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%
119.22205587
205488
205434
204234
204780
2051050.29
219.03198992
198766
1988790.09
单位质量响应值RSD%判断
10671.4410450.811.48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%
5min116601
-166018.2388.853.708.248.853.70
217773
-177738.8198.82
318127
-181278.9959.00
418554
-185549.2079.21
517889
-178898.8778.88
618043
-180438.9538.95
10min130621
-3062115.19515.531.3315.2915.631.33
231430
-3143015.59615.69
331176
-3117615.47015.57
431474
-3147415.61815.72
531880
-3188015.82015.92
631235
-3123515.50015.60
15min136712
-3671218.21718.561.3918.4818.831.39
237291
-3729118.50518.78
338141
-3814118.92719.20
437560
-3756018.63818.91
537693
-3769318.70418.98
636963
-3696318.34218.61
20min140344
-4034420.02020.211.5520.4820.691.52
240785
-4078520.23920.72
341921
-4192120.80221.28
440750
-4075020.22120.70
540409
-4040920.05220.53
640185
-4018519.94120.42
30min144529
-4452922.09622.301.3922.7823.001.36
244510
-4451022.08722.79
345968
-4596822.81023.52
444337
-4433722.00122.71
545338
-4533822.49823.20
644904
-4490422.28222.98
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min146176
-4617622.91423.561.5723.8424.511.55
247967
-4796723.80224.75
347991
-4799123.81424.78
448178
-4817823.90724.86
547274
-4727423.45924.41
647298
-4729823.47024.42
60min148145
-4814523.89124.130.9025.0825.340.89
248016
-4801623.82725.04
348907
-4890724.26925.50
448995
-4899524.31325.53
548712
-4871224.17225.39
648970
-4897024.30025.51
极限147220
-4722023.43223.891.4224.8825.361.38
248091
-4809123.86425.34
348199
-4819923.91825.42
448671
-4867124.15225.64
549070
-4907024.35025.83
647571
-4757123.60625.08
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%
119.22202176
201638
201587
201527
201056
2015970.20
219.03197049
197201
1971250.06
单位质量响应值RSD%判断
10488.9210358.640.89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%
5min117467
-174678.7818.952.718.788.952.71
218501
-185019.3019.30
317737
-177378.9178.92
417206
-172068.6508.65
518235
-182359.1679.17
617699
-176998.8988.90
10min130815
-3081515.49215.551.5115.5915.651.52
231600
-3160015.88615.99
331369
-3136915.77015.87
430583
-3058315.37515.47
530838
-3083815.50315.60
630380
-3038015.27315.37
15min136614
-3661418.40718.633.0918.6818.903.06
238745
-3874519.47819.76
337795
-3779519.00119.27
435368
-3536817.78018.05
536755
-3675518.47818.75
637062
-3706218.63218.90
20min140958
-4095820.59120.390.8921.0620.870.91
240878
-4087820.55121.05
340790
-4079020.50620.99
440053
-4005320.13620.60
540364
-4036420.29220.77
640354
-4035420.28720.76
30min144330
-4433022.28622.451.2722.9923.161.28
245477
-4547722.86323.59
345183
-4518322.71523.43
443996
-4399622.11822.81
544330
-4433022.28622.99
644656
-4465622.45023.15
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min147663
-4766323.96223.561.9724.9124.511.94
247501
-4750123.88024.86
347734
-4773423.99724.96
445509
-4550922.87923.81
546134
-4613423.19324.15
646609
-4660923.43224.38
60min148149
-4814924.20623.971.7325.4225.191.69
248911
-4891124.58925.83
347866
-4786624.06425.30
447581
-4758123.92025.11
546831
-4683123.54324.75
646751
-4675123.50324.71
极限147834
-4783424.04724.090.6225.5325.570.67
248286
-4828624.27525.79
348171
-4817124.21725.72
447642
-4764223.95125.40
548037
-4803724.15025.62
647546
-4754623.90325.37
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%
119.22198191
197643
197601
197506
197846
1977570.14
219.03193426
193409
1934180.01
单位质量响应值RSD%判断
10289.1310163.850.87数据可信
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%
5min119811
-1981110.15210.202.8710.1510.202.89
220270
-2027010.38710.39
320560
-2056010.53510.54
420336
-2033610.42110.42
519203
-192039.8409.84
619287
-192879.8839.88
10min132334
-3233416.56916.481.7216.6816.601.71
232456
-3245616.63116.75
332756
-3275616.78516.90
431869
-3186916.33116.45
532379
-3237916.59216.70
631203
-3120315.98916.10
15min137104
-3710419.01319.190.7119.3119.480.72
237506
-3750619.21919.52
337831
-3783119.38619.69
437347
-3734719.13819.43
537616
-3761619.27519.57
637243
-3724319.08419.37
20min141287
-4128721.15721.321.9021.6621.831.86
240682
-4068220.84721.36
342357
-4235721.70522.22
441234
-4123421.12921.64
542777
-4277721.92022.43
641332
-4133221.18021.68
30min146071
-4607123.60823.191.4224.3523.941.36
244858
-4485822.98623.73
344288
-4428822.69423.45
445247
-4524723.18623.93
545782
-4578223.46024.21
645278
-4527823.20223.94
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min146438
-4643823.79624.181.8824.8025.181.81
246277
-4627723.71424.71
347535
-4753524.35825.37
446568
-4656823.86324.86
547938
-4793824.56525.58
648389
-4838924.79625.79
60min147923
-4792324.55724.701.8725.8325.971.79
249060
-4906025.14026.40
348134
-4813424.66525.95
446670
-4667023.91525.18
549125
-4912525.17326.46
648303
-4830324.75226.02
极限148218
-4821824.70824.881.4426.2526.431.33
248766
-4876624.98926.53
348779
-4877924.99626.55
448747
-4874724.97926.51
547396
-4739624.28725.85
649473
-4947325.35126.89
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