托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.483908293841433816563835013825103845280.95
216.553914753925693920220.20
单位质量响应值RSD%判断
23333.0123687.131.07数据可信
供试品溶液-2025050421批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138015-380159.6939.522.629.699.522.60
236815-368159.3879.39
335640-356409.0879.09
437485-374859.5589.56
537957-379579.6789.68
638198-381989.7399.74
10min173892-7389218.84018.631.5218.8618.651.52
272878-7287818.58218.60
370981-7098118.09818.11
473991-7399118.86518.88
573416-7341618.71918.73
673310-7331018.69218.71
15min1102575-10257526.15326.211.3726.2026.251.37
2102127-10212726.03926.09
3100754-10075425.68925.73
4103592-10359226.41326.46
5102738-10273826.19526.24
6104919-10491926.75126.80
20min1125376-12537631.96732.110.7532.0632.200.75
2125740-12574032.06032.15
3124398-12439831.71831.81
4126629-12662932.28632.38
5126549-12654932.26632.36
6126865-12686532.34732.44
30min1161458-16145841.16741.251.2941.3141.391.29
2160592-16059240.94641.09
3159983-15998340.79140.93
4160724-16072440.98041.12
5162180-16218041.35141.50
6165736-16573642.25842.40
45min1198971-19897150.73151.210.7450.9451.420.74
2202076-20207651.52351.73
3199446-19944650.85351.06
4200455-20045551.11051.32
5202671-20267151.67551.89
6201494-20149451.37551.59
60min1228202-22820258.18457.950.4558.4858.240.45
2225883-22588357.59357.89
3226138-22613857.65857.95
4227526-22752658.01258.31
5228115-22811558.16258.46
6227771-22777158.07558.38
90min1261461-26146166.66466.940.8467.0667.330.84
2262093-26209366.82667.22
3260583-26058366.44166.83
4265135-26513567.60168.00
5260539-26053966.42966.83
6265357-26535767.65868.06
120min1287618-28761873.33473.370.5873.8473.880.57
2285619-28561972.82473.33
3286940-28694073.16173.66
4287633-28763373.33873.85
5288140-28814073.46773.97
6290595-29059574.09374.60
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1301765-30176576.94176.630.6577.5777.260.64
2298623-29862376.14076.77
3300083-30008376.51277.13
4303794-30379477.45878.09
5298963-29896376.22676.86
6300005-30000576.49277.13
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.483966163961523962853965033960893963290.06
216.553908663951233929940.77
单位质量响应值RSD%判断
24049.0923745.860.90数据可信
供试品溶液-2025050421批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139767-397679.9759.463.129.979.463.09
237822-378229.4879.49
337080-370809.3019.30
437909-379099.5099.51
536265-362659.0969.10
637373-373739.3749.37
10min174843-7484318.77318.311.5418.7918.321.54
272361-7236118.15018.17
371607-7160717.96117.98
472776-7277618.25518.27
572673-7267318.22918.24
673616-7361618.46518.48
15min1103830-10383026.04425.591.2326.0925.641.23
2101910-10191025.56225.61
399916-9991625.06225.11
4102051-10205125.59825.64
5102294-10229425.65925.70
6102219-10221925.64025.69
20min1126921-12692131.83631.640.7231.9331.730.73
2124793-12479331.30231.39
3127372-12737231.94932.04
4126145-12614531.64131.73
5125831-12583131.56231.65
6125863-12586331.57031.66
30min1165958-16595841.62840.661.2441.7740.801.24
2160869-16086940.35140.49
3161527-16152740.51640.66
4160374-16037440.22740.37
5161534-16153440.51840.66
6162317-16231740.71440.86
45min1200809-20080950.36950.390.7650.5850.600.76
2199788-19978850.11350.32
3198764-19876449.85650.06
4200899-20089950.39250.60
5202366-20236650.76050.97
6202814-20281450.87251.08
60min1229067-22906757.45757.410.6457.7557.700.64
2228657-22865757.35457.65
3229187-22918757.48757.78
4231135-23113557.97658.27
5226570-22657056.83157.12
6228605-22860557.34157.64
90min1264921-26492166.45166.540.2466.8466.930.24
2265591-26559166.61967.01
3264986-26498666.46766.85
4266128-26612866.75367.14
5264381-26438166.31566.70
6265648-26564866.63367.02
120min1291604-29160473.14372.250.6973.6572.750.69
2288759-28875972.43072.93
3286024-28602471.74472.24
4286867-28686771.95572.46
5287347-28734772.07672.57
6287702-28770272.16572.67
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1307118-30711877.03575.720.9877.6676.340.98
2302753-30275375.94076.56
3299367-29936775.09175.71
4298923-29892374.97975.60
5301185-30118575.54776.17
6301962-30196275.74276.36
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.483956363955123959733956843955713956750.05
216.553992544001743997140.17
单位质量响应值RSD%判断
24009.4124151.900.42数据可信
供试品溶液-2025050621批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137503-375039.33510.0510.099.3410.0510.10
238024-380249.4659.46
335372-353728.8058.80
441345-4134510.29110.29
545141-4514111.23611.24
644893-4489311.17511.17
10min172176-7217617.96618.304.3017.9818.324.29
271955-7195517.91117.93
370710-7071017.60117.62
471268-7126817.74017.76
576627-7662719.07419.09
678313-7831319.49319.51
15min1101129-10112925.17325.552.7125.2225.602.72
2102646-10264625.55025.60
3100509-10050925.01825.06
499766-9976624.83324.88
5104851-10485126.09926.15
6106963-10696326.62526.68
20min1126709-12670931.54031.611.7731.6331.701.78
2127022-12702231.61831.71
3124883-12488331.08531.17
4124370-12437030.95831.05
5128443-12844331.97132.07
6130405-13040532.46032.56
30min1162222-16222240.38040.611.4940.5240.761.50
2164328-16432840.90441.04
3162027-16202740.33140.47
4159385-15938539.67339.81
5164952-16495241.05941.21
6166077-16607741.33941.49
45min1201077-20107750.05150.241.2750.2650.461.27
2205279-20527951.09751.31
3201003-20100350.03350.24
4197744-19774449.22249.43
5202739-20273950.46550.68
6203282-20328250.60050.82
60min1227072-22707256.52256.612.0256.8156.902.02
2229753-22975357.18957.48
3228517-22851756.88157.17
4218453-21845354.37654.66
5230675-23067557.41957.72
6230149-23014957.28857.59
90min1266788-26678866.40865.810.9366.7966.200.93
2264154-26415465.75266.14
3264240-26424065.77366.16
4259859-25985964.68365.06
5265443-26544366.07366.47
6265930-26593066.19466.59
120min1288807-28880771.88971.931.1172.3872.421.12
2290974-29097472.42872.93
3287978-28797871.68272.17
4283522-28352270.57371.06
5289443-28944372.04772.55
6293022-29302272.93873.45
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1302535-30253575.30675.311.0875.9275.921.08
2304894-30489475.89376.51
3301197-30119774.97375.58
4296774-29677473.87274.48
5305754-30575476.10776.73
6304064-30406475.68676.32
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