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%
119.23205727
205727+0		205820
205820+0		205489
205489+0		204912
204912+0		204693
204693+0		2053280.25
219.28206585
206585+0		206329
206329+0		2064570.09
单位质量响应值RSD%判断
10677.4810708.350.21数据可信
中间条件12月-供试品溶液-2023082621批-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%
5min184608
79396+6515*0.8		-8460841.46341.972.8541.4641.972.85
286675.2
81076+6999*0.8		-86675.242.47642.48
383642.4
78524+6398*0.8		-83642.440.98940.99
487945.8
82629+6646*0.8		-87945.843.09843.10
588489.2
82518+7464*0.8		-88489.243.36543.36
682462.8
76866+6996*0.8		-82462.840.41140.41
10min1133507.2
122600+13634*0.8		-133507.265.42667.953.2465.8968.423.23
2135769
124057+14640*0.8		-13576966.53467.01
3135233.6
123788+14307*0.8		-135233.666.27266.73
4144390
135090+11625*0.8		-14439070.75971.24
5143107.4
133469+12048*0.8		-143107.470.13170.61
6139904.4
130794+11388*0.8		-139904.468.56169.01
15min1156822.4
142940+17353*0.8		-156822.476.85279.902.2378.0481.122.23
2162231.8
150527+14631*0.8		-162231.879.50380.71
3164353.4
152739+14518*0.8		-164353.480.54281.73
4167975.6
155966+15012*0.8		-167975.682.31783.58
5162986.8
151114+14841*0.8		-162986.879.87381.13
6163851.2
152268+14479*0.8		-163851.280.29681.51
20min1175845
161809+17545*0.8		-17584586.17487.471.8588.2289.581.83
2178904
164384+18150*0.8		-17890487.67389.77
3173598.8
159766+17291*0.8		-173598.885.07387.16
4179053.8
164729+17906*0.8		-179053.887.74689.93
5181149.8
166269+18601*0.8		-181149.888.77490.92
6182437.8
167769+18336*0.8		-182437.889.40591.51
30min1176462
153034+29285*0.8		-17646286.47690.762.5389.4893.842.49
2184012.6
159399+30767*0.8		-184012.690.17793.25
3187555
162403+31440*0.8		-18755591.91294.94
4189454.2
164519+31169*0.8		-189454.292.84396.00
5187879.2
162852+31284*0.8		-187879.292.07195.21
6185864.6
161463+30502*0.8		-185864.691.08494.18
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1184466
153702+38455*0.8		-18446690.39992.411.6794.3696.501.65
2190079
157643+40545*0.8		-19007993.14997.22
3189765.4
157671+40118*0.8		-189765.492.99697.05
4189219.4
157213+40008*0.8		-189219.492.72896.91
5192715.8
160043+40841*0.8		-192715.894.44298.60
6185204.8
154420+38481*0.8		-185204.890.76194.87
60min1179626.4
139556+50088*0.8		-179626.488.02791.101.8292.9996.221.80
2189877.8
147097+53476*0.8		-189877.893.05198.16
3186113.4
144451+52078*0.8		-186113.491.20696.29
4186703.2
144948+52194*0.8		-186703.291.49596.71
5186991.4
145245+52183*0.8		-186991.491.63696.84
6186114.2
145147+51209*0.8		-186114.291.20696.32
极限1181576
137204+55465*0.8		-18157688.98290.442.1394.9296.572.03
2185670.4
139452+57773*0.8		-185670.490.98997.13
3181445.2
136258+56484*0.8		-181445.288.91895.02
4180644.4
135650+56243*0.8		-180644.488.52694.76
5187904
141108+58495*0.8		-18790492.08498.31
6190117.4
143419+58373*0.8		-190117.493.16899.30
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%
119.23205851
205851+0		205765
205765+0		206046
206046+0		205399
205399+0		205325
205325+0		2056770.15
219.28207755
207755+0		207749
207749+0		2077520.01
单位质量响应值RSD%判断
10695.6310775.520.53数据可信
中间条件12月-供试品溶液-2023082621批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min187671.4
81289+7978*0.8		-87671.442.79442.452.4442.7942.452.43
288912.4
82978+7418*0.8		-88912.443.39943.40
383086
77406+7100*0.8		-8308640.55540.56
488457.2
82690+7209*0.8		-88457.243.17743.18
587472.2
81753+7149*0.8		-87472.242.69642.70
686236.2
79525+8389*0.8		-86236.242.09342.09
10min1135744.2
126117+12034*0.8		-135744.266.25967.552.4166.7368.022.39
2136658.4
127160+11873*0.8		-136658.466.70567.19
3138295.8
128519+12221*0.8		-138295.867.50467.95
4144113
134101+12515*0.8		-14411370.34470.82
5140170.2
130591+11974*0.8		-140170.268.41968.89
6135311.6
125898+11767*0.8		-135311.666.04866.52
15min1161387.2
149108+15349*0.8		-161387.278.77579.442.0879.9980.662.05
2159441.6
147180+15327*0.8		-159441.677.82679.05
3166540
153884+15820*0.8		-16654081.29182.49
4167420.6
154559+16077*0.8		-167420.681.72082.98
5160268.6
148007+15327*0.8		-160268.678.22979.46
6161436.4
149086+15438*0.8		-161436.478.79980.00
20min1178887.6
163598+19112*0.8		-178887.687.31886.542.2689.4088.642.21
2182035
166635+19250*0.8		-18203588.85490.94
3178152.8
162896+19071*0.8		-178152.886.95989.06
4179813.2
164554+19074*0.8		-179813.287.76989.94
5172244.2
157497+18434*0.8		-172244.284.07586.18
6172589.6
157784+18507*0.8		-172589.684.24486.32
30min1188903.2
163748+31444*0.8		-188903.292.20691.632.0995.2694.702.05
2189988.8
164968+31276*0.8		-189988.892.73695.81
3190251.2
164616+32044*0.8		-190251.292.86495.93
4190493
164713+32225*0.8		-19049392.98296.13
5180333
156241+30115*0.8		-18033388.02391.06
6186405
161725+30850*0.8		-18640590.98794.00
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1189287
157455+39790*0.8		-18928792.39493.401.7096.4897.481.65
2190461.6
158108+40442*0.8		-190461.692.96797.07
3196427.4
162805+42028*0.8		-196427.495.87999.98
4192159.2
159448+40889*0.8		-192159.293.79697.97
5186998.4
155248+39688*0.8		-186998.491.27795.29
6192724.6
160347+40472*0.8		-192724.694.07298.10
60min1182678.4
141452+51533*0.8		-182678.489.16889.431.2794.2894.561.24
2181068.2
140241+51034*0.8		-181068.288.38293.52
3186477
144033+53055*0.8		-18647791.02296.19
4184655.4
142577+52598*0.8		-184655.490.13395.35
5180328.8
139624+50881*0.8		-180328.888.02193.05
6184139.8
142943+51496*0.8		-184139.889.88194.95
极限1184430.2
138383+57559*0.8		-184430.290.02389.921.8096.1296.031.69
2182570.8
136910+57076*0.8		-182570.889.11595.24
3187773.8
140233+59426*0.8		-187773.891.65597.83
4181019.6
135462+56947*0.8		-181019.688.35894.58
5180959.6
136090+56087*0.8		-180959.688.32994.34
6188505.4
141695+58513*0.8		-188505.492.01298.08
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