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%
1 18.15202677
202677+0
203305
203305+0
202043
202043+0
202511
202511+0
202665
202665+0
2026400.23
218.07203303
203303+0
202938
202938+0
2031200.13
单位质量响应值RSD%判断
11164.7411240.730.48数据可信
供试品溶液-2025010621批-磷酸盐溶液(pH7.8)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min198831
95628+3203*1
-9883149.37645.0313.4449.3845.0313.44
287200
84397+2803*1
-8720043.56643.57
396321
93320+3001*1
-9632148.12248.12
494763
91766+2997*1
-9476347.34447.34
566804
64671+2133*1
-6680433.37633.38
696837
93850+2987*1
-9683748.38048.38
10min1150513
144361+6152*1
-15051375.19773.992.5275.7574.492.59
2150092
144106+5986*1
-15009274.98775.47
3149677
143663+6014*1
-14967774.77975.31
4147115
141322+5793*1
-14711573.49974.03
5140936
135665+5271*1
-14093670.41270.78
6150290
144403+5887*1
-15029075.08675.62
15min1172554
162134+10420*1
-17255486.20984.052.8287.5985.382.85
2171456
161353+10103*1
-17145685.66086.98
3172812
162595+10217*1
-17281286.33887.70
4165539
155891+9648*1
-16553982.70484.05
5161225
152414+8811*1
-16122580.54981.70
6165863
156307+9556*1
-16586382.86684.24
20min1183165
169704+13461*1
-18316591.51090.132.1493.8592.382.18
2184606
171268+13338*1
-18460692.23094.50
3181925
168743+13182*1
-18192590.89193.22
4177047
164382+12665*1
-17704788.45490.72
5174520
162812+11708*1
-17452087.19189.24
6181094
168352+12742*1
-18109490.47592.77
30min1189365
167152+22213*1
-18936594.60894.481.3297.9797.741.34
2192976
170420+22556*1
-19297696.41299.71
3191007
168806+22201*1
-19100795.42898.76
4187351
165895+21456*1
-18735193.60196.85
5187033
166717+20316*1
-18703393.44396.46
6186911
165934+20977*1
-18691193.38296.68
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1194893
163156+31737*1
-19489397.36997.610.84101.78101.920.82
2198386
166184+32202*1
-19838699.115103.48
3195176
163564+31612*1
-19517697.511101.91
4193718
162860+30858*1
-19371896.782101.07
5195739
166077+29662*1
-19573997.792101.85
6194367
164026+30341*1
-19436797.107101.44
60min1192732
149558+43174*1
-19273296.29095.790.77101.78101.180.65
2190847
148223+42624*1
-19084795.348100.81
3189512
147222+42290*1
-18951294.681100.16
4192532
150217+42315*1
-19253296.190101.55
5193527
152783+40744*1
-19352796.687101.83
6191191
150009+41182*1
-19119195.520100.93
极限1196253
147104+49149*1
-19625398.04997.151.09104.61103.611.05
2197499
147769+49730*1
-19749998.671105.20
3192897
144503+48394*1
-19289796.372102.90
4192175
145025+47150*1
-19217596.012102.44
5194908
148698+46210*1
-19490897.377103.59
6193035
146487+46548*1
-19303596.441102.92
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%
1 18.15201989
201989+0
202982
202982+0
202312
202312+0
203070
203070+0
202696
202696+0
2026100.23
218.07201046
201046+0
200891
200891+0
2009680.06
单位质量响应值RSD%判断
11163.0911121.640.27数据可信
供试品溶液-2025010621批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121761
20839+922*1
-2176110.93110.467.5010.9310.467.49
218432
17545+887*1
-184329.2599.26
322792
21912+880*1
-2279211.44911.45
420811
19918+893*1
-2081110.45410.45
519704
18801+903*1
-197049.8979.90
621498
20494+1004*1
-2149810.79910.80
10min135028
33854+1174*1
-3502817.59517.212.8517.7217.322.86
232771
31569+1202*1
-3277116.46116.56
334426
33352+1074*1
-3442617.29217.42
435399
34110+1289*1
-3539917.78117.90
534395
33149+1246*1
-3439517.27717.39
633498
32311+1187*1
-3349816.82616.95
15min143331
41870+1461*1
-4333121.76521.263.5122.0821.563.50
240821
39362+1459*1
-4082120.50520.79
342708
41390+1318*1
-4270821.45321.77
444572
43046+1526*1
-4457222.38922.70
541489
40076+1413*1
-4148920.84021.14
640981
39590+1391*1
-4098120.58520.89
20min150793
49158+1635*1
-5079325.51424.024.1426.0724.564.11
246660
45016+1644*1
-4666023.43823.95
347273
45794+1479*1
-4727323.74624.30
449762
48016+1746*1
-4976224.99625.56
546384
44821+1563*1
-4638423.29923.83
646026
44466+1560*1
-4602623.11923.65
30min150905
48632+2273*1
-5090525.57023.515.9826.4124.325.89
244246
41933+2313*1
-4424622.22523.00
348122
45942+2180*1
-4812224.17224.99
448559
46191+2368*1
-4855924.39225.23
544054
41828+2226*1
-4405422.12922.92
644969
42753+2216*1
-4496922.58823.38
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min153807
50869+2938*1
-5380727.02825.175.1028.1526.245.05
248155
45123+3032*1
-4815524.18925.21
350694
47940+2754*1
-5069425.46426.55
452276
49174+3102*1
-5227626.25927.37
547842
44943+2899*1
-4784224.03125.07
647890
45068+2822*1
-4789024.05625.10
60min155795
51924+3871*1
-5579528.02626.504.3029.4527.854.29
250724
46818+3906*1
-5072425.47926.77
353383
49630+3753*1
-5338326.81528.19
454877
50762+4115*1
-5487727.56528.97
550506
46766+3740*1
-5050625.37026.67
651232
47535+3697*1
-5123225.73427.05
极限158104
53692+4412*1
-5810429.18627.154.8230.9228.804.78
252004
47503+4501*1
-5200426.12227.69
354435
50175+4260*1
-5443527.34329.01
455997
51325+4672*1
-5599728.12829.84
551868
47538+4330*1
-5186826.05427.64
651922
47687+4235*1
-5192226.08127.68
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%
1 18.15202189
202189+0
203084
203084+0
202207
202207+0
201241
201241+0
203212
203212+0
2023870.40
218.07201768
201768+0
202672
202672+0
2022200.32
单位质量响应值RSD%判断
11150.8011190.920.26数据可信
供试品溶液-2025010621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
10min12521
1889+632*1
-25211.2631.278.511.261.278.49
22342
1724+618*1
-23421.1731.17
32359
1749+610*1
-23591.1821.18
42941
2042+899*1
-29411.4741.47
52551
1937+614*1
-25511.2781.28
62551
1928+623*1
-25511.2781.28
15min13074
2261+813*1
-30741.5401.464.691.551.474.46
22702
2014+688*1
-27021.3541.37
32846
2175+671*1
-28461.4261.44
42859
2213+646*1
-28591.4321.45
53035
2351+684*1
-30351.5211.53
62923
2259+664*1
-29231.4641.48
20min13154
2419+735*1
-31541.5801.6718.531.611.7018.30
22961
2259+702*1
-29611.4841.51
32972
2253+719*1
-29721.4891.52
43116
2448+668*1
-31161.5611.59
54584
3814+770*1
-45842.2972.33
63267
2564+703*1
-32671.6371.67
30min13034
2277+757*1
-30341.5201.565.141.571.615.12
22883
2138+745*1
-28831.4441.49
33072
2314+758*1
-30721.5391.58
43219
2497+722*1
-32191.6131.66
53348
2605+743*1
-33481.6771.73
63125
2423+702*1
-31251.5661.61
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min13234
2413+821*1
-32341.6201.739.711.691.809.26
24101
3263+838*1
-41012.0552.12
33200
2470+730*1
-32001.6031.67
43517
2449+1068*1
-35171.7621.83
53370
2568+802*1
-33701.6881.76
63320
2539+781*1
-33201.6631.73
60min13341
2494+847*1
-33411.6741.632.491.761.722.32
23198
2313+885*1
-31981.6021.69
33169
2378+791*1
-31691.5881.67
43267
2440+827*1
-32671.6371.72
53214
2429+785*1
-32141.6101.70
63370
2556+814*1
-33701.6881.77
极限13482
2571+911*1
-34821.7451.737.471.851.837.20
23243
2334+909*1
-32431.6251.73
33257
2411+846*1
-32571.6321.73
43247
2404+843*1
-32471.6271.73
53552
2628+924*1
-35521.7801.89
63897
3002+895*1
-38971.9522.06
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%
1 18.15202540
202540+0
202505
202505+0
202766
202766+0
202106
202106+0
201813
201813+0
2023460.19
218.07200892
200892+0
200483
200483+0
2006880.15
单位质量响应值RSD%判断
11148.5411106.140.27数据可信
供试品溶液-2025010621批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117585
16835+750*1
-175858.8459.022.838.859.022.82
218169
17405+764*1
-181699.1399.14
318731
17955+776*1
-187319.4219.42
417537
16799+738*1
-175378.8218.82
518191
17456+735*1
-181919.1509.15
617429
16627+802*1
-174298.7678.77
10min130134
29039+1095*1
-3013415.15715.232.0915.2615.332.10
230410
29415+995*1
-3041015.29615.40
330502
29401+1101*1
-3050215.34215.45
429771
28659+1112*1
-2977114.97415.07
531320
30258+1062*1
-3132015.75415.86
629528
28476+1052*1
-2952814.85214.95
15min136606
35366+1240*1
-3660618.41218.171.7018.6818.441.68
236343
34802+1541*1
-3634318.28018.55
336936
35659+1277*1
-3693618.57818.85
435638
34391+1247*1
-3563817.92518.19
535321
34033+1288*1
-3532117.76618.04
635907
34606+1301*1
-3590718.06118.32
20min138979
37629+1350*1
-3897919.60619.861.4020.0820.331.39
239891
38455+1436*1
-3989120.06520.54
340092
38691+1401*1
-4009220.16620.65
438883
37566+1317*1
-3888319.55820.02
539931
38547+1384*1
-3993120.08520.56
639091
37694+1397*1
-3909119.66220.13
30min141819
40243+1576*1
-4181921.03421.591.8621.7222.291.83
242664
41028+1636*1
-4266421.45922.16
343881
42184+1697*1
-4388122.07222.78
443296
41656+1640*1
-4329621.77722.46
543607
41940+1667*1
-4360721.93422.63
642329
40706+1623*1
-4232921.29121.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min145488
43482+2006*1
-4548822.88022.761.5923.8023.681.49
244224
42303+1921*1
-4422422.24423.18
344869
42876+1993*1
-4486922.56823.52
445133
43147+1986*1
-4513322.70123.62
545334
43452+1882*1
-4533422.80223.74
646395
44291+2104*1
-4639523.33624.25
60min146132
43725+2407*1
-4613223.20423.430.8924.3824.620.88
246274
43999+2275*1
-4627423.27524.46
347011
44709+2302*1
-4701123.64624.85
446248
43959+2289*1
-4624823.26224.44
547028
44732+2296*1
-4702823.65424.85
646811
44467+2344*1
-4681123.54524.72
极限146020
43676+2344*1
-4602023.14723.841.4724.5825.281.41
247973
45455+2518*1
-4797324.13025.57
347689
45118+2571*1
-4768923.98725.45
447534
45050+2484*1
-4753423.90925.34
547644
45167+2477*1
-4764423.96425.42
647470
44980+2490*1
-4747023.87725.32
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