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D69223050102 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%
119.75211202
211202+0
211315
211315+0
211264
211264+0
210941
210941+0
210981
210981+0
2111410.09
219.80214187
211115+3840*0.8
211247
211247+0
2127170.98
单位质量响应值RSD%判断
10690.6810743.280.35数据可信
制剂处方摸索--供试品溶液-23032401-1批-80mg规格-pH4.5(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min197075.8
95587+1861*0.8
-97075.847.46657.9713.7047.4757.9713.69
2132613.6
130672+2427*0.8
-132613.664.84264.84
3111133
109473+2075*0.8
-11113354.33954.34
4141915.4
139901+2518*0.8
-141915.469.39169.39
5111034.8
109358+2096*0.8
-111034.854.29154.29
6117554.8
115758+2246*0.8
-117554.857.47957.48
10min1161846.6
159577+2837*0.8
-161846.679.13684.594.4879.6685.244.54
2177229.2
174802+3034*0.8
-177229.286.65887.38
3166495
164211+2855*0.8
-16649581.40982.01
4183489
181037+3065*0.8
-18348989.71890.49
5174958
172534+3030*0.8
-17495885.54786.15
6174035.4
171629+3008*0.8
-174035.485.09685.73
15min1185214.2
182727+3109*0.8
-185214.290.56292.054.1091.9793.634.10
2185283.4
182785+3123*0.8
-185283.490.59692.28
3176976.4
174582+2993*0.8
-176976.486.53488.04
4197156
194556+3250*0.8
-19715696.40198.17
5196755.4
194113+3303*0.8
-196755.496.20597.76
6188112.4
185586+3158*0.8
-188112.491.97993.56
20min1192627
190067+3200*0.8
-19262794.18693.893.9096.6096.503.89
2188696.4
186178+3148*0.8
-188696.492.26594.95
3180096.6
177707+2987*0.8
-180096.688.06090.53
4201647.2
199044+3254*0.8
-201647.298.597101.44
5197723.2
195100+3279*0.8
-197723.296.67899.30
6191344.8
188788+3196*0.8
-191344.893.56096.17
30min1185791.2
183280+3139*0.8
-185791.290.84492.973.8094.3096.623.81
2185764.8
183232+3166*0.8
-185764.890.83194.55
3180462.6
178025+3047*0.8
-180462.688.23991.69
4199444.2
196821+3279*0.8
-199444.297.520101.45
5194893.2
192286+3259*0.8
-194893.295.29598.99
6194502.2
191879+3279*0.8
-194502.295.10398.75
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1189097.4
186515+3228*0.8
-189097.492.46193.003.2696.9397.683.28
2185040.2
182485+3194*0.8
-185040.290.47795.20
3181496.6
179011+3107*0.8
-181496.688.74493.17
4198041
195381+3325*0.8
-19804196.834101.85
5194472.4
191846+3283*0.8
-194472.495.08999.84
6193088.8
190452+3296*0.8
-193088.894.41299.11
60min1181716.4
179194+3153*0.8
-181716.488.85291.393.4794.3597.113.50
2183733.4
181135+3248*0.8
-183733.489.83895.57
3179345.6
176844+3127*0.8
-179345.687.69293.11
4196552.6
193859+3367*0.8
-196552.696.106102.20
5188940.4
186326+3268*0.8
-188940.492.38498.20
6191144.4
188514+3288*0.8
-191144.493.46299.21
极限1189532.2
186869+3329*0.8
-189532.292.67392.182.0299.1698.912.08
2184024.8
181416+3261*0.8
-184024.889.98096.71
3185611.4
182901+3388*0.8
-185611.490.75697.15
4194538.4
191856+3353*0.8
-194538.495.121102.28
5190464.8
187776+3361*0.8
-190464.893.12999.97
6186948.6
184315+3292*0.8
-186948.691.41098.20
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D69223050102 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%
119.75211293
211293+0
211153
211153+0
211461
211461+0
211415
211415+0
211549
211549+0
2113740.08
219.80210325.4
207287+3798*0.8
207794
207794+0
209059.70.86
单位质量响应值RSD%判断
10702.4810558.5710.96数据可信
制剂处方摸索--供试品溶液-2023082621批-80mg规格-pH4.5(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1129200.6
127727+1842*0.8
-129200.663.69059.764.3163.6959.764.31
2116715.2
115392+1654*0.8
-116715.257.53557.54
3119612.8
118224+1736*0.8
-119612.858.96458.96
4115125.8
113825+1626*0.8
-115125.856.75256.75
5124635.6
123182+1817*0.8
-124635.661.44061.44
6122113.2
120746+1709*0.8
-122113.260.19660.20
10min1178607.4
176697+2388*0.8
-178607.488.04586.861.7888.7587.531.79
2171896
170036+2325*0.8
-17189684.73785.38
3179371.4
177421+2438*0.8
-179371.488.42289.08
4174633
172765+2335*0.8
-17463386.08686.72
5178835.8
176851+2481*0.8
-178835.888.15888.84
6173915
172075+2300*0.8
-17391585.73286.40
15min1188868
186868+2500*0.8
-18886893.10392.410.6994.7994.040.68
2186771
184759+2515*0.8
-18677192.07093.65
3186072.8
184020+2566*0.8
-186072.891.72593.36
4189108.4
187110+2498*0.8
-189108.493.22294.81
5186427.8
184415+2516*0.8
-186427.891.90093.56
6187475
185535+2425*0.8
-18747592.41794.04
20min1187069.2
185070+2499*0.8
-187069.292.21691.980.8994.9494.640.86
2186043.6
184030+2517*0.8
-186043.691.71194.31
3188303.2
186256+2559*0.8
-188303.292.82595.48
4188533.4
186531+2503*0.8
-188533.492.93895.56
5184640
182640+2500*0.8
-18464091.01993.70
6184983
183063+2400*0.8
-18498391.18893.84
30min1182400.8
180432+2461*0.8
-182400.889.91590.460.9393.6694.140.88
2184567.4
182545+2528*0.8
-184567.490.98394.61
3183655
181595+2575*0.8
-18365590.53394.22
4185990.2
183983+2509*0.8
-185990.291.68595.34
5183365.8
181329+2546*0.8
-183365.890.39194.09
6181095.8
179167+2411*0.8
-181095.889.27292.93
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1186199.6
184150+2562*0.8
-186199.691.78889.791.7796.5394.471.71
2180837.2
178806+2539*0.8
-180837.289.14493.78
3180256.6
178223+2542*0.8
-180256.688.85893.55
4185392.8
183328+2581*0.8
-185392.891.39096.06
5182462
180422+2550*0.8
-18246289.94594.64
6177719.2
175780+2424*0.8
-177719.287.60792.26
60min1176031.2
174056+2469*0.8
-176031.286.77587.631.1692.5493.311.09
2175284.2
173265+2524*0.8
-175284.286.40792.03
3177997.2
175922+2594*0.8
-177997.287.74493.43
4180855.6
178826+2537*0.8
-180855.689.15394.84
5177150.4
175080+2588*0.8
-177150.487.32793.03
6179217.2
177242+2469*0.8
-179217.288.34693.97
极限1179334.8
177254+2601*0.8
-179334.888.40488.161.0195.1394.820.95
2177857.8
175769+2611*0.8
-177857.887.67694.26
3175710.4
173640+2588*0.8
-175710.486.61793.27
4180554.2
178475+2599*0.8
-180554.289.00595.69
5179467.8
177299+2711*0.8
-179467.888.46995.14
6180160.8
178108+2566*0.8
-180160.888.81195.42
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D69223050102 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%
119.75211020
211020+0
210814
210814+0
210680
210680+0
210474
210474+0
210116
210116+0
2106210.17
219.80209492
209492+0
209370
209370+0
2094310.05
单位质量响应值RSD%判断
10664.3510577.320.58数据可信
制剂处方摸索--供试品溶液-12343797批-80mg规格-pH4.5(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182457.4
81083+1718*0.8
-82457.440.68452.4523.1140.6852.4523.12
2141596.2
140013+1979*0.8
-141596.269.86269.86
3129714.2
128127+1984*0.8
-129714.264.00064.00
491933
90817+1395*0.8
-9193345.35945.36
5107016.4
105462+1943*0.8
-107016.452.80152.80
685135.6
84022+1392*0.8
-85135.642.00542.00
10min1164917.2
163018+2374*0.8
-164917.281.36887.567.5881.8288.157.68
2195572.2
193549+2529*0.8
-195572.296.49397.27
3189200.8
187080+2651*0.8
-189200.893.35094.06
4174771.8
172883+2361*0.8
-174771.886.23186.73
5179354
176970+2980*0.8
-17935488.49189.08
6161034.6
159149+2357*0.8
-161034.679.45379.92
15min1184024.2
181957+2584*0.8
-184024.290.79695.874.8192.1597.424.93
2208744.6
206447+2872*0.8
-208744.6102.992104.84
3198897
196689+2760*0.8
-19889798.13499.88
4196453.6
194352+2627*0.8
-196453.696.92898.39
5193135.2
190600+3169*0.8
-193135.295.29196.86
6184576.4
182442+2668*0.8
-184576.491.06892.42
20min1194255.2
192072+2729*0.8
-194255.295.84397.391.3798.21100.011.57
2201429.2
199350+2599*0.8
-201429.299.383102.38
3198543
196359+2730*0.8
-19854397.959100.80
4198805
196685+2650*0.8
-19880598.088100.63
5196254.8
193702+3191*0.8
-196254.896.83099.46
6195005.4
192731+2843*0.8
-195005.496.21498.57
30min1189350
187186+2705*0.8
-18935093.42396.921.9496.85100.622.06
2199085.2
196970+2644*0.8
-199085.298.226102.32
3197341.6
195112+2787*0.8
-197341.697.366101.29
4197437.4
195291+2683*0.8
-197437.497.413101.04
5199956.4
197310+3308*0.8
-199956.498.656102.36
6195459.8
193175+2856*0.8
-195459.896.43899.87
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1195578.8
193326+2816*0.8
-195578.896.49697.121.27100.96101.901.37
2199178
197030+2685*0.8
-19917898.272103.46
3195524.8
193256+2836*0.8
-195524.896.470101.48
4200239.4
198005+2793*0.8
-200239.498.796103.51
5196951.6
194302+3312*0.8
-196951.697.174101.97
6193595.4
191293+2878*0.8
-193595.495.518100.02
60min1192453.8
190185+2836*0.8
-192453.894.95596.231.26100.49102.091.23
2193767
191619+2685*0.8
-19376795.603101.88
3194382.8
192102+2851*0.8
-194382.895.906101.99
4194853.2
192662+2739*0.8
-194853.296.138101.95
5199620.8
196904+3396*0.8
-199620.898.491104.37
6195200
192852+2935*0.8
-19520096.310101.87
极限1190686.4
188408+2848*0.8
-190686.494.08394.630.93100.68101.560.85
2190812.6
188691+2652*0.8
-190812.694.145101.49
3190316.6
188039+2847*0.8
-190316.693.900101.05
4195179.2
192952+2784*0.8
-195179.296.299103.18
5191741.8
189113+3286*0.8
-191741.894.603101.58
6192040.2
189713+2909*0.8
-192040.294.751101.38
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