贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159727189723489697649723929722659718970.13
211.179697039689649693340.06
单位质量响应值RSD%判断
87165.6586780.130.32数据可信
供试品溶液-2024092721批-依折麦布-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%
5min144916-449164.6365.2510.894.645.2510.89
256944-569445.8785.88
349766-497665.1375.14
444108-441084.5534.55
553027-530275.4745.47
656265-562655.8085.81
10min171024-710247.3317.604.007.387.664.06
276452-764527.8927.96
371967-719677.4297.49
470361-703617.2637.31
574581-745817.6987.76
677400-774007.9898.05
15min178683-786838.1227.973.788.258.113.76
281122-811228.3748.53
372277-722777.4617.60
476882-768827.9368.07
576630-766307.9108.06
677668-776688.0178.17
20min193711-937119.6739.1110.839.909.3410.64
298566-9856610.17410.42
376859-768597.9348.16
481964-819648.4618.68
580642-806428.3248.56
697930-9793010.10910.35
30min191278-912789.4229.6315.029.759.9714.71
2117508-11750812.12912.49
378495-784958.1028.41
488757-887579.1629.48
583354-833548.6048.93
6100569-10056910.38110.74
45min1115298-11529811.90110.3618.3212.3410.8017.84
2128613-12861313.27613.77
382298-822988.4958.90
485457-854578.8219.24
589495-894959.2389.66
6100834-10083410.40810.88
60min1151517-15151715.64013.1317.2216.2113.6916.86
2151233-15123315.61116.25
393551-935519.65710.15
4119443-11944312.32912.84
5120962-12096212.48613.01
6126734-12673413.08213.67
极限1178285-17828518.40318.209.2119.1418.909.06
2177397-17739718.31119.13
3144804-14480414.94715.55
4180905-18090518.67319.32
5190585-19058519.67320.34
6185979-18597919.19719.93
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.162597262593522597172589822586632592880.18
210.192588542585342586940.09
单位质量响应值RSD%判断
25520.4725387.050.38数据可信
供试品溶液-2024092721批-贝派度酸-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%
5min164506-6450625.27231.9820.7225.2731.9820.72
293070-9307036.46236.46
376648-7664830.02930.03
460208-6020823.58823.59
599369-9936938.93038.93
696048-9604837.62937.63
10min1171075-17107567.02274.5810.3467.3074.9410.39
2200636-20063678.60479.01
3188993-18899374.04274.38
4163085-16308563.89264.15
5209646-20964682.13382.57
6208833-20883381.81582.23
15min1230270-23027090.21391.142.8991.2492.323.01
2238121-23812193.28994.57
3232503-23250391.08892.24
4220602-22060286.42687.40
5238539-23853993.45394.80
6235729-23572992.35293.68
20min1240527-24052794.23295.101.3096.2697.301.45
2242640-24264095.06097.37
3242189-24218994.88397.05
4238529-23852993.44995.38
5246940-24694096.74499.13
6245675-24567596.24998.60
30min1249511-24951197.75197.300.41100.83100.560.35
2247144-24714496.824100.20
3248366-24836697.303100.53
4248735-24873597.447100.42
5249228-24922897.641101.10
6247163-24716396.832100.25
45min1250299-25029998.06097.470.80102.22101.810.64
2248919-24891997.519101.97
3249972-24997297.932102.24
4249939-24993997.919101.97
5244946-24494695.963100.51
6248752-24875297.454101.95
60min1249301-24930197.66996.971.93102.92102.381.66
2245063-24506396.009101.54
3245612-24561296.224101.62
4256470-256470100.478105.62
5244156-24415695.653101.26
6244426-24442695.759101.34
极限1244344-24434495.72795.131.09102.06101.631.03
2243933-24393395.566102.16
3246741-24674196.666103.13
4239698-23969893.907100.16
5240718-24071894.307100.98
6241542-24154294.629101.27
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