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%
119.07199386
199386+0		199612
199612+0		199658
199658+0		199304
199304+0		202053
202053+0		2000030.58
219.07199220
199220+0		199057
199057+0		1991380.06
单位质量响应值RSD%判断
10487.8310442.480.31数据可信
供试品溶液-12460835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%
5min138160
36516+2055*0.8		-3816019.10820.002.9919.1120.002.98
241479.2
39792+2109*0.8		-41479.220.77020.77
340708.8
39144+1956*0.8		-40708.820.38420.38
440379
38711+2085*0.8		-4037920.21920.22
539901.4
38291+2013*0.8		-39901.419.98019.98
639056
37520+1920*0.8		-3905619.55619.56
10min150036.2
48021+2519*0.8		-50036.225.05425.161.8625.2725.381.84
250082.4
48124+2448*0.8		-50082.425.07725.31
351678.2
49863+2269*0.8		-51678.225.87626.10
448829.8
47065+2206*0.8		-48829.824.45024.67
550203.4
48337+2333*0.8		-50203.425.13825.36
650693
48949+2180*0.8		-5069325.38325.60
15min153710
51570+2675*0.8		-5371026.89426.911.7627.3827.411.76
254028.2
51773+2819*0.8		-54028.227.05327.56
355144.8
53104+2551*0.8		-55144.827.61228.13
452495.8
50419+2596*0.8		-52495.826.28626.78
552928.6
50803+2657*0.8		-52928.626.50327.00
654168
52032+2670*0.8		-5416827.12327.62
20min153794.4
51524+2838*0.8		-53794.426.93627.101.8827.7327.901.83
255644.2
53385+2824*0.8		-55644.227.86228.67
354372.4
52146+2783*0.8		-54372.427.22628.05
454650.8
52422+2786*0.8		-54650.827.36528.15
553544.8
51348+2746*0.8		-53544.826.81127.61
652692.8
50616+2596*0.8		-52692.826.38427.19
30min153079.8
50207+3591*0.8		-53079.826.57826.392.7127.6727.492.64
253383.2
50368+3769*0.8		-53383.226.73027.85
354222
51482+3425*0.8		-5422227.15028.27
450012.6
47203+3512*0.8		-50012.625.04226.13
552861
49901+3700*0.8		-5286126.46927.56
652691.8
49783+3636*0.8		-52691.826.38427.48
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min153892
50500+4240*0.8		-5389226.98527.051.4928.3728.441.44
255294.8
51822+4341*0.8		-55294.827.68729.10
353701.6
50356+4182*0.8		-53701.626.89028.31
453360.8
49924+4296*0.8		-53360.826.71928.09
553224.8
49692+4416*0.8		-53224.826.65128.04
654648.6
51151+4372*0.8		-54648.627.36428.75
60min154009.6
50180+4787*0.8		-54009.627.04427.411.0128.7329.100.98
254847.8
50943+4881*0.8		-54847.827.46429.19
355040.4
51126+4893*0.8		-55040.427.56029.28
454857.6
50916+4927*0.8		-54857.627.46829.14
554175.6
50270+4882*0.8		-54175.627.12728.81
655473.2
51514+4949*0.8		-55473.227.77729.47
极限153896.2
49789+5134*0.8		-53896.226.98727.411.7628.9729.411.65
255768.2
51649+5149*0.8		-55768.227.92429.95
354717.2
50638+5099*0.8		-54717.227.39829.43
455969.2
51774+5244*0.8		-55969.228.02530.00
554525
50273+5315*0.8		-5452527.30229.29
653595
49599+4995*0.8		-5359526.83628.84
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%
119.07197207
197207+0		196779
196779+0		196350
196350+0		196509
196509+0		195960
195960+0		1965610.24
219.07199025
199025+0		198489
198489+0		1987570.20
单位质量响应值RSD%判断
10307.3410422.500.79数据可信
供试品溶液-12460835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%
5min140215.6
38630+1982*0.8		-40215.620.33220.851.7320.3320.851.73
241980.6
40199+2227*0.8		-41980.621.22421.22
340752.4
39058+2118*0.8		-40752.420.60420.60
440980.4
39478+1878*0.8		-40980.420.71920.72
541977.8
40305+2091*0.8		-41977.821.22321.22
641540.2
39825+2144*0.8		-41540.221.00221.00
10min152256
50228+2535*0.8		-5225626.42026.190.5926.6526.420.58
251725
49673+2565*0.8		-5172526.15126.39
351612.2
49733+2349*0.8		-51612.226.09426.32
452077
50153+2405*0.8		-5207726.32926.56
551549
49657+2365*0.8		-5154926.06226.30
651534.4
49688+2308*0.8		-51534.426.05526.29
15min153023.8
50867+2696*0.8		-53023.826.80827.391.5027.3327.911.48
253932.4
51894+2548*0.8		-53932.427.26727.79
354119.8
52043+2596*0.8		-54119.827.36227.88
455012.8
52868+2681*0.8		-55012.827.81328.34
553765.6
51532+2792*0.8		-53765.627.18327.71
655191.6
53070+2652*0.8		-55191.627.90428.43
20min156103
53747+2945*0.8		-5610328.36428.521.6329.1829.341.58
257105.8
54809+2871*0.8		-57105.828.87129.70
357210.6
54901+2887*0.8		-57210.628.92429.75
454929.2
52618+2889*0.8		-54929.227.77128.60
557148.6
54671+3097*0.8		-57148.628.89329.72
655911.2
53532+2974*0.8		-55911.228.26829.10
30min155049.2
51926+3904*0.8		-55049.227.83226.992.1228.9628.142.01
252905.8
49989+3646*0.8		-52905.826.74827.90
353957.6
51040+3647*0.8		-53957.627.28028.42
452973
49977+3745*0.8		-5297326.78227.92
551732
48852+3600*0.8		-5173226.15527.30
653736.8
50736+3751*0.8		-53736.827.16828.32
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min153690
50306+4230*0.8		-5369027.14527.501.4328.5928.941.35
253958.2
50643+4144*0.8		-53958.227.28028.73
355454.2
51883+4464*0.8		-55454.228.03629.48
455196.6
51631+4457*0.8		-55196.627.90629.34
553653.2
50322+4164*0.8		-53653.227.12628.56
654417.2
50914+4379*0.8		-54417.227.51228.96
60min154738
50886+4815*0.8		-5473827.67427.850.8129.4229.600.76
254681
50729+4940*0.8		-5468127.64629.40
355140
51216+4905*0.8		-5514027.87829.64
454697.8
50857+4801*0.8		-54697.827.65429.40
555681.8
51713+4961*0.8		-55681.828.15229.89
655523
51619+4880*0.8		-5552328.07129.83
极限153627.8
49511+5146*0.8		-53627.827.11327.731.3629.1629.791.27
255969.8
51605+5456*0.8		-55969.828.29730.35
354884.2
50685+5249*0.8		-54884.227.74829.82
454957.2
50814+5179*0.8		-54957.227.78529.84
554888.4
50686+5253*0.8		-54888.427.75029.80
654779.2
50724+5069*0.8		-54779.227.69529.76
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