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 16.373959753962003954403958293952833957450.10
2 16.343969783963853966820.11
单位质量响应值RSD%判断
24175.0224276.740.30数据可信
供试品溶液-2025032921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%
5min141225-4122510.21010.142.8510.2110.142.88
240489-4048910.02810.03
342258-4225810.46610.47
441303-4130310.23010.23
541517-4151710.28310.28
638861-388619.6259.62
10min183036-8303620.56620.731.4920.5820.741.49
284139-8413920.83920.86
385689-8568921.22321.24
482302-8230220.38420.40
584179-8417920.84920.87
682738-8273820.49220.51
15min1114740-11474028.41828.400.8328.4728.450.84
2114434-11443428.34228.39
3116378-11637828.82328.88
4114836-11483628.44128.49
5113867-11386728.20128.25
6113783-11378328.18128.23
20min1139786-13978634.62134.600.4134.7234.700.42
2139539-13953934.56034.66
3140664-14066434.83834.94
4139082-13908234.44634.54
5139989-13998934.67134.77
6139252-13925234.48934.59
30min1176395-17639543.68843.480.7943.8443.630.79
2174246-17424643.15643.31
3177070-17707043.85544.01
4174250-17425043.15743.31
5176912-17691243.81643.97
6174396-17439643.19343.35
45min1213966-21396652.99352.790.6753.2253.020.67
2211990-21199052.50452.73
3212983-21298352.75052.98
4213436-21343652.86253.09
5215265-21526553.31553.54
6211270-21127052.32552.55
60min1239188-23918859.24059.340.7459.5659.650.74
2237548-23754858.83459.15
3240565-24056559.58159.90
4238253-23825359.00859.32
5242484-24248460.05660.37
6239404-23940459.29359.61
90min1270592-27059267.01867.960.9467.4368.380.94
2274836-27483668.06968.48
3274312-27431267.93968.36
4275558-27555868.24768.66
5278233-27823368.91069.33
6272935-27293567.59868.01
120min1299131-29913174.08673.720.9074.6174.250.89
2294209-29420972.86773.39
3298426-29842673.91174.44
4296060-29606073.32573.85
5301724-30172474.72875.26
6296490-29649073.43273.96
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1327026-32702680.99580.640.7681.6581.290.76
2322914-32291479.97680.62
3326982-32698280.98481.64
4324317-32431780.32480.97
5329043-32904381.49482.15
6323165-32316580.03880.69
240min1343941-34394185.18484.870.6885.9785.660.68
2341935-34193584.68785.47
3342711-34271184.87985.67
4343116-34311684.98085.76
5345646-34564685.60686.40
6338700-33870083.88684.67
极限1349408-34940886.53885.520.9087.4786.440.90
2343554-34355485.08886.01
3345585-34558585.59186.52
4342177-34217784.74785.67
5348483-34848386.30987.25
6342492-34249284.82585.75
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 16.373966553966473965913962963959913964360.08
2 16.344017484019574018520.04
单位质量响应值RSD%判断
24217.2324593.151.09数据可信
供试品溶液-2025032921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%
5min140604-406049.98310.052.499.9810.052.51
241774-4177410.27110.27
341256-4125610.14310.14
439066-390669.6059.60
540853-4085310.04410.04
641796-4179610.27610.28
10min184427-8442720.75820.671.6620.7720.691.66
285491-8549121.01921.04
384193-8419320.70020.72
481444-8144420.02420.04
584857-8485720.86320.88
684129-8412920.68420.70
15min1115251-11525128.33628.251.2228.3928.301.23
2116378-11637828.61328.67
3115383-11538328.36928.42
4114392-11439228.12528.17
5115577-11557728.41628.47
6112341-11234127.62127.67
20min1140201-14020134.47034.231.0134.5734.331.01
2141017-14101734.67134.77
3138574-13857434.07034.17
4138589-13858934.07434.17
5139922-13992234.40234.50
6137156-13715633.72233.82
30min1176978-17697843.51343.150.7043.6743.300.70
2175679-17567943.19343.35
3176231-17623143.32943.48
4175013-17501343.02943.18
5175592-17559243.17243.33
6173419-17341942.63742.79
45min1215667-21566753.02552.460.9453.2552.680.93
2214834-21483452.82053.05
3214000-21400052.61552.84
4213653-21365352.53052.75
5211489-21148951.99852.23
6210462-21046251.74551.97
60min1242767-24276759.68859.200.8660.0059.510.86
2241922-24192259.48059.80
3241139-24113959.28759.60
4242295-24229559.57259.88
5237612-23761258.42058.74
6238886-23888658.73359.04
90min1277168-27716868.14667.470.9468.5667.880.94
2275908-27590867.83668.25
3275696-27569667.78468.20
4275409-27540967.71368.12
5271369-27136966.72067.13
6271063-27106366.64567.05
120min1302891-30289174.47073.590.8375.0074.120.82
2300737-30073773.94074.47
3300157-30015773.79874.32
4298858-29885873.47874.00
5297096-29709673.04573.57
6296202-29620272.82573.35
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1327677-32767780.56480.130.6081.2280.780.60
2328571-32857180.78481.44
3325912-32591280.13080.78
4325537-32553780.03880.68
5323636-32363679.57080.22
6324083-32408379.68080.32
240min1344627-34462784.73184.400.7585.5285.180.75
2345075-34507584.84285.63
3342359-34235984.17484.96
4346536-34653685.20185.98
5339758-33975883.53484.31
6341279-34127983.90884.68
极限1351159-35115986.33785.240.9587.2786.160.95
2348733-34873385.74186.67
3346763-34676385.25786.18
4347684-34768485.48386.41
5343063-34306384.34785.26
6342721-34272184.26385.18
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 16.374009554008714010094002184004174006940.09
2 16.343997513997313997410.01
单位质量响应值RSD%判断
24477.3424463.950.04数据可信
供试品溶液-2025032921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%
5min140267-402679.8739.974.089.879.974.06
239776-397769.7539.75
343653-4365310.70310.70
441392-4139210.14910.15
539175-391759.6059.61
639628-396289.7169.72
10min176629-7662918.78918.921.0518.8118.941.05
276159-7615918.67418.69
377276-7727618.94718.97
478186-7818619.17119.19
576795-7679518.83018.85
678052-7805219.13819.15
15min1105607-10560725.89425.571.2925.9425.621.30
2102141-10214125.04425.09
3105023-10502325.75125.80
4104096-10409625.52325.57
5103445-10344525.36425.41
6105462-10546225.85825.91
20min1127237-12723731.19730.890.7831.2930.980.78
2124879-12487930.61930.71
3125938-12593830.87930.97
4127127-12712731.17031.26
5125394-12539430.74630.84
6125375-12537530.74130.83
30min1160970-16097039.46939.200.9139.6139.340.91
2157564-15756438.63338.77
3159728-15972839.16439.31
4160440-16044039.33939.48
5158971-15897138.97839.12
6161557-16155739.61239.75
45min1196631-19663148.21248.000.8448.4248.200.84
2193406-19340647.42247.63
3196548-19654848.19248.40
4195679-19567947.97948.19
5194336-19433647.65047.86
6197895-19789548.52248.73
60min1222223-22222354.48754.300.7554.7854.590.75
2218819-21881953.65353.94
3222096-22209654.45654.75
4220980-22098054.18254.47
5220906-22090654.16454.45
6223689-22368954.84755.14
90min1255477-25547762.64162.500.7363.0262.880.72
2252386-25238661.88362.26
3255338-25533862.60762.99
4254180-25418062.32362.70
5254155-25415562.31762.69
6257894-25789463.23363.61
120min1277509-27750968.04368.140.9168.5368.620.91
2275160-27516067.46767.94
3278854-27885468.37368.86
4277180-27718067.96268.45
5276267-27626767.73868.22
6282347-28234769.22969.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1303100-30310074.31874.510.5574.9275.100.55
2302666-30266674.21174.80
3306163-30616375.06975.67
4302736-30273674.22874.82
5302751-30275174.23274.82
6305819-30581974.98475.59
240min1322346-32234679.03778.750.5679.7679.480.56
2318317-31831778.04978.76
3322048-32204878.96479.69
4319982-31998278.45779.18
5321270-32127078.77379.49
6323180-32318079.24179.97
极限1324116-32411679.47179.500.5580.3280.350.55
2321369-32136978.79779.64
3325037-32503779.69680.55
4323660-32366079.35980.21
5324523-32452379.57080.42
6326711-32671180.10780.97
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