XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110185458
185332
185294
185286
185405
1853550.05
210185961
185757
1858590.08
单位质量响应值RSD%判断
18535.5018585.900.20数据可信
供试品溶液-20211122批-111-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14795
-47952.5832.2311.502.582.2311.53
24133
-41332.2272.23
34267
-42672.2992.30
44413
-44132.3782.38
53830
-38302.0642.06
63418
-34181.8421.84
10min19523
-95235.1314.933.195.144.933.23
29341
-93415.0335.04
39216
-92164.9654.97
49166
-91664.9384.94
58811
-88114.7474.75
68793
-87934.7374.74
15min111316
-113166.0975.953.466.115.973.48
210630
-106305.7275.74
311567
-115676.2326.25
411255
-112556.0646.08
510679
-106795.7545.77
610861
-108615.8525.86
20min112824
-128246.9096.742.886.946.772.87
212518
-125186.7446.77
312891
-128916.9456.97
412588
-125886.7826.81
512350
-123506.6546.68
611899
-118996.4116.44
30min113402
-134027.2217.182.137.267.222.14
213220
-132207.1237.16
313694
-136947.3787.42
413472
-134727.2587.30
513319
-133197.1767.21
612850
-128506.9236.96
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min115333
-153338.2618.083.318.328.143.30
214063
-140637.5777.63
314998
-149988.0818.14
415244
-152448.2138.27
515424
-154248.3108.36
614956
-149568.0588.11
60min115814
-158148.5208.471.918.598.541.91
215924
-159248.5798.65
316048
-160488.6468.72
415269
-152698.2278.30
515848
-158488.5388.61
615450
-154508.3248.39
极限116063
-160638.6548.722.318.748.812.28
215650
-156508.4328.52
316109
-161098.6798.77
416804
-168049.0549.14
516264
-162648.7638.85
616205
-162058.7318.82
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
125430986
430986+0		431529
431529+0		431172
431172+0		431209
431209+0		431031
431031+0		4311850.05
225431606
431606+0		431722
431722+0		4316640.02
单位质量响应值RSD%判断
17247.4017266.560.08数据可信
供试品溶液-20211122批-222-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min110621
6169+4452*1		-106212.4621.7926.962.461.7927.03
27595
4243+3352*1		-75951.7601.76
39007
5099+3908*1		-90072.0882.09
47603
4211+3392*1		-76031.7621.76
57290
4079+3211*1		-72901.6901.69
64330
2303+2027*1		-43301.0041.00
10min131822
17738+14084*1		-318227.3766.983.987.386.983.98
231087
17364+13723*1		-310877.2067.21
328890
15916+12974*1		-288906.6966.70
428928
15892+13036*1		-289286.7056.71
530396
16770+13626*1		-303967.0457.05
629565
16287+13278*1		-295656.8536.85
15min144362
23896+20466*1		-4436210.2839.677.0410.309.697.03
237461
20089+17372*1		-374618.6838.70
344427
23934+20493*1		-4442710.29810.32
443776
23452+20324*1		-4377610.14710.16
539258
20889+18369*1		-392589.1009.12
641090
22106+18984*1		-410909.5249.54
20min153647
27964+25683*1		-5364712.43512.093.8412.4812.133.85
252745
27544+25201*1		-5274512.22612.26
354659
28094+26565*1		-5465912.66912.71
451341
26828+24513*1		-5134111.90011.94
551702
26780+24922*1		-5170211.98412.02
648941
25612+23329*1		-4894111.34411.38
30min160126
30248+29878*1		-6012613.93714.131.6114.0014.191.60
259906
29792+30114*1		-5990613.88613.95
361473
30305+31168*1		-6147314.24914.31
461217
30256+30961*1		-6121714.19014.25
562512
31034+31478*1		-6251214.49014.55
660464
29902+30562*1		-6046414.01514.07
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min178454
34265+44189*1		-7845418.18517.904.8118.2817.994.79
272209
31249+40960*1		-7220916.73716.82
377148
33478+43670*1		-7714817.88217.97
475718
32270+43448*1		-7571817.55117.64
583493
36455+47038*1		-8349319.35319.44
676449
33181+43268*1		-7644917.72017.81
60min190351
39772+50579*1		-9035120.94220.724.1121.0720.844.08
291288
40013+51275*1		-9128821.16021.28
394574
41569+53005*1		-9457421.92122.05
483755
36507+47248*1		-8375519.41419.54
588795
38761+50034*1		-8879520.58220.71
687473
38298+49175*1		-8747320.27520.40
极限196702
42944+53758*1		-9670222.41522.313.1022.5922.483.09
291382
40429+50953*1		-9138221.18121.34
398411
43503+54908*1		-9841122.81122.98
499668
43916+55752*1		-9966823.10223.27
594372
41497+52875*1		-9437221.87522.04
697082
42662+54420*1		-9708222.50322.66
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