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%
116.553964763969283966053963293967663966210.06
216.453972073974943973500.06
单位质量响应值RSD%判断
23965.0224155.020.56数据可信
供试品溶液-2K72SDB2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%
5min126537-265376.6186.493.696.626.483.71
227588-275886.8806.88
325512-255126.3626.36
425224-252246.2906.29
525042-250426.2456.24
626136-261366.5186.52
10min173350-7335018.29218.131.8718.3018.141.88
273808-7380818.40618.42
373034-7303418.21318.22
473868-7386818.42118.43
571740-7174017.89117.90
670424-7042417.56217.57
15min1103305-10330525.76225.711.3225.8025.761.33
2104692-10469226.10826.15
3104577-10457726.07926.12
4101214-10121425.24125.28
5102214-10221425.49025.53
6102687-10268725.60825.65
20min1128831-12883132.12831.741.1532.2131.821.15
2129099-12909932.19532.28
3127556-12755631.81031.89
4125941-12594131.40731.49
5125830-12583031.38031.46
6126283-12628331.49231.58
30min1165844-16584441.35841.030.8841.5041.170.88
2165396-16539641.24741.39
3166112-16611241.42541.56
4162614-16261440.55340.69
5163697-16369740.82340.96
6163490-16349040.77140.91
45min1206455-20645551.48651.320.7151.6951.530.71
2206867-20686751.58951.80
3207539-20753951.75651.96
4203832-20383250.83251.03
5204369-20436950.96651.17
6205760-20576051.31251.52
60min1238725-23872559.53359.360.6259.8359.650.61
2238711-23871159.53059.82
3240041-24004159.86160.15
4235859-23585958.81959.11
5237686-23768659.27459.56
6237137-23713759.13759.43
90min1277317-27731769.15769.530.8969.5569.920.88
2281050-28105070.08870.48
3280606-28060669.97870.37
4274600-27460068.48068.87
5279232-27923269.63570.02
6280129-28012969.85970.25
120min1306108-30610876.33776.600.2676.8477.110.26
2307907-30790776.78677.30
3307845-30784576.77077.28
4306870-30687076.52777.03
5307819-30781976.76477.27
6306525-30652576.44176.95
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1317458-31745879.16879.300.9679.8079.930.96
2319874-31987479.77080.41
3319989-31998979.79980.44
4312818-31281878.01178.64
5316591-31659178.95279.58
6321129-32112980.08380.71
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%
116.553958653957943960913957773956053958260.05
216.453967103964673965880.05
单位质量响应值RSD%判断
23916.9824108.690.57数据可信
供试品溶液-2K72SDB2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%
5min123883-238835.9686.034.145.976.044.14
224283-242836.0686.07
325696-256966.4216.42
424756-247566.1866.19
523276-232765.8165.82
622985-229855.7435.74
10min170708-7070817.66817.892.1017.6817.902.11
270847-7084717.70317.71
372351-7235118.07818.09
474141-7414118.52618.54
571668-7166817.90817.92
669911-6991117.46917.48
15min1103482-10348225.85725.800.9825.9025.840.98
2103425-10342525.84325.88
3103985-10398525.98326.02
4104446-10444626.09826.14
5102677-10267725.65625.70
6101622-10162225.39225.43
20min1126410-12641031.58631.820.5431.6731.910.54
2126928-12692831.71631.80
3127684-12768431.90431.99
4128379-12837932.07832.16
5127600-12760031.88331.97
6127172-12717231.77731.86
30min1164938-16493841.21341.230.7741.3541.370.77
2164007-16400740.98041.12
3165611-16561141.38141.52
4166628-16662841.63541.77
5165717-16571741.40841.54
6163134-16313440.76240.90
45min1208787-20878752.17051.700.7352.3751.900.73
2205454-20545451.33751.54
3207649-20764951.88552.09
4208195-20819552.02252.23
5205997-20599751.47351.68
6205271-20527151.29151.49
60min1236940-23694059.20459.520.4459.5059.810.44
2237247-23724759.28159.57
3238433-23843359.57759.87
4239873-23987359.93760.23
5238210-23821059.52259.81
6238400-23840059.56959.86
90min1282483-28248370.58469.910.5470.9770.300.53
2278454-27845469.57769.97
3279036-27903669.72370.11
4280491-28049170.08670.48
5278995-27899569.71370.10
6279266-27926669.78070.17
120min1311059-31105977.72477.260.6578.2377.770.64
2306960-30696076.70077.20
3312140-31214077.99578.50
4307995-30799576.95977.47
5309010-30901077.21277.72
6308139-30813976.99577.50
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1322761-32276180.64879.870.6481.2980.510.64
2316790-31679079.15679.79
3319573-31957379.85280.49
4319837-31983779.91880.56
5320716-32071680.13780.77
6318303-31830379.53480.17
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%
116.553999263995034000133998534000593998710.06
216.454023104032514027800.17
单位质量响应值RSD%判断
24161.3924485.110.95数据可信
供试品溶液-2025030721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%
5min129250-292507.2167.643.457.227.643.43
230170-301707.4437.44
331370-313707.7397.74
431159-311597.6877.69
532163-321637.9347.93
631658-316587.8107.81
10min160042-6004214.81215.603.4514.8215.613.46
262274-6227415.36215.37
363767-6376715.73115.74
462254-6225415.35715.37
566271-6627116.34816.36
664708-6470815.96315.98
15min184107-8410720.74821.783.3520.7821.823.35
286104-8610421.24121.28
387926-8792621.69021.73
488552-8855221.84521.88
591831-9183122.65422.69
691213-9121322.50122.54
20min1103822-10382225.61226.562.6025.6826.632.61
2106057-10605726.16326.24
3107828-10782826.60026.68
4107633-10763326.55226.63
5112291-11229127.70127.78
6108281-10828126.71226.79
30min1133794-13379433.00533.912.6333.1234.032.63
2135021-13502133.30833.43
3135443-13544333.41233.53
4138105-13810534.06934.19
5143770-14377035.46635.59
6138720-13872034.22134.34
45min1167580-16758041.34042.592.3841.5142.762.38
2169381-16938141.78441.96
3172652-17265242.59142.77
4172056-17205642.44442.62
5179109-17910944.18444.37
6175048-17504843.18243.36
60min1193066-19306647.62748.972.2647.8749.212.25
2194476-19447647.97548.22
3198992-19899249.08949.34
4198493-19849348.96649.21
5205627-20562750.72650.98
6200283-20028349.40849.66
90min1229203-22920356.54257.381.6556.8657.711.66
2228326-22832656.32556.65
3231470-23147057.10157.43
4232553-23255357.36857.70
5238347-23834758.79759.14
6235682-23568258.14058.47
120min1253938-25393862.64463.751.3463.0664.181.35
2255377-25537762.99963.41
3258960-25896063.88264.31
4258342-25834263.73064.15
5263571-26357165.02065.46
6260355-26035564.22764.66
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1269297-26929766.43267.351.3066.9567.881.30
2270178-27017866.65067.17
3271595-27159566.99967.53
4272915-27291567.32567.86
5278751-27875168.76569.31
6275368-27536867.93068.47
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%
116.554010983996934008664000264003864004140.15
216.454020144019684019910.01
单位质量响应值RSD%判断
24194.2024437.140.71数据可信
供试品溶液-2025030721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%
5min132562-325628.0357.933.148.047.933.16
230974-309747.6437.64
331634-316347.8067.81
433907-339078.3678.37
531765-317657.8387.84
631981-319817.8927.89
10min164855-6485516.00415.831.7416.0215.841.74
262880-6288015.51615.53
364541-6454115.92615.94
465845-6584516.24816.26
563463-6346315.66015.67
663373-6337315.63815.65
15min188160-8816021.75421.681.5121.7921.721.51
287340-8734021.55221.59
388793-8879321.91121.95
489806-8980622.16122.20
586613-8661321.37321.41
686391-8639121.31821.36
20min1107090-10709026.42626.591.3826.5026.671.39
2107769-10776926.59326.67
3109427-10942727.00227.08
4109621-10962127.05027.13
5106734-10673426.33826.41
6105944-10594426.14326.22
30min1137110-13711033.83334.001.5533.9534.121.55
2138593-13859334.19934.32
3140289-14028934.61834.74
4139872-13987234.51534.64
5135878-13587833.52933.65
6135078-13507833.33233.45
45min1172027-17202742.44942.511.5342.6342.681.53
2173272-17327242.75742.93
3175656-17565643.34543.52
4173993-17399342.93543.12
5170183-17018341.99442.17
6168448-16844841.56641.74
60min1196230-19623048.42248.711.6648.6748.961.67
2198972-19897249.09849.35
3201961-20196149.83650.09
4199215-19921549.15849.41
5195318-19531848.19748.44
6192774-19277447.56947.81
90min1231300-23130057.07657.241.2757.4057.561.27
2232857-23285757.46057.79
3236383-23638358.33058.66
4233131-23313157.52857.86
5230416-23041656.85857.18
6227624-22762456.16956.49
120min1257550-25755063.55363.571.3063.9864.001.30
2259483-25948364.03064.45
3262262-26226264.71665.15
4258458-25845863.77764.21
5255320-25532063.00363.42
6252644-25264462.34362.76
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1270191-27019166.67267.141.0467.2067.671.04
2273708-27370867.54068.07
3276157-27615768.14568.68
4272844-27284467.32767.86
5271568-27156867.01267.54
6268065-26806566.14866.67
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