贝派度酸片项目信息
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BEMA-231010D对照品来源自制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50
标示量(mg)180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%
19.862965122966432965012968652964532965950.06
29.832961972962362962160.01
单位质量响应值RSD%判断
30080.6330133.880.13数据可信
供试品溶液-2024090421批-pH4.5(内含0.45%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min129532-295329.7818.6622.609.788.6622.60
215608-156085.1705.17
323516-235167.7897.79
431088-3108810.29710.30
530679-3067910.16110.16
626439-264398.7578.76
10min174423-7442324.65019.7746.8024.6719.7946.75
266383-6638321.98722.00
369946-6994623.16723.18
43046-30461.0091.03
569632-6963223.06323.08
674785-7478524.77024.78
15min191421-9142130.28030.915.2030.3430.965.21
289488-8948829.64029.69
391188-9118830.20330.25
490059-9005929.82929.85
5102211-10221133.85433.91
695505-9550531.63331.69
20min199106-9910632.82627.1447.2532.9327.2447.13
294955-9495531.45131.55
395197-9519731.53131.63
43041-30411.0071.08
599914-9991433.09333.20
699398-9939832.92233.03
30min1111722-11172237.00436.402.9937.1736.542.98
2107311-10731135.54335.69
3104398-10439834.57834.73
4111403-11140336.89836.97
5112642-11264237.30937.48
6111862-11186237.05037.21
45min1122438-12243840.55339.852.8640.7840.062.80
2117668-11766838.97439.18
3115829-11582938.36438.58
4124591-12459141.26741.40
5122748-12274840.65640.89
6118563-11856339.27039.50
60min1125534-12553441.57941.602.1241.8741.872.09
2123681-12368140.96541.24
3121315-12131540.18140.46
4127559-12755942.25042.45
5127974-12797442.38742.68
6127518-12751842.23642.53
极限1134037-13403744.39545.071.1044.7645.411.06
2134660-13466044.60244.94
3137969-13796945.69846.04
4137203-13720345.44445.71
5136437-13643745.19045.56
6136199-13619945.11145.47
贝派度酸片项目信息
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BEMA-231010D对照品来源自制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50
标示量(mg)180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%
19.862958892959992960322959242959632959610.02
29.832960772959812960290.03
单位质量响应值RSD%判断
30016.3330114.850.24数据可信
供试品溶液-2024090421批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1110328-11032836.59336.661.9636.5936.661.96
2113961-11396137.79837.80
3109486-10948636.31436.31
4111226-11122636.89136.89
5107390-10739035.61935.62
6110701-11070136.71736.72
10min1227019-22701975.29775.301.1475.3675.361.14
2230615-23061576.48976.55
3224477-22447774.45474.51
4229119-22911975.99376.05
5223988-22398874.29174.35
6226895-22689575.25675.32
15min1261359-26135986.68686.640.9286.8786.820.92
2263490-26349087.39387.58
3258617-25861785.77785.96
4261981-26198186.89387.08
5258099-25809985.60585.79
6263770-26377087.48687.67
20min1275842-27584291.49091.480.9191.8291.810.92
2277793-27779392.13792.47
3273473-27347390.70491.03
4275989-27598991.53991.87
5272524-27252490.39090.72
6279166-27916692.59392.93
30min1287172-28717295.24895.510.7395.7396.000.73
2289846-28984696.13596.62
3287831-28783195.46795.95
4288112-28811295.56096.05
5284497-28449794.36194.84
6290375-29037596.31096.80
45min1293377-29337797.30697.760.5997.9598.410.59
2296546-29654698.35799.01
3296308-29630898.27898.92
4294782-29478297.77298.42
5292120-29212096.88997.52
6295411-29541197.98198.63
60min1296240-29624098.25698.640.5499.0699.440.54
2299317-29931799.276100.09
3299021-29902199.17899.98
4297657-29765798.72699.53
5295215-29521597.91698.71
6296918-29691898.48099.29
极限1301460-30146099.98799.890.25100.96100.860.25
2301000-30100099.834100.81
3300965-30096599.823100.79
4302245-302245100.247101.22
5300019-30001999.509100.47
6301311-30131199.938100.91
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