353+0		-9435346.33848.03
60min1104490.2
99467+6279*0.8		-104490.251.31651.901.1353.6454.221.08
2106906.8
101606+6626*0.8		-106906.852.50354.84
3107359
102131+6535*0.8		-10735952.72555.05
4105301.6
100076+6532*0.8		-105301.651.71554.00
5104625.8
99213+6766*0.8		-104625.851.38353.79
6105405.2
100402+6254*0.8		-105405.251.76653.97
极限1112108.6
106103+7507*0.8		-112108.655.05855.590.7757.9558.480.81
2113954.8
107914+7551*0.8		-113954.855.96458.89
3113310.8
107430+7351*0.8		-113310.855.64858.56
4112474.4
106512+7453*0.8		-112474.455.23758.10
5114381
108433+7435*0.8		-11438156.17459.15
6112944.2
107069+7344*0.8		-112944.255.46858.25
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