依折麦布贝派度酸片项目信息
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%
111.129727189723489697649723929722659718970.13
211.079697039689649693340.06
单位质量响应值RSD%判断
87400.8187564.050.14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%
5min144916-449164.6095.2210.894.615.2210.83
256944-569445.8445.84
349766-497665.1075.11
444108-441084.5264.53
553027-530275.4425.44
656265-562655.7745.77
10min171024-710247.2897.564.017.347.614.06
276452-764527.8467.91
371967-719677.3857.44
470361-703617.2207.27
574581-745817.6547.71
677400-774007.9438.01
15min178683-786838.0757.923.788.218.073.75
281122-811228.3258.48
372277-722777.4177.56
476882-768827.8908.02
576630-766307.8648.01
677668-776687.9708.12
20min193711-937119.6179.0610.849.849.2910.64
298566-9856610.11510.36
376859-768597.8878.11
481964-819648.4118.63
580642-806428.2768.51
697930-9793010.05010.29
30min191278-912789.3678.2351.229.708.5749.41
2117508-11750812.05912.42
3-0.0000.31
488757-887579.1089.42
583354-833548.5548.88
6100569-10056910.32010.67
45min1115298-11529811.83210.3018.3212.2610.7218.06
2128613-12861313.19813.69
382298-822988.4458.75
485457-854578.7709.18
589495-894959.1849.60
6100834-10083410.34810.81
60min1151517-15151715.54913.0617.2316.1113.6017.08
2151233-15123315.52016.16
393551-935519.60010.00
4119443-11944312.25712.77
5120962-12096212.41312.94
6126734-12673413.00613.59
极限1178285-17828518.29618.099.2119.0318.789.25
2177397-17739718.20519.01
3144804-14480414.86015.37
4180905-18090518.56519.21
5190585-19058519.55820.22
6185979-18597919.08519.81
依折麦布贝派度酸片项目信息
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%
110.182597262593522597172589822586632592880.18
210.222588542585342586940.09
单位质量响应值RSD%判断
25470.3325312.520.44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%
5min164506-6450625.33432.0620.7225.3332.0620.72
293070-9307036.55236.55
376648-7664830.10230.10
460208-6020823.64623.65
599369-9936939.02639.03
696048-9604837.72137.72
10min1171075-17107567.18774.7710.3467.4775.1210.39
2200636-20063678.79779.20
3188993-18899374.22474.56
4163085-16308564.04964.31
5209646-20964682.33582.77
6208833-20883382.01682.44
15min1230270-23027090.43591.362.8991.4692.553.01
2238121-23812193.51894.80
3232503-23250391.31292.47
4220602-22060286.63887.61
5238539-23853993.68395.03
6235729-23572992.57993.91
20min1240527-24052794.46395.341.3096.5097.541.45
2242640-24264095.29397.61
3242189-24218995.11697.29
4238529-23852993.67995.62
5246940-24694096.98299.37
6245675-24567596.48598.84
30min1249511-24951197.99286.4231.52101.0789.6830.39
2247144-24714497.062100.44
378495-7849530.82834.06
4248735-24873597.687100.66
5249228-24922897.880101.35
6247163-24716397.069100.50
45min1250299-25029998.30197.710.80102.47101.940.62
2248919-24891997.759102.22
3249972-24997298.173101.75
4249939-24993998.160102.22
5244946-24494696.199100.75
6248752-24875297.694102.20
60min1249301-24930197.90997.201.93103.17102.511.75
2245063-24506396.245101.79
3245612-24561296.460101.12
4256470-256470100.725105.88
5244156-24415695.889101.51
6244426-24442695.995101.59
极限1244344-24434495.96295.371.09102.31101.750.85
2243933-24393395.801102.41
3246741-24674196.904102.64
4239698-23969894.138100.41
5240718-24071894.538101.23
6241542-24154294.862101.52
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