尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
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%
110200804
200804+0
200455
200455+0
200250
200250+0
200392
200392+0
200489
200489+0
2004780.11
210201902
201902+0
201953
201953+0
2019280.02
单位质量响应值RSD%判断
20047.8020192.800.51数据可信
长期3月-供试品溶液-20211122批-80mg规格-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%
5min167081
62600+4481*1
-6708133.34035.526.8133.3435.526.81
271139
66484+4655*1
-7113935.35735.36
379185
74274+4911*1
-7918539.35639.36
474666
69773+4893*1
-7466637.11037.11
570596
66301+4295*1
-7059635.08735.09
666148
61975+4173*1
-6614832.87732.88
10min1126578
118135+8443*1
-12657862.91164.962.7663.2465.322.77
2132763
123699+9064*1
-13276365.98566.34
3136447
127165+9282*1
-13644767.81668.21
4130521
121778+8743*1
-13052164.87165.24
5127501
118983+8518*1
-12750163.37063.72
6130430
121473+8957*1
-13043064.82665.15
15min1155758
143930+11828*1
-15575877.41479.131.8178.3880.131.82
2161879
149501+12378*1
-16187980.45781.47
3162945
150628+12317*1
-16294580.98682.06
4157739
145760+11979*1
-15773978.39979.42
5156882
145188+11694*1
-15688277.97378.96
6160019
148183+11836*1
-16001979.53280.51
20min1175157
160029+15128*1
-17515787.05687.650.7888.7989.450.79
2176291
161226+15065*1
-17629187.62089.44
3177472
162219+15253*1
-17747288.20790.09
4175089
160338+14751*1
-17508987.02288.83
5175669
160938+14731*1
-17566987.31089.07
6178484
163430+15054*1
-17848488.71090.48
30min1181085
154448+26637*1
-18108590.00293.042.3192.6195.722.27
2184312
156914+27398*1
-18431291.60694.30
3188181
160004+28177*1
-18818193.52996.29
4190085
161807+28278*1
-19008594.47597.15
5186258
159086+27172*1
-18625892.57395.21
6193307
165134+28173*1
-19330796.07798.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1191858
155402+36456*1
-19185895.35796.220.9098.8699.820.91
2195050
157744+37306*1
-19505096.943100.55
3193909
156623+37286*1
-19390996.376100.07
4193434
156633+36801*1
-19343496.14099.76
5191469
155448+36021*1
-19146995.16398.73
6195897
159033+36864*1
-19589797.364100.98
60min1184244
136200+48044*1
-18424491.57294.552.0696.0399.121.99
2190629
140668+49961*1
-19062994.74699.33
3187850
138646+49204*1
-18785093.36598.03
4190866
141165+49701*1
-19086694.86499.44
5192092
142187+49905*1
-19209295.47399.99
6195785
144947+50838*1
-19578597.308101.90
极限1190546
135885+54661*1
-19054694.70595.410.94100.08100.920.95
2191529
136074+55455*1
-19152995.193100.72
3193818
137597+56221*1
-19381896.331101.93
4192300
137013+55287*1
-19230095.576101.11
5189550
135569+53981*1
-18955094.21099.68
6194074
138667+55407*1
-19407496.458102.03
尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
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%
110201108
201108+0
201332
201332+0
201257
201257+0
201002
201002+0
201071
201071+0
2011540.07
210201395
201395+0
201931
201931+0
2016630.19
单位质量响应值RSD%判断
20115.4020166.300.18数据可信
长期3月-供试品溶液-20211122批-80mg规格-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%
5min167691
63215+4476*1
-6769133.60937.026.4233.6137.026.42
274258
69509+4749*1
-7425836.86936.87
381447
76013+5434*1
-8144740.43940.44
471735
67117+4618*1
-7173535.61735.62
574253
69166+5087*1
-7425336.86736.87
677966
72913+5053*1
-7796638.71038.71
10min1126706
118081+8625*1
-12670662.91066.783.0763.2567.153.08
2136944
127535+9409*1
-13694467.99368.36
3138599
128897+9702*1
-13859968.81569.22
4135742
126387+9355*1
-13574267.39667.75
5134545
125102+9443*1
-13454566.80267.17
6134477
125286+9191*1
-13447766.76867.16
15min1156615
144344+12271*1
-15661577.76080.902.5378.7381.942.53
2160104
147543+12561*1
-16010479.49280.54
3167307
153818+13489*1
-16730783.06984.16
4162533
149883+12650*1
-16253380.69881.73
5164222
151258+12964*1
-16422281.53782.57
6166867
153933+12934*1
-16686782.85083.90
20min1173866
158675+15191*1
-17386686.32588.762.3388.0790.612.32
2176538
160904+15634*1
-17653887.65289.50
3179675
163677+15998*1
-17967589.20991.13
4176955
161292+15663*1
-17695587.85989.70
5186036
169476+16560*1
-18603692.36894.22
6179519
163675+15844*1
-17951989.13291.02
30min1179488
152235+27253*1
-17948889.11793.972.7591.7296.702.72
2190540
161668+28872*1
-19054094.60497.32
3187599
159015+28584*1
-18759993.14495.96
4193017
163996+29021*1
-19301795.83498.55
5192580
163541+29039*1
-19258095.61798.39
6192371
163926+28445*1
-19237195.51398.29
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1185187
149421+35766*1
-18518791.94696.412.6795.44100.082.65
2193239
155787+37452*1
-19323995.94499.61
3193576
155765+37811*1
-19357696.11199.86
4198820
160448+38372*1
-19882098.715102.39
5194482
156901+37581*1
-19448296.561100.29
6199713
161567+38146*1
-19971399.158102.89
60min1184791
136063+48728*1
-18479191.75095.742.4596.17100.382.44
2189956
139555+50401*1
-18995694.31498.94
3193092
141832+51260*1
-19309295.871100.58
4196183
144798+51385*1
-19618397.406102.07
5197095
145576+51519*1
-19709597.858102.56
6195867
145004+50863*1
-19586797.249101.97
极限1184640
131029+53611*1
-18464091.67596.873.1997.01102.473.14
2191589
135728+55861*1
-19158995.125100.69
3194740
137768+56972*1
-19474096.689102.36
4198756
140972+57784*1
-19875698.683104.32
5200128
142141+57987*1
-20012899.364105.04
6200798
142916+57882*1
-20079899.697105.39
尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
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%
110200435
200435+0
200872
200872+0
201030
201030+0
200829
200829+0
200203
200203+0
2006740.18
210200666
200666+0
200695
200695+0
2006800.02
单位质量响应值RSD%判断
20067.4020068.000.01数据可信
长期3月-供试品溶液-20211122批-80mg规格-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%
5min194691
88931+5760*1
-9469147.18649.313.1347.1949.313.13
295517
89605+5912*1
-9551747.59747.60
3101667
95633+6034*1
-10166750.66250.66
4100185
93951+6234*1
-10018549.92449.92
5101820
95509+6311*1
-10182050.73850.74
699833
93721+6112*1
-9983349.74849.75
10min1147779
137717+10062*1
-14777973.64073.431.5474.1173.921.54
2144967
135241+9726*1
-14496772.23972.71
3150374
140202+10172*1
-15037474.93375.44
4148625
138491+10134*1
-14862574.06274.56
5148002
138140+9862*1
-14800273.75174.26
6144407
134754+9653*1
-14440771.96072.46
15min1167172
154284+12888*1
-16717283.30484.181.0784.5185.401.07
2167147
154344+12803*1
-16714783.29284.49
3171368
158241+13127*1
-17136885.39586.65
4168465
155430+13035*1
-16846583.94885.19
5168555
155481+13074*1
-16855583.99385.24
6170824
157882+12942*1
-17082485.12486.34
20min1177897
162218+15679*1
-17789788.64890.131.7590.6992.201.71
2182904
166537+16367*1
-18290491.14393.17
3180292
164011+16281*1
-18029289.84291.95
4179916
163810+16106*1
-17991689.65591.73
5178093
162253+15840*1
-17809388.74690.83
6186147
169777+16370*1
-18614792.76094.83
30min1172554
144877+27677*1
-17255485.98691.623.8288.9194.593.72
2183261
153082+30179*1
-18326191.32194.26
3187037
156495+30542*1
-18703793.20396.21
4182776
152687+30089*1
-18277691.08094.06
5183351
153231+30120*1
-18335191.36694.34
6194148
162603+31545*1
-19414896.74799.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1184576
147759+36817*1
-18457691.97793.011.7595.7696.901.72
2188684
149793+38891*1
-18868494.02497.88
3187377
149205+38172*1
-18737793.37297.31
4187293
148865+38428*1
-18729393.33197.22
5181339
144357+36982*1
-18133990.36494.25
6190608
152284+38324*1
-19060894.98298.95
60min1186296
137187+49109*1
-18629692.83494.842.3297.5499.662.26
2183610
134039+49571*1
-18361091.49596.29
3191196
140107+51089*1
-19119695.275100.15
4192567
141368+51199*1
-19256795.959100.78
5193485
141922+51563*1
-19348596.416101.21
6194829
142915+51914*1
-19482997.086102.00
极限1187808
134220+53588*1
-18780893.58794.510.8199.22100.270.81
2191169
135518+55651*1
-19116995.262100.97
3190959
135240+55719*1
-19095995.157100.98
4188103
133962+54141*1
-18810393.73499.51
5189053
135927+53126*1
-18905394.20899.96
6190863
135863+55000*1
-19086395.110100.99
尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
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%
110201099
201099+0
200858
200858+0
201115
201115+0
201138
201138+0
200875
200875+0
2010170.07
210199283
199283+0
199482
199482+0
1993820.08
单位质量响应值RSD%判断
20101.7019938.200.58数据可信
长期3月-供试品溶液-20211122批-80mg规格-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%
5min189636
83516+6120*1
-8963644.77447.964.1544.7747.964.15
295773
89102+6671*1
-9577347.84047.84
3102147
95244+6903*1
-10214751.02351.02
496343
89763+6580*1
-9634348.12448.12
596608
89995+6613*1
-9660848.25748.26
695529
89165+6364*1
-9552947.71847.72
10min1143068
132342+10726*1
-14306871.46472.613.0071.9173.092.98
2149730
138291+11439*1
-14973074.79275.27
3144148
133222+10926*1
-14414872.00372.51
4151842
140455+11387*1
-15184275.84776.33
5141419
130718+10701*1
-14141970.64071.12
6141983
131463+10520*1
-14198370.92271.40
15min1162088
148183+13905*1
-16208880.96584.312.6582.1385.522.64
2167932
153644+14288*1
-16793283.88485.11
3173192
158285+14907*1
-17319286.51187.74
4172968
158205+14763*1
-17296886.39987.64
5171158
156482+14676*1
-17115885.49586.68
6165374
151469+13905*1
-16537482.60683.79
20min1178032
161032+17000*1
-17803288.92990.842.0490.9092.892.02
2185833
167884+17949*1
-18583392.82594.89
3178024
160699+17325*1
-17802488.92591.02
4186303
168387+17916*1
-18630393.06095.16
5182772
165138+17634*1
-18277291.29693.34
6180205
163189+17016*1
-18020590.01492.03
30min1173431
144642+28789*1
-17343186.63191.393.1789.4994.343.14
2185992
154997+30995*1
-18599292.90595.90
3185905
155024+30881*1
-18590592.86195.85
4188012
157180+30832*1
-18801293.91496.95
5186225
155587+30638*1
-18622593.02195.98
6178137
149293+28844*1
-17813788.98191.89
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1186945
148627+38318*1
-18694593.38195.331.5997.1199.201.60
2189250
150044+39206*1
-18925094.53298.45
3193224
153540+39684*1
-19322496.517100.43
4194705
154581+40124*1
-19470597.257101.23
5192375
152845+39530*1
-19237596.09399.98
6188592
150833+37759*1
-18859294.20498.01
60min1177879
130443+47436*1
-17787988.85294.153.6193.5198.983.51
2182330
132953+49377*1
-18233091.07695.94
3192670
141082+51588*1
-19267096.241101.12
4194462
142244+52218*1
-19446297.136102.08
5193460
142054+51406*1
-19346096.635101.48
6190134
140512+49622*1
-19013494.97499.72
极限1188705
134551+54154*1
-18870594.26095.811.3799.81101.571.35
2188709
132934+55775*1
-18870994.262100.04
3193291
136677+56614*1
-19329196.551102.39
4192864
136576+56288*1
-19286496.338102.25
5191985
136851+55134*1
-19198595.898101.71
6195249
139616+55633*1
-19524997.529103.22
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