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%
116.483976493972253980423981143975583977180.10
216.553980343976943978640.07
单位质量响应值RSD%判断
24133.3724040.120.28数据可信
供试品溶液-2025050421批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1363741-36374190.51783.288.3890.5283.288.38
2300923-30092374.88574.89
3352581-35258187.74087.74
4353619-35361987.99988.00
5337803-33780384.06384.06
6299224-29922474.46274.46
10min1387119-38711996.33596.012.2396.4996.142.24
2377049-37704993.82993.95
3393147-39314797.83597.98
4393182-39318297.84497.99
5390963-39096397.29297.43
6373336-37333692.90593.03
15min1389984-38998497.04897.641.0297.3697.941.02
2387521-38752196.43596.72
3396194-39619498.59398.90
4395318-39531898.37598.69
5396217-39621798.59998.90
6388935-38893596.78797.07
20min1390881-39088197.27197.980.8197.7498.440.81
2389848-38984897.01497.46
3396253-39625398.60899.08
4396121-39612198.57599.05
5397162-39716298.83499.30
6392043-39204397.56098.00
30min1390767-39076797.24398.130.7897.8898.750.78
2390464-39046497.16897.77
3396896-39689698.76899.41
4396610-39661098.69799.33
5397026-39702698.80199.43
6394177-39417798.09298.69
45min1390349-39034997.13998.090.7897.9498.880.78
2390258-39025897.11697.88
3396197-39619798.59499.40
4396660-39666098.70999.51
5396673-39667398.71399.51
6394884-39488498.26799.03
60min1390997-39099797.30098.070.7898.2699.020.79
2389492-38949296.92697.85
3396406-39640698.64699.61
4396691-39669198.71799.68
5395963-39596398.53699.50
6395030-39503098.30499.23
极限1390361-39036197.14298.271.0398.2699.381.03
2389057-38905796.81797.91
3397798-39779898.993100.12
4397117-39711798.82399.95
5396647-39664798.70699.83
6398272-39827299.111100.20
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%
116.483988513990813991513981203993183989040.12
216.553990103993043991570.06
单位质量响应值RSD%判断
24205.3424118.250.26数据可信
供试品溶液-2025050421批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1381415-38141594.62186.599.7994.6286.599.79
2357721-35772188.74388.74
3362629-36262989.96089.96
4378308-37830893.85093.85
5298462-29846274.04274.04
6315754-31575478.33278.33
10min1405901-405901100.69598.242.05100.8598.382.06
2395870-39587098.20798.35
3396076-39607698.25898.41
4398870-39887098.95199.11
5381209-38120994.57094.69
6397985-39798598.73198.86
15min1407042-407042100.97899.410.83101.3099.720.84
2399327-39932799.06499.38
3398123-39812398.76699.08
4401250-40125099.54199.86
5398332-39833298.81899.10
6400343-40034399.31699.61
20min1407450-407450101.08099.911.03101.57100.381.03
2407941-407941101.201101.68
3397412-39741298.58999.07
4401697-40169799.652100.14
5401251-40125199.54299.99
6400634-40063499.38999.85
30min1411551-411551102.097100.001.15102.76100.641.16
2404337-404337100.307100.95
3398029-39802998.74299.39
4401957-40195799.717100.37
5402151-40215199.765100.38
6400544-40054499.36699.99
45min1408436-408436101.32499.640.93102.16100.440.94
2400971-40097199.472100.28
3397399-39739998.58699.39
4400708-40070899.407100.23
5402490-40249099.849100.63
6399842-39984299.19299.98
60min1407639-407639101.12699.520.91102.13100.490.91
2401122-40112299.510100.49
3396368-39636898.33099.30
4400318-40031899.310100.30
5400948-40094899.467100.41
6400495-40049599.354100.31
极限1407604-407604101.11899.481.00102.29100.621.00
2403212-403212100.028101.17
3396222-39622298.29499.43
4399588-39958899.129100.28
5400862-40086299.445100.56
6398535-39853598.86899.99
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%
116.483979563985763981623984603980453982400.07
216.554012994015704014340.05
单位质量响应值RSD%判断
24165.0524255.830.27数据可信
供试品溶液-2025050621批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1317737-31773778.66581.529.7278.6781.529.72
2364545-36454590.25490.25
3359702-35970289.05589.06
4292979-29297972.53672.54
5294476-29447672.90672.91
6346242-34624285.72385.72
10min1393427-39342797.40597.142.9097.5497.282.91
2399174-39917498.82898.98
3405085-405085100.291100.44
4392943-39294397.28597.41
5371449-37144991.96392.08
6392092-39209297.07497.22
15min1398389-39838998.63398.721.5198.9399.021.52
2401118-40111899.30999.62
3407401-407401100.864101.18
4401113-40111399.30899.59
5390203-39020396.60696.88
6394217-39421797.60097.90
20min1399856-39985698.99698.991.2699.4599.451.27
2402587-40258799.672100.15
3406751-406751100.703101.19
4401613-40161399.43199.88
5393502-39350297.42397.86
6394626-39462697.70298.17
30min1398487-39848798.65798.981.2899.2899.611.28
2403646-40364699.935100.58
3406666-406666100.682101.33
4401539-40153999.413100.03
5394413-39441397.64998.25
6393961-39396197.53798.17
45min1399746-39974698.96998.861.2499.7699.651.25
2402230-40223099.584100.40
3406119-406119100.547101.37
4400436-40043699.14099.92
5394565-39456597.68698.45
6392719-39271997.22998.02
60min1399420-39942098.88898.691.2599.8499.641.26
2401901-40190199.503100.48
3405707-405707100.445101.43
4398451-39845198.64999.59
5393679-39367997.46798.39
6392541-39254197.18598.14
极限1396980-39698098.28498.371.1499.4099.491.15
2401904-40190499.503100.65
3402808-40280899.727100.88
4397725-39772598.46999.58
5392674-39267497.21898.30
6391906-39190697.02898.14
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%
116.484010854015064017764012554020014015250.10
216.554001733999274000500.05
单位质量响应值RSD%判断
24364.3824172.210.56数据可信
供试品溶液-2025050621批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1378102-37810293.38885.6910.8593.3985.7010.85
2383240-38324094.65894.66
3345051-34505185.22585.23
4358541-35854188.55788.56
5337306-33730683.31283.31
6279445-27944569.02169.02
10min1399999-39999998.79796.852.3498.9596.992.36
2401320-40132099.12399.28
3392096-39209696.84596.99
4395210-39521097.61497.76
5387556-38755695.72495.86
6376529-37652993.00093.11
15min1399525-39952598.68097.980.6299.0098.280.63
2399891-39989198.77099.09
3396148-39614897.84698.15
4394794-39479497.51197.82
5395746-39574697.74698.04
6394081-39408197.33597.61
20min1399556-39955698.68798.190.4899.1798.660.48
2399850-39985098.76099.25
3396843-39684398.01798.48
4394882-39488297.53398.01
5396847-39684798.01898.48
6397236-39723698.11498.55
30min1399091-39909198.57398.090.4699.2298.720.47
2399107-39910798.57799.23
3395904-39590497.78598.42
4394538-39453897.44898.08
5396570-39657097.95098.57
6397724-39772498.23598.83
45min1399126-39912698.58198.130.5399.3998.930.54
2399910-39991098.77599.59
3396308-39630897.88598.68
4394444-39444497.42598.22
5398141-39814198.33899.13
6395909-39590997.78798.55
60min1397228-39722898.11297.730.3899.0998.680.38
2397596-39759698.20399.18
3394355-39435597.40398.36
4394138-39413897.34998.31
5394818-39481897.51798.47
6395864-39586497.77698.70
极限1396969-39696998.04897.460.5199.1998.580.52
2396086-39608697.83098.98
3393025-39302597.07498.19
4391646-39164696.73497.86
5395602-39560297.71198.83
6394204-39420497.36698.45
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