富马酸伏诺拉生片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.052462342444522449842452002445422450820.30
215.162451362461232456300.29
单位质量响应值RSD%判断
16284.5216202.510.36数据可信
中间条件12月-供试品溶液-2023030911批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1198009-19800981.93875.5010.3981.9475.5010.39
2202583-20258383.83183.83
3156680-15668064.83664.84
4170935-17093570.73570.73
5170031-17003170.36070.36
6196513-19651381.31981.32
10min1239486-23948699.10295.473.1799.2495.593.18
2235206-23520697.33197.47
3219567-21956790.85990.97
4226404-22640493.68893.81
5228290-22829094.46994.59
6235243-23524397.34697.48
15min1244241-244241101.06999.261.47101.3799.551.48
2239270-23927099.01299.31
3234465-23446597.02497.28
4242448-242448100.327100.60
5237673-23767398.35198.63
6241177-24117799.801100.10
20min1246882-246882102.162100.291.58102.63100.741.58
2240750-24075099.625100.09
3238201-23820198.57098.99
4247230-247230102.306102.75
5239600-23960099.14999.59
6241496-24149699.933100.40
30min1246748-246748102.107100.431.34102.75101.051.33
2239707-23970799.19399.83
3239824-23982499.24199.83
4246715-246715102.093102.70
5241392-24139299.890100.49
6241820-241820100.067100.70
45min1247505-247505102.420100.741.44103.23101.531.44
2240356-24035699.462100.26
3240559-24055999.546100.30
4248043-248043102.643103.42
5241149-24114999.790100.56
6243094-243094100.595101.39
60min1246405-246405101.965100.591.14102.95101.541.14
2240425-24042599.490100.45
3241631-24163199.989100.91
4246806-246806102.131103.08
5241626-24162699.987100.92
6241654-24165499.999100.96
极限1246924-246924102.180100.561.20103.33101.681.19
2239809-23980999.235100.37
3241644-24164499.995101.08
4246186-246186101.874103.00
5241001-24100199.729100.83
6242475-242475100.338101.47
富马酸伏诺拉生片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.052452072456742460042455322462652457360.17
215.162454212457322455760.09
单位质量响应值RSD%判断
16327.9716198.940.57数据可信
中间条件12月-供试品溶液-2023031111批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1198467-19846782.02879.516.1982.0379.516.19
2192945-19294579.74579.75
3209481-20948186.58086.58
4175853-17585372.68172.68
5194955-19495580.57680.58
6182497-18249775.42775.43
10min1240076-24007699.22596.383.2399.3696.513.24
2233380-23338096.45796.59
3241260-24126099.71499.86
4226823-22682393.74793.87
5235551-23555197.35597.49
6222022-22202291.76391.89
15min1244914-244914101.22499.571.35101.5399.861.36
2240206-24020699.27999.57
3242067-242067100.048100.36
4239205-23920598.86599.14
5243315-243315100.564100.86
6235779-23577997.44997.73
20min1245806-245806101.593100.560.65102.06101.020.66
2242428-242428100.197100.66
3244088-244088100.883101.36
4242860-242860100.375100.82
5243516-243516100.647101.11
6241173-24117399.678100.12
30min1247719-247719102.384101.120.67103.02101.750.68
2244286-244286100.965101.59
3244034-244034100.861101.51
4243088-243088100.470101.08
5245148-245148101.321101.95
6243751-243751100.744101.35
45min1246953-246953102.067101.290.78102.88102.090.78
2247465-247465102.279103.07
3243416-243416100.605101.42
4242613-242613100.273101.05
5244694-244694101.134101.93
6245329-245329101.396102.17
60min1246025-246025101.684101.330.69102.66102.300.68
2246650-246650101.942102.91
3242838-242838100.366101.35
4243335-243335100.572101.52
5245451-245451101.446102.42
6246727-246727101.974102.92
极限1245594-245594101.505101.161.08102.66102.291.07
2247203-247203102.170103.31
3241529-24152999.825100.97
4241948-24194899.999101.11
5244397-244397101.011102.15
6247818-247818102.425103.54
富马酸伏诺拉生片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.052467842467352465612461382465382465510.11
215.162461862457512459680.13
单位质量响应值RSD%判断
16382.1316224.800.69数据可信
长期12月-供试品溶液-2023030911批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1182857-18285775.39178.508.2475.3978.508.24
2196828-19682881.15181.15
3195106-19510680.44180.44
4178602-17860273.63773.64
5216137-21613789.11289.11
6172867-17286771.27271.27
10min1231283-23128395.35794.973.6695.4895.103.66
2229640-22964094.67994.81
3237184-23718497.79097.92
4224314-22431492.48492.61
5241418-24141899.53599.68
6218200-21820089.96390.08
15min1237955-23795598.10898.251.5498.3998.541.55
2236495-23649597.50697.80
3243387-243387100.347100.64
4235540-23554097.11297.39
5242070-24207099.804100.12
6234314-23431496.60696.88
20min1238405-23840598.29399.170.9298.7499.620.93
2238755-23875598.43798.89
3243820-243820100.526100.99
4238800-23880098.45698.89
5242046-24204699.794100.28
6241341-24134199.50499.93
30min1238408-23840898.29499.740.9998.91100.360.98
2240466-24046699.14399.76
3244104-244104100.643101.27
4240883-24088399.31599.92
5243213-243213100.275100.92
6244427-244427100.776101.37
45min1238802-23880298.457100.191.1399.23100.971.13
2241562-24156299.595100.38
3244965-244965100.998101.80
4242361-24236199.924100.69
5243633-243633100.449101.26
6246641-246641101.689102.45
60min1238808-23880898.459100.381.2199.40101.331.20
2241891-24189199.730100.68
3244880-244880100.963101.93
4243443-243443100.370101.31
5244291-244291100.720101.70
6247469-247469102.030102.96
极限1239445-23944598.722100.711.2099.83101.831.19
2243727-243727100.487101.60
3245484-245484101.212102.35
4244176-244176100.673101.77
5244250-244250100.703101.85
6248493-248493102.452103.56
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