氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.191781281781501787331788221790221785710.23
214.301786921783971785440.12
单位质量响应值RSD%判断
12584.2812485.590.56数据可信
供试品溶液-6087549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%
2min145667-4566725.76926.9216.4325.7726.9216.42
246305-4630526.12926.13
334363-3436319.39119.39
456396-5639631.82431.82
554438-5443830.71930.72
649038-4903827.67227.67
5min180662-8066245.51755.3015.7145.5255.3015.71
277296-7729643.61743.62
3100371-10037156.63856.64
4109555-10955561.82161.82
5113621-11362164.11564.12
6106491-10649160.09260.09
10min1125780-12578070.97672.271.3270.9872.271.32
2127142-12714271.74571.74
3130376-13037673.57073.57
4129635-12963573.15273.15
5127497-12749771.94571.95
6127968-12796872.21172.21
15min1130650-13065073.72471.405.3173.7271.405.31
2128216-12821672.35172.35
3131621-13162174.27274.27
4114754-11475464.75464.75
5122483-12248369.11669.12
6131435-13143574.16774.17
20min1137358-13735877.51076.082.0377.5176.082.04
2130189-13018973.46473.46
3137258-13725877.45377.45
4133181-13318175.15375.15
5135558-13555876.49476.49
6135422-13542276.41776.42
30min1135661-13566176.55278.392.8676.5578.392.85
2137863-13786377.79577.79
3136912-13691277.25877.26
4142234-14223480.26180.26
5145287-14528781.98481.98
6135578-13557876.50576.51
45min1132766-13276674.91880.926.2274.9280.926.22
2131102-13110273.97973.98
3149663-14966384.45384.45
4149106-14910684.13984.14
5148656-14865683.88583.88
6149162-14916284.17084.17
60min1148723-14872383.92383.721.3383.9283.731.33
2146743-14674382.80582.81
3148568-14856883.83583.84
4149720-14972084.48584.49
5145526-14552682.11982.12
6150948-15094885.17885.18
90min1140205-14020579.11683.743.9479.1283.743.94
2145560-14556082.13882.14
3154617-15461787.24987.25
4153777-15377786.77586.77
5151870-15187085.69985.70
6144396-14439681.48181.48
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1141163-14116379.65783.723.0979.6683.723.09
2144236-14423681.39181.39
3151054-15105485.23885.24
4150821-15082185.10785.11
5150147-15014784.72684.73
6152795-15279586.22186.22
极限1146345-14634582.58182.203.6782.5882.203.67
2148352-14835283.71383.71
3150466-15046684.90684.91
4148380-14838083.72983.73
5145012-14501281.82981.83
6135474-13547476.44676.45
氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.191794941795551794001794711791921794220.08
214.301791671790731791200.04
单位质量响应值RSD%判断
12644.2612525.870.67数据可信
供试品溶液-6087549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%
2min171285-7128540.06538.8311.3540.0738.8411.35
262461-6246135.10635.11
357034-5703432.05632.06
470917-7091739.85939.86
575386-7538642.37042.37
677472-7747243.54343.54
5min1110770-11077062.25860.358.4962.2660.358.49
2108705-10870561.09761.10
389145-8914550.10450.10
4111971-11197162.93362.93
5109743-10974361.68161.68
6113889-11388964.01164.01
10min1129373-12937372.71370.888.0872.7170.888.08
2128010-12801071.94771.95
3106217-10621759.69959.70
4135462-13546276.13676.14
5130567-13056773.38573.38
6127041-12704171.40371.40
15min1129687-12968772.89076.322.8872.8976.322.88
2138502-13850277.84477.84
3132364-13236474.39574.39
4138194-13819477.67177.67
5136448-13644876.69076.69
6139500-13950078.40578.41
20min1140180-14018078.78879.614.8078.7979.614.80
2138729-13872977.97277.97
3130175-13017573.16473.16
4147279-14727982.77782.78
5145277-14527781.65281.65
6148257-14825783.32783.33
30min1154687-15468786.94181.707.0886.9481.707.08
2148499-14849983.46383.46
3150364-15036484.51184.51
4149206-14920683.86183.86
5143781-14378180.81180.81
6125620-12562070.60470.60
45min1151476-15147685.13684.822.1685.1484.822.16
2145420-14542081.73381.73
3150761-15076184.73584.73
4150236-15023684.43984.44
5155411-15541187.34887.35
6152165-15216585.52485.52
60min1156716-15671688.08186.172.9588.0886.172.95
2150554-15055484.61884.62
3150147-15014784.38984.39
4157455-15745588.49788.50
5157700-15770088.63588.63
6147304-14730482.79282.79
90min1142508-14250880.09683.454.5680.1083.454.56
2144592-14459281.26781.27
3140334-14033478.87478.87
4152723-15272385.83785.84
5155330-15533087.30287.30
6155345-15534587.31187.31
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1155343-15534387.31084.747.4987.3184.747.49
2153176-15317686.09286.09
3153913-15391386.50686.51
4158499-15849989.08489.08
5155698-15569887.50987.51
6128039-12803971.96471.96
极限1151947-15194785.40185.201.1785.4085.201.17
2151307-15130785.04185.04
3149701-14970184.13984.14
4151329-15132985.05485.05
5154803-15480387.00687.01
6150414-15041484.53984.54
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