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%
119.22207662
207662+0		207170
207170+0		207578
207578+0		207483
207483+0		207177
207177+0		2074140.12
219.03201519
201519+0		202858
202858+0		2021880.47
单位质量响应值RSD%判断
10791.5710624.701.11数据可信
供试品溶液-2023082021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%
5min125240
25240+0		-2524012.35212.638.4712.3512.638.48
228930
28930+0		-2893014.15814.16
326431
26431+0		-2643112.93512.94
425800
25800+0		-2580012.62612.63
522177
22177+0		-2217710.85310.85
626233
26233+0		-2623312.83812.84
10min144360
44360+0		-4436021.70922.123.2121.8522.263.24
246943
46943+0		-4694322.97323.13
345912
45912+0		-4591222.46922.61
445966
45966+0		-4596622.49522.64
542822
42822+0		-4282220.95721.08
645131
45131+0		-4513122.08722.23
15min152707
52707+0		-5270725.79425.902.2726.1726.292.30
254840
54840+0		-5484026.83827.25
353763
53763+0		-5376326.31126.70
452487
52487+0		-5248725.68726.08
551416
51416+0		-5141625.16225.52
652373
52373+0		-5237325.63126.02
20min158074
58074+0		-5807428.42128.791.6529.0929.461.69
260074
60074+0		-6007429.40030.11
359891
59891+0		-5989129.31030.00
458913
58913+0		-5891328.83129.51
557918
57918+0		-5791828.34428.98
658050
58050+0		-5805028.40929.08
30min160504
60504+0		-6050429.61030.051.4230.5931.051.41
261238
61238+0		-6123829.96931.01
361831
61831+0		-6183130.25931.27
461881
61881+0		-6188130.28431.28
560387
60387+0		-6038729.55330.50
662622
62622+0		-6262230.64631.63
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min167633.8
63313+5401*0.8		-67633.833.09933.411.1334.4134.741.17
269303
64859+5555*0.8		-6930333.91635.29
369060.8
64788+5341*0.8		-69060.833.79835.15
468343
64155+5235*0.8		-6834333.44634.78
567706.2
63599+5134*0.8		-67706.233.13534.41
667551.2
63312+5299*0.8		-67551.233.05934.39
60min167349.6
62472+6097*0.8		-67349.632.96033.911.8134.6435.611.79
270426.4
65228+6498*0.8		-70426.434.46636.21
370827.4
65801+6283*0.8		-70827.434.66236.39
468631
63687+6180*0.8		-6863133.58735.29
569252
64352+6125*0.8		-6925233.89135.54
669244.2
64177+6334*0.8		-69244.233.88735.58
极限168259.4
62737+6903*0.8		-68259.433.40533.991.1935.4536.071.17
270388
64788+7000*0.8		-7038834.44736.58
369732.2
64273+6824*0.8		-69732.234.12636.23
468718.2
63459+6574*0.8		-68718.233.63035.71
570147.4
64701+6808*0.8		-70147.434.32936.35
669500.8
64040+6826*0.8		-69500.834.01336.09
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%
119.22203716
203716+0		204917
204917+0		205144
205144+0		204164
204164+0		203928
203928+0		2043740.31
219.03205751
205751+0		204702
204702+0		2052260.37
单位质量响应值RSD%判断
10633.4010784.341.00数据可信
供试品溶液-t2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%
5min124917
24917+0		-2491712.19312.633.2912.1912.633.30
224952
24952+0		-2495212.21012.21
327035
27035+0		-2703513.23013.23
425620
25620+0		-2562012.53712.54
525820
25820+0		-2582012.63512.64
626536
26536+0		-2653612.98512.99
10min143487
43487+0		-4348721.28021.582.8821.4221.722.88
242783
42783+0		-4278320.93621.07
346419
46419+0		-4641922.71522.86
443391
43391+0		-4339121.23321.37
544295
44295+0		-4429521.67621.82
644162
44162+0		-4416221.61121.75
15min151099
51099+0		-5109925.00525.231.3425.3825.611.36
250442
50442+0		-5044224.68425.05
352194
52194+0		-5219425.54125.94
451691
51691+0		-5169125.29525.67
552253
52253+0		-5225325.57025.95
651689
51689+0		-5168925.29425.68
20min156881
56881+0		-5688127.83527.841.6928.4828.501.68
255779
55779+0		-5577927.29527.94
358038
58038+0		-5803828.40129.08
456501
56501+0		-5650127.64928.31
558045
58045+0		-5804528.40429.07
656156
56156+0		-5615627.48028.15
30min158998
58998+0		-5899828.87129.342.7729.8330.322.71
259238
59238+0		-5923828.98829.93
359876
59876+0		-5987629.30030.30
458942
58942+0		-5894228.84329.81
563280.8
59204+5096*0.8		-63280.830.96631.95
659470
59470+0		-5947029.10230.07
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min165899.2
61244+5819*0.8		-65899.232.24832.480.7733.5333.780.80
265937.8
61321+5771*0.8		-65937.832.26733.53
366664.6
62131+5667*0.8		-66664.632.62233.95
466236.8
61736+5626*0.8		-66236.832.41333.70
567251.2
62372+6099*0.8		-67251.232.90934.23
666312.4
61838+5593*0.8		-66312.432.45033.74
60min169241.4
63619+7028*0.8		-69241.433.88333.191.9235.5234.851.81
268520.6
62999+6902*0.8		-68520.633.53135.16
368881.6
63556+6657*0.8		-68881.633.70735.39
466486.8
61326+6451*0.8		-66486.832.53534.18
566069
60677+6740*0.8		-6606932.33134.02
667794
62466+6660*0.8		-6779433.17534.83
极限170878
64722+7695*0.8		-7087834.68433.651.8536.7035.681.70
268613.6
62768+7307*0.8		-68613.633.57635.58
367202.2
61435+7209*0.8		-67202.232.88534.95
468895.6
63002+7367*0.8		-68895.633.71435.72
567796.4
61814+7478*0.8		-67796.433.17635.23
669173
63497+7095*0.8		-6917333.85035.87
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%
119.22202088
202088+0		201154
201154+0		200476
200476+0		200583
200583+0		200762
200762+0		2010130.33
219.03195436
195436+0		196366
196366+0		1959010.34
单位质量响应值RSD%判断
10458.5310294.321.12数据可信
供试品溶液-2023082121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%
5min129059
29059+0		-2905914.67615.054.5814.6815.054.57
230838
30838+0		-3083815.57415.57
330294
30294+0		-3029415.29915.30
427363
27363+0		-2736313.81913.82
530311
30311+0		-3031115.30815.31
630905
30905+0		-3090515.60815.61
10min145242
45242+0		-4524222.84923.552.0323.0123.722.03
247256
47256+0		-4725623.86624.04
347847
47847+0		-4784724.16424.33
446433
46433+0		-4643323.45023.60
545981
45981+0		-4598123.22223.39
647056
47056+0		-4705623.76523.94
15min154525
54525+0		-5452527.53727.202.0927.9527.632.05
252198
52198+0		-5219826.36226.80
354096
54096+0		-5409627.32027.76
454034
54034+0		-5403427.28927.70
552948
52948+0		-5294826.74127.17
655339
55339+0		-5533927.94828.39
20min156978
56978+0		-5697828.77629.214.0629.5029.944.00
257487
57487+0		-5748729.03329.76
358156
58156+0		-5815629.37130.11
456598
56598+0		-5659828.58429.30
555523
55523+0		-5552328.04128.77
662273.2
58150+5154*0.8		-62273.231.45032.20
30min166281.8
62141+5176*0.8		-66281.833.47532.654.0934.5233.713.98
265163.4
60825+5423*0.8		-65163.432.91033.96
366515.8
62251+5331*0.8		-66515.833.59334.66
466176.2
61957+5274*0.8		-66176.233.42134.46
559556
59556+0		-5955630.07831.11
664250.2
59819+5539*0.8		-64250.232.44933.55
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min167881.2
63110+5964*0.8		-67881.234.28234.621.7835.7036.041.75
269115.6
64126+6237*0.8		-69115.634.90636.33
369002.4
64100+6128*0.8		-69002.434.84936.29
470198.4
65084+6393*0.8		-70198.435.45336.86
566634.4
62500+5168*0.8		-66634.433.65335.02
668420.6
63171+6562*0.8		-68420.634.55536.01
60min167895.2
62320+6969*0.8		-67895.234.28935.292.4236.0837.092.34
271848.4
66030+7273*0.8		-71848.436.28638.09
371983
66127+7320*0.8		-7198336.35438.18
469715.8
64095+7026*0.8		-69715.835.20937.01
568682.6
63609+6342*0.8		-68682.634.68736.43
669139.6
63062+7597*0.8		-69139.634.91836.76
极限169793
63877+7395*0.8		-6979335.24835.351.2237.4237.551.19
269092.2
63101+7489*0.8		-69092.234.89437.10
370850
64762+7610*0.8		-7085035.78238.01
471241.2
64906+7919*0.8		-71241.235.97938.17
569369.4
63715+7068*0.8		-69369.435.03437.16
669679.2
63312+7959*0.8		-69679.235.19037.42
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