盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.722042342047812043422041262043172043600.13
215.672065582066092065840.02
单位质量响应值RSD%判断
13000.0013183.411.00数据可信
长期6月-供试品溶液-2024042521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%
5min131330-3133016.03622.0418.3616.0422.0418.36
239042-3904219.98319.98
340683-4068320.82320.82
451056-5105626.13226.13
543799-4379922.41822.42
652471-5247126.85726.86
10min1184720-18472094.54775.0814.7694.6475.2014.73
2137257-13725770.25370.36
3120292-12029261.57061.69
4145546-14554674.49674.64
5138802-13880271.04471.17
6153486-15348678.56078.71
15min1203382-203382104.099101.132.08104.71101.672.11
2198539-198539101.620102.12
3193880-19388099.23599.69
4197665-197665101.172101.73
5192086-19208698.31798.84
6199935-199935102.334102.92
20min1207358-207358106.134102.352.26107.33103.452.28
2199609-199609102.167103.23
3198416-198416101.557102.57
4196308-196308100.478101.60
5195212-19521299.917100.98
6202860-202860103.831104.99
30min1202830-202830103.816100.402.33105.60102.072.35
2197688-197688101.184102.82
3190439-19043997.47499.05
4191756-19175698.14899.83
5195832-195832100.234101.85
6198388-198388101.542103.27
45min1203584-203584104.20299.672.39106.56101.902.41
2193024-19302498.797100.99
3191766-19176698.153100.27
4191689-19168998.114100.34
5192171-19217198.360100.54
6196165-196165100.405102.70
极限1202344-202344103.56799.802.67106.51102.582.69
2193741-19374199.164101.91
3189739-18973997.11699.78
4191128-19112897.827100.60
5192475-19247598.516101.24
6200497-200497102.622105.47
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.722048812051752053842047232047042049730.15
215.672062082065222063650.11
单位质量响应值RSD%判断
13038.9913169.430.71数据可信
长期6月-供试品溶液-2024042621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%
5min144021-4402122.51019.0426.6122.5119.0426.62
223630-2363012.08312.08
347369-4736924.22224.22
442997-4299721.98621.99
539157-3915720.02220.02
626272-2627213.43413.43
10min1126905-12690564.89168.4412.1665.0268.5412.11
2162615-16261583.15183.22
3133455-13345568.24068.38
4120890-12089061.81661.94
5118557-11855760.62360.73
6140612-14061271.90071.97
15min1193275-19327598.82998.772.3399.3199.252.32
2190814-19081497.57098.10
3196282-196282100.366100.88
4187172-18717295.70896.17
5191420-19142097.88098.33
6199984-199984102.259102.73
20min1195392-19539299.911100.342.07100.95101.372.06
2191039-19103997.68598.76
3200487-200487102.516103.59
4193779-19377999.086100.08
5195055-19505599.739100.73
6201608-201608103.090104.13
30min1193821-19382199.10898.802.08100.70100.392.08
2191376-19137697.85899.47
3197408-197408100.942102.58
4187883-18788396.07197.62
5190683-19068397.50399.05
6198157-198157101.325102.94
45min1194868-19486899.64398.682.06101.78100.822.05
2191484-19148497.913100.07
3197973-197973101.231103.43
4187216-18721695.73097.81
5190495-19049597.40799.49
6195834-195834100.137102.31
极限1192199-19219998.27898.182.48100.97100.872.46
2189494-18949496.89599.60
3195336-19533699.882102.65
4187354-18735495.80198.41
5188016-18801696.13998.77
6199604-199604102.065104.80
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.722058482068852050952056302051472057210.36
215.672062982059192061080.14
单位质量响应值RSD%判断
13086.5813153.030.36数据可信
加速6月-供试品溶液-2024042521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%
5min199608-9960850.87233.2870.3450.8733.2870.34
222944-2294411.71811.72
372815-7281537.18837.19
4135595-13559569.25169.25
525143-2514312.84112.84
634903-3490317.82617.83
10min1186265-18626595.12990.2811.9695.4190.4712.02
2182132-18213293.01893.08
3189141-18914196.59896.80
4194913-19491399.54699.93
5171466-17146687.57187.64
6136743-13674369.83769.94
15min1189044-18904496.54998.421.9297.3699.101.88
2191496-19149697.80198.38
3195534-19553499.863100.61
4192935-19293598.53699.47
5188934-18893496.49297.05
6198292-198292101.272101.76
20min1189040-18904096.54698.681.7897.8999.921.82
2190267-19026797.17398.30
3196960-196960100.591101.89
4196803-196803100.511102.00
5191414-19141497.75998.85
6194857-19485799.517100.57
30min1186577-18657795.28998.432.5797.17100.222.50
2195856-195856100.028101.69
3196605-196605100.410102.27
4193136-19313698.638100.68
5186726-18672695.36597.00
6197519-197519100.877102.48
45min1183015-18301593.46997.162.4795.8899.492.45
2190853-19085397.47299.69
3193539-19353998.844101.26
4193934-19393499.046101.64
5186006-18600694.99797.16
6194097-19409799.129101.29
极限1186242-18624295.11796.842.1198.0599.712.14
2189143-18914396.59999.36
3195602-19560299.898102.86
4191796-19179697.954101.10
5184474-18447494.21596.91
6190421-19042197.25299.97
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.722057292064992075192069242069762067290.33
215.672089342094392091860.18
单位质量响应值RSD%判断
13150.7013349.461.07数据可信
加速6月-供试品溶液-2024042521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%
5min197438-9743849.27732.3382.7649.2832.3382.76
2157454-15745479.62879.63
327080-2708013.69513.69
435657-3565718.03318.03
527796-2779614.05714.06
638177-3817719.30719.31
10min1200229-200229101.26189.0710.96101.5389.2511.07
2196603-19660399.42799.87
3171010-17101086.48486.56
4154409-15440978.08878.19
5157096-15709679.44779.53
6177433-17743389.73289.84
15min1198437-198437100.35498.053.09101.1998.733.17
2198792-198792100.534101.53
3188869-18886995.51696.07
4198916-198916100.597101.13
5193562-19356297.88998.41
6184763-18476393.43994.04
20min1197382-19738299.82197.272.45101.2198.492.54
2195333-19533398.785100.34
3186772-18677294.45595.54
4194969-19496998.60099.69
5193341-19334197.77798.84
6186240-18624094.18695.31
30min1196587-19658799.41997.012.38101.3798.772.43
2192772-19277297.48999.59
3186075-18607594.10395.71
4195516-19551698.877100.52
5193636-19363697.92699.53
6186351-18635194.24295.89
45min1195543-19554398.89196.612.51101.3998.912.56
2192614-19261497.409100.05
3188397-18839795.27797.41
4194198-19419898.211100.40
5192888-19288897.54899.70
6182588-18258892.33994.51
极限1198483-198483100.37896.813.44103.4399.653.46
2193084-19308497.647100.83
3185366-18536693.74496.41
4191507-19150796.85099.59
5197909-197909100.087102.78
6182233-18223392.16094.84
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