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%
116.794068704078694083674078964080244078050.14
216.804169734163084166400.12
单位质量响应值RSD%判断
24288.5624800.001.48数据可信
供试品溶液-2025050421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%
5min144042-4404210.7579.986.1510.769.986.14
241320-4132010.09210.09
341353-4135310.10010.10
442437-4243710.36510.36
539044-390449.5369.54
636964-369649.0289.03
10min177829-7782919.00919.022.6619.0319.042.65
279266-7926619.36019.38
378725-7872519.22819.24
480477-8047719.65619.67
575957-7595718.55218.57
675011-7501118.32118.34
15min1109474-10947426.73826.302.1026.7926.352.10
2109739-10973926.80226.85
3107612-10761226.28326.33
4109365-10936526.71126.76
5105316-10531625.72225.77
6104575-10457525.54125.59
20min1133857-13385732.69332.633.1732.7932.723.16
2133148-13314832.52032.61
3140797-14079734.38834.48
4134320-13432032.80632.90
5131550-13155032.13032.22
6127901-12790131.23831.33
30min1171401-17140141.86341.191.7842.0141.341.78
2170669-17066941.68441.83
3167079-16707940.80740.96
4171286-17128641.83541.98
5167687-16768740.95641.10
6163858-16385840.02040.16
45min1209365-20936551.13550.521.8751.3550.731.87
2210179-21017951.33451.55
3206009-20600950.31550.53
4210834-21083451.49451.71
5202518-20251849.46349.67
6202184-20218449.38149.59
60min1235080-23508057.41657.311.9157.7257.611.91
2240256-24025658.68058.98
3232554-23255456.79957.10
4239181-23918158.41758.72
5232196-23219656.71157.01
6228559-22855955.82356.11
90min1274621-27462167.07366.291.6567.4766.681.65
2275311-27531167.24167.64
3268852-26885265.66466.06
4275786-27578667.35767.76
5269128-26912865.73166.12
6264806-26480664.67665.06
120min1298589-29858972.92772.181.7373.4472.691.73
2300518-30051873.39873.91
3288494-28849470.46170.97
4300577-30057773.41273.93
5293692-29369271.73172.23
6291371-29137171.16471.65
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1329400-32940080.45279.282.4281.0879.912.41
2329090-32909080.37681.01
3323118-32311878.91879.54
4333211-33321181.38382.02
5311194-31119476.00576.62
6321681-32168178.56779.18
240min1348239-34823985.05384.151.4085.8284.911.40
2346793-34679384.70085.47
3342250-34225083.59184.35
4350904-35090485.70486.48
5339753-33975382.98183.72
6339281-33928182.86583.60
极限1353823-35382386.41785.131.4087.3386.031.40
2346337-34633784.58985.50
3344345-34434584.10285.00
4355394-35539486.80187.72
5347051-34705184.76385.65
6344308-34430884.09384.97
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%
116.794129674133984136964126664128184131090.11
216.804150714155734153220.09
单位质量响应值RSD%判断
24604.4724721.550.34数据可信
供试品溶液-2025050621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%
5min142069-4206910.2249.974.2810.229.974.30
238821-388219.4359.43
341575-4157510.10410.10
443478-4347810.56710.57
539259-392599.5419.54
641000-410009.9659.96
10min177979-7797918.95218.762.4918.9718.782.50
274853-7485318.19218.21
378431-7843119.06219.08
479906-7990619.42019.44
575457-7545718.33918.35
676522-7652218.59818.61
15min1108040-10804026.25825.881.7126.3125.931.71
2104024-10402425.28225.33
3107477-10747726.12126.17
4108544-10854426.38026.43
5104973-10497325.51225.56
6105783-10578325.70925.76
20min1132190-13219032.12731.671.4332.2231.761.43
2127355-12735530.95231.04
3131824-13182432.03832.13
4131422-13142231.94032.03
5129194-12919431.39931.49
6129900-12990031.57131.66
30min1167727-16772740.76440.510.9540.9140.650.96
2163610-16361039.76339.90
3167468-16746840.70140.85
4167334-16733440.66840.82
5167547-16754740.72040.86
6166394-16639440.44040.58
45min1203754-20375449.52049.770.9549.7349.980.96
2202115-20211549.12249.33
3205152-20515249.86050.07
4207634-20763450.46350.68
5203906-20390649.55749.77
6206088-20608850.08750.30
60min1216025-21602552.50255.993.1052.8056.293.08
2231786-23178656.33356.62
3231981-23198156.38056.68
4233766-23376656.81457.11
5234963-23496357.10557.40
6233761-23376156.81357.11
90min1269040-26904065.38765.250.9965.7765.640.98
2265801-26580164.60064.98
3270834-27083465.82366.21
4272169-27216966.14766.54
5266346-26634664.73265.12
6266613-26661364.79765.19
120min1292587-29258771.11071.680.5771.6072.180.57
2294284-29428471.52272.01
3297665-29766572.34472.84
4294670-29467071.61672.12
5295657-29565771.85672.35
6294728-29472871.63072.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1320938-32093878.00079.110.9778.6179.720.96
2324882-32488278.95879.57
3329788-32978880.15180.77
4328132-32813279.74880.37
5325269-32526979.05379.67
6323997-32399778.74379.36
240min1343951-34395183.59383.270.6084.3384.020.59
2342490-34249083.23883.98
3345511-34551183.97284.73
4339438-33943882.49683.25
5342293-34229383.19083.94
6342019-34201983.12383.87
极限1347570-34757084.47383.841.3285.3584.721.31
2344046-34404683.61684.50
3349821-34982185.02085.91
4346881-34688184.30585.20
5344802-34480283.80084.68
6336691-33669181.82982.71
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101242-202302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%
116.794097864095574099714099474094724097470.06
216.804141894087254114570.94
单位质量响应值RSD%判断
24404.2324491.490.26数据可信
供试品溶液-2025050821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%
5min140231-402319.8649.394.989.869.394.96
236165-361658.8678.87
336985-369859.0689.07
440909-4090910.03010.03
538302-383029.3919.39
637163-371639.1119.11
10min175000-7500018.38818.042.4618.4018.062.46
273305-7330517.97317.99
371969-7196917.64517.66
471886-7188617.62517.64
576459-7645918.74618.76
672865-7286517.86517.88
15min1105635-10563525.89925.462.1125.9525.502.12
2103762-10376225.44025.48
3100683-10068324.68524.73
4101759-10175924.94924.99
5105893-10589325.96226.01
6105319-10531925.82225.87
20min1129398-12939831.72531.351.1331.8231.441.13
2127357-12735731.22531.31
3127347-12734731.22231.31
4125739-12573930.82830.92
5129571-12957131.76831.86
6127803-12780331.33431.42
30min1163979-16397940.20440.310.9340.3540.460.94
2164785-16478540.40140.54
3163334-16333440.04640.18
4162334-16233439.80039.94
5166506-16650640.82340.97
6165619-16561940.60640.75
45min1203627-20362749.92450.030.5650.1350.240.56
2203500-20350049.89350.10
3203166-20316649.81150.02
4203306-20330649.84650.05
5206056-20605650.52050.73
6204732-20473250.19550.40
60min1231115-23111556.66456.980.7756.9657.270.77
2233011-23301157.12957.42
3231529-23152956.76557.05
4230041-23004156.40056.69
5234257-23425757.43457.73
6234437-23443757.47857.77
90min1268376-26837665.79966.260.5366.1966.650.53
2269992-26999266.19566.58
3270308-27030866.27366.66
4271434-27143466.54966.93
5272236-27223666.74667.14
6269186-26918665.99866.39
120min1291158-29115871.38572.410.9471.8872.900.93
2294399-29439972.17972.67
3293782-29378272.02872.52
4296581-29658172.71473.21
5297293-29729372.88973.39
6298765-29876573.25073.75
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1321551-32155178.83680.000.8179.4580.610.80
2326941-32694180.15880.77
3326529-32652980.05780.67
4327382-32738280.26680.88
5325887-32588779.90080.52
6329429-32942980.76881.39
240min1343738-34373884.27684.411.0185.0285.161.00
2338379-33837982.96283.71
3343541-34354184.22884.97
4347714-34771485.25186.00
5347752-34775285.26086.02
6344664-34466484.50385.26
极限1347506-34750685.20085.960.7886.0986.850.78
2348625-34862585.47486.36
3349193-34919385.61486.50
4354939-35493987.02287.91
5351159-35115986.09686.99
6352200-35220086.35187.25
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