奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
18.819598896002961699604195920960240.10
28.789633296290963110.04
单位质量响应值RSD%判断
10899.4310969.360.46数据可信
供试品溶液-2024041311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%
5min192332-9233294.80894.242.0794.8194.242.07
289298-8929891.69391.69
394478-9447897.01297.01
490346-9034692.76992.77
591137-9113793.58193.58
693075-9307595.57195.57
10min195076-9507697.62695.992.3798.1596.522.37
291668-9166894.12694.64
396478-9647899.06599.60
490379-9037992.80393.32
593653-9365396.16496.68
693664-9366496.17696.71
15min194497-9449797.03196.002.5598.1097.062.54
290055-9005592.47093.50
393895-9389596.41397.50
491150-9115093.59494.63
596036-9603698.61199.67
695306-9530697.86298.93
20min195028-9502897.57694.382.5199.1895.972.50
289599-8959992.00293.55
391746-9174694.20695.83
489605-8960592.00893.56
594306-9430696.83598.44
691223-9122393.66995.28
30min195300-9530097.85694.052.61100.0196.172.59
289612-8961292.01594.07
393184-9318495.68397.83
488999-8899991.38693.45
592061-9206194.53096.67
690417-9041792.84294.97
45min195125-9512597.67694.112.32100.3796.742.28
292371-9237194.84897.42
390821-9082193.25695.94
490771-9077193.20595.77
592049-9204994.51797.18
688758-8875891.13893.78
60min191762-9176294.22392.212.2597.4695.372.22
287358-8735889.70192.80
389921-8992192.33295.53
489753-8975392.16095.25
592285-9228594.76097.95
687709-8770990.06193.21
极限190015-9001592.42992.251.9996.1995.921.95
287917-8791790.27593.87
392937-9293795.42999.14
489783-8978392.19195.79
590099-9009992.51596.23
688269-8826990.63694.29
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
18.819579395835959009581295856958390.05
28.789570095753957260.04
单位质量响应值RSD%判断
10878.4310902.730.16数据可信
供试品溶液-2024041311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%
5min169915-6991572.07872.002.4072.0872.002.40
268188-6818870.29870.30
368382-6838270.49870.50
472462-7246274.70474.70
568992-6899271.12671.13
671076-7107673.27573.27
10min184278-8427886.88585.042.2087.2985.442.20
280692-8069283.18883.58
383756-8375686.34786.74
483042-8304285.61186.03
579798-7979882.26782.66
683388-8338885.96886.37
15min186363-8636389.03587.452.5389.9288.322.51
284020-8402086.61987.47
385182-8518287.81788.69
487428-8742890.13391.02
581230-8123083.74384.60
684707-8470787.32888.21
20min185410-8541088.05287.081.4489.4388.441.44
283116-8311685.68787.02
385147-8514787.78189.14
484686-8468687.30688.70
582801-8280185.36386.68
685618-8561888.26789.64
30min187137-8713789.83387.522.7791.7089.372.74
283338-8333885.91687.73
386233-8623388.90190.75
487574-8757490.28392.16
582817-8281785.37987.17
682292-8229284.83886.70
45min185993-8599388.65388.131.4391.0290.461.43
284605-8460587.22289.51
387084-8708489.77892.12
486394-8639489.06791.44
583816-8381686.40988.68
685043-8504387.67490.01
60min184606-8460687.22486.591.9190.0889.411.90
282294-8229484.84087.61
384027-8402786.62789.47
486761-8676189.44592.32
582703-8270385.26288.01
683569-8356986.15488.97
极限185742-8574288.39585.313.0791.7488.623.01
281417-8141783.93687.18
385219-8521987.85591.18
483910-8391086.50689.88
579835-7983582.30585.52
680401-8040182.88886.19
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
18.819733097352972359715397080972300.12
28.789525495414953340.12
单位质量响应值RSD%判断
11036.3210858.091.16数据可信
供试品溶液-2024041311批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119728-1972820.23421.528.9320.2321.528.94
219863-1986320.37320.37
320053-2005320.56820.57
420988-2098821.52721.53
520591-2059121.12021.12
624684-2468425.31825.32
10min124949-2494925.58928.2110.2525.7028.3310.26
226042-2604226.71126.82
327266-2726627.96628.08
427551-2755128.25828.38
526292-2629226.96727.08
632939-3293933.78533.93
15min126359-2635927.03630.7110.7327.2930.9810.71
228771-2877129.51029.77
330478-3047831.26031.53
428889-2888929.63129.91
529254-2925430.00530.27
635895-3589536.81737.14
20min126225-2622526.89831.2711.1227.3031.7111.10
229593-2959330.35330.78
330605-3060531.39131.83
429995-2999530.76531.21
529850-2985030.61631.05
636630-3663037.57038.10
30min125945-2594526.61131.1811.2627.1731.8011.23
229886-2988630.65331.25
330360-3036031.13931.76
430472-3047231.25431.87
529259-2925930.01030.61
636489-3648937.42638.17
45min125594-2559426.25131.1712.2726.9531.9712.22
229875-2987530.64231.41
330572-3057231.35732.15
429723-2972330.48631.27
529505-2950530.26231.03
637093-3709338.04538.99
60min125780-2578026.44230.8312.0827.2931.8012.04
229204-2920429.95430.89
329516-2951630.27431.24
429153-2915329.90130.86
529884-2988430.65131.59
636819-3681937.76438.93
极限125093-2509325.73730.7711.4626.7331.9011.44
229465-2946530.22131.32
329911-2991130.67931.81
429648-2964830.40931.53
529988-2998830.75831.87
635875-3587536.79638.17
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
18.819166191734917219166191520916590.10
28.789718497197971900.01
单位质量响应值RSD%判断
10403.9711069.484.39数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2024041311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%
5min15977-59776.2566.461.936.266.461.91
26185-61856.4746.47
36286-62866.5806.58
46275-62756.5686.57
56085-60856.3696.37
66202-62026.4926.49
10min18588-85888.9899.132.699.029.162.69
29025-90259.4479.48
38772-87729.1829.22
48948-89489.3669.40
58425-84258.8198.85
68571-85718.9719.01
15min110444-1044410.93211.042.7211.0211.132.72
210869-1086911.37711.47
310420-1042010.90710.99
410940-1094011.45111.54
510364-1036410.84810.93
610246-1024610.72510.81
20min111730-1173012.27812.482.4412.4212.632.45
212377-1237712.95513.11
311690-1169012.23612.38
412206-1220612.77612.93
511763-1176312.31312.46
611790-1179012.34112.49
30min113465-1346514.09414.523.2414.3114.743.22
214534-1453415.21315.44
314165-1416514.82715.04
414040-1404014.69614.92
513402-1340214.02814.24
613613-1361314.24914.46
45min115421-1542116.14116.374.5016.4316.674.46
215949-1594916.69417.00
315069-1506915.77316.07
416855-1685517.64217.95
514915-1491515.61215.90
615634-1563416.36416.66
60min115965-1596516.71117.042.8117.0917.432.81
216943-1694317.73418.14
315772-1577216.50916.89
416698-1669817.47817.88
516013-1601316.76117.14
616313-1631317.07517.46
极限116706-1670617.48617.924.7417.9618.414.69
217826-1782618.65919.16
316141-1614116.89517.37
418234-1823419.08619.59
516508-1650817.27917.75
617323-1732318.13218.61
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