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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.03206639
206639+0
208179
208179+0
207705
207705+0
208253
208253+0
208446
208446+0
2078440.35
218.07207079
207079+0
205561
205561+0
2063200.53
单位质量响应值RSD%判断
11527.6811417.820.68数据可信
供试品溶液-2025010321批-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12996
2996+0
-29961.4621.1218.441.461.1218.41
22337
2337+0
-23371.1401.14
32423
2423+0
-24231.1821.18
41701
1701+0
-17010.8300.83
52096
2096+0
-20961.0231.02
62274
2274+0
-22741.1091.11
10min15210
5210+0
-52102.5422.686.332.562.706.31
25597
5597+0
-55972.7312.74
36056
6056+0
-60562.9542.97
45081
5081+0
-50812.4792.49
55406
5406+0
-54062.6372.65
65639
5639+0
-56392.7512.76
15min19531
9531+0
-95314.6504.762.924.694.803.02
210151
10151+0
-101514.9525.00
310022
10022+0
-100224.8894.94
49404
9404+0
-94044.5884.62
59692
9692+0
-96924.7284.77
69744
9744+0
-97444.7544.80
20min112685
12685+0
-126856.1886.272.376.286.362.39
213057
13057+0
-130576.3706.47
313082
13082+0
-130826.3826.48
412379
12379+0
-123796.0396.13
512721
12721+0
-127216.2066.30
613164
13164+0
-131646.4226.52
30min119890
19890+0
-198909.7039.992.299.8710.162.26
221079
21079+0
-2107910.28310.45
320948
20948+0
-2094810.22010.39
420453
20453+0
-204539.97810.13
520080
20080+0
-200809.7969.96
620418
20418+0
-204189.96110.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min132179
32179+0
-3217915.69915.922.0515.9716.192.05
233363
33363+0
-3336316.27616.56
333571
33571+0
-3357116.37816.66
432356
32356+0
-3235615.78516.05
531974
31974+0
-3197415.59915.87
632318
32318+0
-3231815.76616.04
60min145459
45459+0
-4545922.17722.081.4122.6222.531.39
244561
44561+0
-4456121.73922.20
345284
45284+0
-4528422.09222.56
444778
44778+0
-4477821.84522.29
545112
45112+0
-4511222.00822.45
646378
46378+0
-4637822.62623.08
极限150787
50787+0
-5078724.77724.491.2225.4725.181.20
251009
51009+0
-5100924.88525.59
350330
50330+0
-5033024.55425.27
449755
49755+0
-4975524.27324.96
549672
49672+0
-4967224.23324.92
649600
49600+0
-4960024.19724.90
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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.03207810
207810+0
208301
208301+0
207807
207807+0
207013
207013+0
206875
206875+0
2075610.29
218.07208685
208685+0
207883
207883+0
2082840.28
单位质量响应值RSD%判断
11511.9811526.510.09数据可信
供试品溶液-2025010321批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11494
1494+0
-14940.7260.7223.050.730.7222.77
21918
1918+0
-19180.9320.93
31813
1813+0
-18130.8810.88
41045
1045+0
-10450.5080.51
51231
1231+0
-12310.5980.60
61331
1331+0
-13310.6470.65
10min12301
2301+0
-23011.1180.988.851.130.988.97
21921
1921+0
-19210.9330.94
32142
2142+0
-21421.0411.05
41958
1958+0
-19580.9510.96
51931
1931+0
-19310.9380.94
61814
1814+0
-18140.8810.89
15min13306
3306+0
-33061.6061.2215.721.631.2415.73
22433
2433+0
-24331.1821.20
32421
2421+0
-24211.1761.20
42280
2280+0
-22801.1081.12
52252
2252+0
-22521.0941.11
62392
2392+0
-23921.1621.18
20min12751
2751+0
-27511.3371.284.081.371.314.15
22681
2681+0
-26811.3031.34
32654
2654+0
-26541.2901.32
42681
2681+0
-26811.3031.33
52556
2556+0
-25561.2421.27
62453
2453+0
-24531.1921.22
30min13492
3492+0
-34921.6971.692.131.751.732.24
23507
3507+0
-35071.7041.75
33489
3489+0
-34891.6951.74
43567
3567+0
-35671.7331.78
53386
3386+0
-33861.6451.69
63378
3378+0
-33781.6411.68
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min14708
4708+0
-47082.2872.283.662.362.343.71
24722
4722+0
-47222.2942.36
35003
5003+0
-50032.4312.50
44586
4586+0
-45862.2282.29
54534
4534+0
-45342.2032.26
64580
4580+0
-45802.2252.29
60min16108
6108+0
-61082.9682.961.383.073.051.48
26170
6170+0
-61702.9983.09
36213
6213+0
-62133.0193.11
46078
6078+0
-60782.9533.04
55983
5983+0
-59832.9072.99
66042
6042+0
-60422.9363.02
极限17001
7001+0
-70013.4023.391.483.533.521.50
27026
7026+0
-70263.4143.54
37033
7033+0
-70333.4173.55
46842
6842+0
-68423.3243.44
57108
7108+0
-71083.4543.57
66870
6870+0
-68703.3383.46
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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.03207905
207905+0
208192
208192+0
208405
208405+0
207940
207940+0
207871
207871+0
2080630.12
218.07204396
204396+0
204824
204824+0
2046100.15
单位质量响应值RSD%判断
11539.8211323.191.34数据可信
供试品溶液-2025010321批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1
+0
-0.0000.00-0.000.00-
2
+0
-0.0000.00
3
+0
-0.0000.00
4
+0
-0.0000.00
5
+0
-0.0000.00
6
+0
-0.0000.00
10min11011
1011+0
-10110.4950.4310.640.500.4310.51
2960
960+0
-9600.4700.47
3809
809+0
-8090.3960.40
4828
828+0
-8280.4050.41
5886
886+0
-8860.4340.43
6769
769+0
-7690.3770.38
15min11023
1023+0
-10230.5010.4713.850.510.4713.90
2993
993+0
-9930.4860.49
31096
1096+0
-10960.5370.54
4815
815+0
-8150.3990.40
51023
1023+0
-10230.5010.51
6764
764+0
-7640.3740.38
20min1976
976+0
-9760.4780.475.320.490.485.03
21025
1025+0
-10250.5020.51
3905
905+0
-9050.4430.45
4966
966+0
-9660.4730.48
5989
989+0
-9890.4840.49
6892
892+0
-8920.4370.45
30min11017
1017+0
-10170.4980.505.440.510.515.74
21010
1010+0
-10100.4950.51
3968
968+0
-9680.4740.49
41005
1005+0
-10050.4920.51
51122
1122+0
-11220.5490.57
6974
974+0
-9740.4770.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min11205
1205+0
-12050.5900.556.030.610.576.11
21181
1181+0
-11810.5780.60
31140
1140+0
-11400.5580.58
41028
1028+0
-10280.5030.52
51144
1144+0
-11440.5600.58
61066
1066+0
-10660.5220.54
60min11468
1468+0
-14680.7190.5911.750.750.6211.46
21240
1240+0
-12400.6070.64
31106
1106+0
-11060.5420.57
41176
1176+0
-11760.5760.60
51188
1188+0
-11880.5820.61
61067
1067+0
-10670.5220.55
极限110401
10401+0
-104015.0931.34137.025.131.38133.81
21219
1219+0
-12190.5970.63
31285
1285+0
-12850.6290.66
41124
1124+0
-11240.5500.58
51234
1234+0
-12340.6040.64
61176
1176+0
-11760.5760.61
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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.03205096
205096+0
205572
205572+0
205640
205640+0
205557
205557+0
205298
205298+0
2054330.12
218.07207623
207623+0
208282
208282+0
2079520.23
单位质量响应值RSD%判断
11393.9511508.140.71数据可信
供试品溶液-2025010321批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18528
8528+0
-85284.1683.9446.934.173.9446.95
2597
597+0
-5970.2920.29
39034
9034+0
-90344.4164.42
410860
10860+0
-108605.3085.31
510604
10604+0
-106045.1835.18
68799
8799+0
-87994.3014.30
10min11097
1097+0
-10970.5360.5916.140.580.6312.38
21572
1572+0
-15720.7680.77
31092
1092+0
-10920.5340.58
41161
1161+0
-11610.5670.63
51226
1226+0
-12260.5990.66
61044
1044+0
-10440.5100.56
15min11360
1360+0
-13600.6650.706.770.720.756.55
21471
1471+0
-14710.7190.73
31415
1415+0
-14150.6920.75
41357
1357+0
-13570.6630.73
51608
1608+0
-16080.7860.85
61374
1374+0
-13740.6720.73
20min11574
1574+0
-15740.7690.844.970.830.905.25
21734
1734+0
-17340.8480.87
31718
1718+0
-17180.8400.90
41740
1740+0
-17400.8500.92
51840
1840+0
-18400.8990.97
61710
1710+0
-17100.8360.90
30min12125
2125+0
-21251.0391.062.971.111.133.50
22180
2180+0
-21801.0661.09
32202
2202+0
-22021.0761.15
42108
2108+0
-21081.0301.11
52287
2287+0
-22871.1181.20
62154
2154+0
-21541.0531.12
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min12638
2638+0
-26381.2891.352.671.371.433.15
22758
2758+0
-27581.3481.39
32751
2751+0
-27511.3451.43
42825
2825+0
-28251.3811.47
52829
2829+0
-28291.3831.48
62819
2819+0
-28191.3781.46
60min13235
3235+0
-32351.5811.653.651.681.753.36
23455
3455+0
-34551.6891.74
33225
3225+0
-32251.5761.68
43370
3370+0
-33701.6471.76
53478
3478+0
-34781.7001.81
63503
3503+0
-35031.7121.81
极限13775
3775+0
-37751.8451.903.061.962.013.47
23831
3831+0
-38311.8731.95
33855
3855+0
-38551.8842.00
43915
3915+0
-39151.9142.04
54110
4110+0
-41102.0092.14
63831
3831+0
-38311.8731.99
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