依折麦布片项目信息
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
110.212830911283193028313692831793282992528311860.03
210.292850821285611028534660.14
单位质量响应值RSD%判断
277295.40277304.760.01数据可信
供试品溶液-2024053011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%
5min12218193-221819371.26669.832.4471.2769.832.44
22195325-219532570.53170.53
32211015-221101571.03671.04
42159274-215927469.37369.37
52183083-218308370.13870.14
62074478-207447866.64966.65
10min12715877-271587787.25685.501.4187.3785.621.41
22663464-266346485.57285.69
32680473-268047386.11886.24
42649749-264974985.13185.25
52655556-265555685.31885.43
62602335-260233583.60883.72
15min12843460-284346091.35590.201.2091.6290.461.20
22808975-280897590.24790.51
32800728-280072889.98290.24
42844994-284499491.40491.66
52789961-278996189.63689.89
62756761-275676188.56988.82
20min12922654-292265493.89992.331.4394.3292.741.43
22867189-286718992.11792.53
32858937-285893791.85292.26
42924336-292433693.95394.36
52845662-284566291.42591.83
62824673-282467390.75191.15
30min13005593-300559396.56494.771.4897.1495.341.48
22962868-296286895.19195.76
32929828-292982894.13094.69
42988902-298890296.02796.59
52918949-291894993.78094.34
62892701-289270192.93793.49
45min13043631-304363197.78696.481.2698.5297.201.26
23041713-304171397.72498.45
32971810-297181095.47896.20
43025204-302520497.19497.92
52964877-296487795.25695.97
62970770-297077095.44596.15
60min13051874-305187498.05196.991.1098.9597.871.10
23056366-305636698.19599.08
32984361-298436195.88296.76
43035525-303552597.52598.41
52985884-298588495.93196.81
62998879-299887996.34897.21
极限13075143-307514398.79898.790.8399.8699.830.83
23114390-3114390100.059101.11
33045564-304556497.84898.89
43092273-309227399.349100.40
53067293-306729398.54699.58
63054248-305424898.12799.15
依折麦布片项目信息
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
110.212836764283671228349582835269283623428359870.03
210.292837576284268328401300.13
单位质量响应值RSD%判断
277765.62276008.750.45数据可信
供试品溶液-2024053011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%
5min12137780-213778068.78668.043.1768.7968.043.17
22094946-209494667.40767.41
32211330-221133071.15271.15
42011284-201128464.71664.72
52142594-214259468.94168.94
62089392-208939267.22967.23
10min12663727-266372785.70985.171.3185.8285.281.31
22614413-261441384.12284.23
32671919-267191985.97286.09
42607504-260750483.90084.01
52693681-269368186.67386.79
62630074-263007484.62684.74
15min12808156-280815690.35690.020.9690.6190.280.96
22785414-278541489.62489.88
32808778-280877890.37690.64
42779835-277983589.44589.69
52839839-283983991.37591.63
62764599-276459988.95489.21
20min12875910-287591092.53692.221.0992.9492.631.09
22864385-286438592.16592.57
32890117-289011792.99393.41
42838703-283870391.33991.74
52905036-290503693.47393.88
62822531-282253190.81891.22
30min12962908-296290895.33594.940.9795.9095.500.98
22953865-295386595.04495.60
32976054-297605495.75896.33
42914551-291455193.77994.33
52979145-297914595.85896.43
62916524-291652493.84394.40
45min13003771-300377196.65096.420.5797.3797.140.58
22987383-298738396.12396.84
33014215-301421596.98697.71
42968491-296849195.51596.22
53011049-301104996.88497.61
62995703-299570396.39097.10
60min12994054-299405496.33796.660.4297.2297.540.42
22992302-299230296.28197.16
33022211-302221197.24398.13
42994153-299415396.34197.21
53012795-301279596.94097.83
63009782-300978296.84397.71
极限13026758-302675897.39097.840.6198.4398.880.61
23024899-302489997.33098.36
33058685-305868598.41799.47
43036110-303611097.69198.72
53068317-306831798.72799.78
63029363-302936397.47498.50
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