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101242-201201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(%)100.0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%
1 16.451971171972011972541973441973611972550.06
2 16.521966591972371969480.21
单位质量响应值RSD%判断
11991.1911921.790.42数据可信
供试品溶液-3E99SDC1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%
5min117658-176588.8619.565.958.869.565.95
218963-189639.5169.52
318814-188149.4419.44
421046-2104610.56110.56
519366-193669.7189.72
618480-184809.2749.27
10min137081-3708118.60818.691.3518.6218.711.36
238003-3800319.07119.09
337309-3730918.72318.74
437415-3741518.77618.79
537212-3721218.67418.69
636458-3645818.29518.31
15min154712-5471227.45627.400.9427.5027.450.94
254612-5461227.40627.45
354771-5477127.48527.53
455281-5528127.74127.79
553714-5371426.95527.00
654550-5455027.37427.42
20min169597-6959734.92534.660.8435.0234.760.85
269578-6957834.91635.01
369177-6917734.71534.81
469348-6934834.80034.90
568215-6821534.23234.32
668512-6851234.38134.47
30min194846-9484647.59646.351.3847.7546.501.38
291596-9159645.96546.12
392157-9215746.24746.40
492012-9201246.17446.33
591291-9129145.81245.96
692287-9228746.31246.46
45min1118681-11868159.55759.230.5659.7959.460.57
2117202-11720258.81559.04
3117541-11754158.98559.21
4118347-11834759.38959.62
5117624-11762459.02759.25
6118780-11878059.60759.83
60min1142433-14243371.47668.891.9971.8069.221.98
2136214-13621468.35568.68
3136354-13635468.42668.75
4136892-13689268.69669.02
5134401-13440167.44667.77
6137438-13743868.97069.30
90min1163000-16300081.79780.700.8282.2481.140.82
2160401-16040180.49380.93
3159721-15972180.15280.59
4161071-16107180.82981.27
5159364-15936479.97380.41
6161310-16131080.94981.39
120min1177383-17738389.01588.311.1189.6088.881.10
2175316-17531687.97888.55
3172765-17276586.69887.27
4175517-17551788.07988.66
5178358-17835889.50490.07
6176472-17647288.55889.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1193021-19302196.86395.530.8797.5996.250.87
2190190-19019095.44296.16
3188178-18817894.43295.15
4190947-19094795.82296.55
5190623-19062395.65996.38
6189204-18920494.94795.67
240min1197657-19765799.18997.821.26100.0898.701.25
2196338-19633898.52799.41
3190544-19054495.62096.50
4195383-19538398.04898.93
5194124-19412497.41698.29
6195547-19554798.13099.01
极限1199582-199582100.15598.511.24101.2199.561.23
2194855-19485597.78398.83
3192714-19271496.70897.74
4197582-19758299.151100.20
5195569-19556998.14199.18
6197536-19753699.128100.17
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101242-201201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(%)100.0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%
1 16.451998651974791980261983841984661984440.45
2 16.521986991987291987140.02
单位质量响应值RSD%判断
12063.4712028.690.21数据可信
供试品溶液-3E99SDC1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%
5min116476-164768.2078.484.558.218.494.56
217235-172358.5858.58
316374-163748.1568.16
417839-178398.8858.89
516265-162658.1018.10
618020-180208.9768.98
10min144538-4453822.18418.859.9322.2018.869.93
238475-3847519.16419.18
336950-3695018.40418.42
437235-3723518.54618.56
533027-3302716.45016.46
636857-3685718.35818.37
15min157581-5758128.68028.404.3428.7328.444.33
259463-5946329.61829.66
357515-5751528.64828.69
457873-5787328.82628.87
552216-5221626.00826.05
657416-5741628.59828.64
20min175364-7536437.53837.014.5437.6437.114.54
276883-7688338.29538.39
376072-7607237.89137.98
474915-7491537.31437.41
567598-6759833.67033.75
675047-7504737.38037.47
30min1100076-10007649.84750.626.3150.0150.776.30
2102993-10299351.30051.46
3101934-10193450.77250.93
4101218-10121850.41650.57
591743-9174345.69645.84
6111780-11178055.67655.83
45min1127126-12712663.32064.135.1863.5664.375.17
2138869-13886969.16969.41
3129099-12909964.30364.54
4129988-12998864.74664.99
5118036-11803658.79259.01
6129410-12941064.45864.71
60min1146991-14699173.21573.293.8973.5673.633.89
2148118-14811873.77674.14
3154515-15451576.96277.31
4147967-14796773.70174.05
5136836-13683668.15668.47
6148387-14838773.91074.27
90min1169798-16979884.57484.813.0685.0585.283.06
2169717-16971784.53485.02
3175795-17579587.56188.04
4171809-17180985.57686.05
5160791-16079180.08880.52
6173751-17375186.54387.02
120min1181899-18189990.60290.692.5791.2191.302.58
2182176-18217690.74091.36
3184801-18480192.04792.67
4184552-18455291.92392.54
5173085-17308586.21286.77
6185900-18590092.59593.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1193440-19344096.35095.931.9497.1196.691.95
2191532-19153295.40096.18
3195305-19530597.27998.05
4192698-19269895.98196.75
5185938-18593892.61493.32
6196622-19662297.93598.71
240min1195046-19504697.15097.711.8598.0798.621.86
2195604-19560497.42898.36
3198493-19849398.86799.80
4197004-19700498.12599.05
5190096-19009694.68595.54
6200745-20074599.989100.93
极限1197706-19770698.47598.161.6899.5699.241.69
2195058-19505897.15698.25
3198896-19889699.068100.17
4200548-20054899.891100.98
5191452-19145295.36096.38
6198810-19881099.025100.13
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101242-201201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(%)100.0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%
1 16.451967571965631971391972171970541969460.15
2 16.521989431985661987540.14
单位质量响应值RSD%判断
11972.4012031.110.35数据可信
供试品溶液-3E99SDC1批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123461-2346111.72911.622.0811.7311.622.09
223062-2306211.52911.53
323905-2390511.95111.95
422587-2258711.29211.29
523575-2357511.78611.79
622925-2292511.46111.46
10min150847-5084725.42025.052.1025.4425.062.10
250655-5065525.32425.34
351043-5104325.51825.54
450392-5039225.19225.21
549309-4930924.65124.67
648352-4835224.17324.19
15min171717-7171735.85335.631.8235.9235.691.82
271210-7121035.60035.66
371537-7153735.76335.83
472360-7236036.17536.24
572013-7201336.00136.06
668754-6875434.37234.43
20min188712-8871244.35043.861.9044.4743.981.90
288020-8802044.00444.12
385823-8582342.90543.03
489807-8980744.89745.02
588406-8840644.19744.32
685635-8563542.81142.93
30min1111978-11197855.98155.691.1356.1855.881.13
2111312-11131255.64855.84
3111831-11183155.90856.10
4112922-11292256.45356.65
5111169-11116955.57755.77
6109184-10918454.58454.77
45min1136817-13681768.39968.181.0868.6968.471.07
2134839-13483967.41067.70
3137821-13782168.90169.19
4137113-13711368.54768.84
5137433-13743368.70768.99
6134291-13429167.13667.42
60min1155231-15523177.60576.860.8778.0177.260.87
2153284-15328476.63177.03
3154100-15410077.03977.44
4153764-15376476.87177.28
5154623-15462377.30177.70
6151398-15139875.68876.08
90min1175761-17576187.86887.021.0988.4087.551.09
2172271-17227186.12386.65
3174541-17454187.25887.79
4174621-17462187.29887.83
5175921-17592187.94888.48
6171296-17129685.63686.15
120min1187144-18714493.55992.481.0794.2493.151.07
2184082-18408292.02892.70
3185744-18574492.85993.53
4183846-18384691.91092.59
5186953-18695393.46394.14
6182099-18209991.03791.70
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1196144-19614498.05897.260.9998.8998.080.99
2192088-19208896.03196.85
3194774-19477497.37398.20
4194545-19454597.25998.09
5197041-19704198.50799.34
6192654-19265496.31397.12
240min1198523-19852399.24898.700.47100.2599.690.48
2196742-19674298.35799.34
3197345-19734598.65999.65
4197430-19743098.70199.69
5198368-19836899.170100.17
6196130-19613098.05199.02
极限1199713-19971399.84299.140.65101.01100.300.66
2197433-19743398.70399.85
3198307-19830799.140100.30
4197916-19791698.944100.10
5199908-19990899.940101.10
6196625-19662598.29999.43
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