托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.4410005699831999579991099951999410.09
216.399998999820999040.12
单位质量响应值RSD%判断
6079.146095.420.19数据可信
供试品溶液-2K72SDB2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%
5min19538-95389.4019.695.549.409.695.53
29055-90558.9258.93
310216-1021610.07010.07
410611-1061110.45910.46
59660-96609.5229.52
69879-98799.7379.74
10min123562-2356223.22423.662.0223.2823.722.03
223262-2326222.92922.98
324343-2434323.99424.05
424500-2450024.14924.21
524120-2412023.77423.83
624235-2423523.88823.94
15min132073-3207331.61332.041.7431.7932.231.74
231957-3195731.49931.68
332126-3212631.66531.85
433318-3331832.84033.03
532538-3253832.07232.26
633047-3304732.57332.76
20min138725-3872538.17038.260.5538.5338.620.53
239145-3914538.58438.94
338846-3884638.28938.65
438647-3864738.09338.47
538573-3857338.02038.38
638942-3894238.38438.75
30min146901-4690146.22947.311.5946.8047.881.57
248022-4802247.33447.90
348558-4855847.86248.44
447250-4725046.57347.16
548468-4846847.77348.35
648763-4876348.06448.64
45min156753-5675355.93956.711.7056.7757.551.68
256656-5665655.84456.67
357851-5785157.02257.87
458823-5882357.98058.82
558464-5846457.62658.47
656677-5667755.86456.71
60min164944-6494464.01364.912.7465.1566.062.70
264502-6450263.57764.72
369384-6938468.38969.55
465739-6573964.79765.96
564801-6480163.87265.03
665748-6574864.80565.96
90min174098-7409873.03672.521.5474.5374.041.52
271673-7167370.64572.14
372848-7284871.80473.34
474656-7465673.58675.11
573733-7373372.67674.19
674457-7445773.39074.91
120min178605-7860577.47877.811.5379.3879.731.51
278071-7807176.95278.84
379741-7974178.59880.54
480525-8052579.37181.31
577236-7723676.12978.05
679484-7948478.34480.27
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min184187-8418782.98083.891.1885.3186.241.15
286090-8609084.85687.17
385818-8581884.58886.96
484144-8414482.93885.31
584263-8426383.05585.40
686144-8614484.90987.27
240min188550-8855087.28186.711.8590.0789.521.81
286102-8610284.86887.65
390317-9031789.02291.87
488421-8842187.15389.99
586101-8610184.86787.67
688318-8831887.05289.88
300min188692-8869287.42087.651.6990.6990.941.66
288044-8804486.78290.04
390022-9002288.73192.07
489835-8983588.54791.87
586478-8647885.23888.51
690458-9045889.16192.48
360min192142-9214290.82187.104.0994.5890.883.91
290159-9015988.86692.60
388630-8863087.35991.19
490836-9083689.53493.35
586063-8606384.82988.58
682349-8234981.16884.98
极限190379-9037989.08388.761.4193.3593.031.37
288144-8814486.88091.11
389531-8953188.24792.57
491569-9156990.25694.57
589469-8946988.18692.41
691227-9122789.91994.18
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.449987799849998609993099880998790.04
216.391014421014861014640.04
单位质量响应值RSD%判断
6075.366190.601.33数据可信
供试品溶液-3A75SDB1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%
5min19512-95129.3079.904.139.319.904.11
210386-1038610.16210.16
39808-98089.5969.60
410612-1061210.38310.38
59977-99779.7629.76
610386-1038610.16210.16
10min123481-2348122.97423.752.2623.0323.802.26
224215-2421523.69223.75
323856-2385623.34123.39
424776-2477624.24124.30
524368-2436823.84223.90
624928-2492824.39024.45
15min132895-3289532.18532.261.0732.3632.451.07
232578-3257831.87432.06
332573-3257331.87032.05
433175-3317532.45932.65
533230-3323032.51232.70
633401-3340132.68032.87
20min137975-3797537.15538.251.8337.5138.621.82
238761-3876137.92438.29
339523-3952338.66939.03
439579-3957938.72439.10
538809-3880937.97138.34
639912-3991239.05039.42
30min148879-4887947.82348.231.3248.3948.811.30
250094-5009449.01249.59
349555-4955548.48549.06
449283-4928348.21948.81
549705-4970548.63249.21
648273-4827347.23047.82
45min156190-5619054.97656.361.8155.8157.201.79
257527-5752756.28557.13
358688-5868857.42158.26
458840-5884057.56958.42
557589-5758956.34557.19
656771-5677155.54556.40
60min165525-6552564.11063.631.7265.2564.801.70
263313-6331361.94663.11
364473-6447363.08164.24
466680-6668065.24066.42
565124-6512463.71864.88
665116-6511663.71064.87
90min173743-7374372.15072.511.4673.6474.021.43
273836-7383672.24173.75
374697-7469773.08474.60
473108-7310871.52973.07
573273-7327371.69173.21
675992-7599274.35175.87
120min180945-8094579.19777.012.1481.0978.922.09
277636-7763675.95977.87
377787-7778776.10778.03
480228-8022878.49580.43
576540-7654074.88776.80
679108-7910877.39979.33
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min185114-8511483.27683.241.3985.6185.591.36
284864-8486483.03185.36
386217-8621784.35586.70
486645-8664584.77487.15
583855-8385582.04484.37
683798-8379881.98884.35
240min184911-8491183.07785.132.1185.8787.942.06
286354-8635484.48987.28
386090-8609084.23187.04
489943-8994388.00090.84
588445-8844586.53589.32
686319-8631984.45587.27
300min188286-8828686.37987.272.1789.6490.542.10
289284-8928487.35690.61
386006-8600684.14987.43
491714-9171489.73393.06
590229-9022988.28091.55
689630-8963087.69490.98
360min188072-8807286.17088.311.6489.9192.081.60
290938-9093888.97492.72
389761-8976187.82291.57
492491-9249190.49394.32
590636-9063688.67992.44
689688-8968887.75191.52
极限188346-8834686.43886.163.3990.6590.413.24
290044-9004488.09992.34
389832-8983287.89292.13
490947-9094788.98393.32
586134-8613484.27488.52
683039-8303981.24685.50
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