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%
119.23203779
203779+0
203857
203857+0
203927
203927+0
203934
203934+0
203923
203923+0
2038840.04
219.28204747
204747+0
204874
204874+0
2048100.05
单位质量响应值RSD%判断
10602.3910622.930.14数据可信
长期12月-供试品溶液-2023082221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%
5min196459.6
88338+10152*0.8
-96459.647.62850.045.1747.6350.045.17
2103199.4
96241+8698*0.8
-103199.450.95650.96
399875.2
92972+8629*0.8
-99875.249.31549.31
4103521.4
96435+8858*0.8
-103521.451.11551.11
595419
87143+10345*0.8
-9541947.11447.11
6109561.6
100992+10712*0.8
-109561.654.09754.10
10min1147338.4
136816+13153*0.8
-147338.472.75074.822.2273.2875.382.21
2147741.2
137090+13314*0.8
-147741.272.94973.52
3151663
140695+13710*0.8
-15166374.88575.43
4154651.8
143363+14111*0.8
-154651.876.36176.93
5155184.4
142994+15238*0.8
-155184.476.62477.15
6152661.2
141258+14254*0.8
-152661.275.37875.98
15min1171558
157914+17055*0.8
-17155884.70985.901.9086.0587.281.88
2169370.4
155772+16998*0.8
-169370.483.62985.01
3176049
161797+17815*0.8
-17604986.92688.31
4172847.6
158834+17517*0.8
-172847.685.34686.76
5178336.2
162605+19664*0.8
-178336.288.05689.43
6175602.2
160751+18564*0.8
-175602.286.70688.14
20min1182985.2
166910+20094*0.8
-182985.290.35189.740.7192.6392.080.68
2180113.2
164042+20089*0.8
-180113.288.93391.24
3183358.4
166888+20588*0.8
-183358.490.53592.88
4181563
165247+20395*0.8
-18156389.64992.01
5181909
163977+22415*0.8
-18190989.82092.17
6180538.8
163430+21386*0.8
-180538.889.14391.55
30min1186375.6
160150+32782*0.8
-186375.692.02590.611.1695.3193.951.08
2184999.2
158544+33069*0.8
-184999.291.34694.64
3180376.8
154512+32331*0.8
-180376.889.06392.41
4184008
157404+33255*0.8
-18400890.85694.22
5183075.6
155906+33962*0.8
-183075.690.39693.75
6182220.8
154312+34886*0.8
-182220.889.97493.37
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1184839.2
151964+41094*0.8
-184839.291.26790.210.8995.5794.560.84
2182397.2
149442+41194*0.8
-182397.290.06194.37
3180683.8
147983+40876*0.8
-180683.889.21593.56
4184343
150775+41960*0.8
-18434391.02295.39
5181424
145444+44975*0.8
-18142489.58093.94
6182520.4
147354+43958*0.8
-182520.490.12294.51
60min1182933.8
143709+49031*0.8
-182933.890.32689.191.6595.6494.541.57
2176484.2
138433+47564*0.8
-176484.287.14192.45
3181824.4
142618+49008*0.8
-181824.489.77895.11
4178139
139779+47950*0.8
-17813987.95893.34
5180139.6
137842+52872*0.8
-180139.688.94694.30
6184338.4
142532+52258*0.8
-184338.491.01996.41
极限1180447.4
136621+54783*0.8
-180447.489.09888.981.0895.4295.321.05
2177622
134782+53550*0.8
-17762287.70393.98
3180185.2
136734+54314*0.8
-180185.288.96995.30
4181458.6
137505+54942*0.8
-181458.689.59795.96
5178499
131035+59330*0.8
-17849988.13694.48
6182980.4
136638+57928*0.8
-182980.490.34996.75
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