熊去氧胆酸口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号C092A240304对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
113.585338953609536395385753510536010.33
213.605329652986531410.42
单位质量响应值RSD%判断
3947.053907.430.72数据可信
供试品溶液-25052101批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138476-3847670.54280.706.6670.5480.706.66
243311-4331179.40679.41
346287-4628784.86284.86
444573-4457381.72081.72
546157-4615784.62484.62
645282-4528283.02083.02
10min143078-4307878.97982.612.7979.7683.512.83
244385-4438581.37582.26
346418-4641885.10386.05
444655-4465581.87082.78
545727-4572783.83684.78
646086-4608684.49485.42
15min144066-4406680.79084.132.6782.4585.942.71
245365-4536583.17284.96
347514-4751487.11289.00
445401-4540183.23885.06
546869-4686985.92987.80
646110-4611084.53886.40
20min144314-4431481.24585.072.9083.8087.822.92
246025-4602584.38287.09
348344-4834488.63491.49
446151-4615184.61387.36
547220-4722086.57389.40
646338-4633884.95687.76
30min145207-4520782.88286.993.2486.3490.693.25
246495-4649585.24488.89
349577-4957790.89494.74
447792-4779287.62291.30
548490-4849088.90192.69
647140-4714086.42690.17
45min145978-4597884.29688.513.7088.6893.173.67
246864-4686485.92090.52
350812-5081293.15898.01
448905-4890589.66294.32
549455-4945590.67195.45
647640-4764087.34392.05
极限145804-4580483.97789.354.1789.3094.994.12
246896-4689685.97991.53
350871-5087193.26799.15
449648-4964891.02496.68
550529-5052992.64098.42
648649-4864989.19394.87
熊去氧胆酸口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号C092A240304对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
113.585346153816537055370753559536500.27
213.605308553478532820.53
单位质量响应值RSD%判断
3950.663917.790.60数据可信
供试品溶液-25052301批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142563-4256377.89687.168.6077.9087.168.60
244182-4418280.85980.86
345892-4589283.98883.99
452086-5208695.32495.32
552347-5234795.80195.80
648677-4867789.08589.08
10min147235-4723586.44689.352.6987.3190.322.73
249267-4926790.16591.06
347146-4714686.28387.22
449735-4973591.02192.08
550233-5023391.93393.00
649327-4932790.27591.26
15min148050-4805087.93790.472.7389.7692.432.76
249974-4997491.45993.36
347431-4743186.80588.70
450616-5061692.63494.70
550455-5045592.33994.42
650081-5008191.65493.65
20min147796-4779687.47391.483.6190.2894.443.62
250186-5018691.84794.76
347717-4771787.32890.18
451262-5126293.81696.92
551783-5178394.76997.88
651164-5116493.63696.65
30min147967-4796787.78693.333.9591.5697.323.95
251137-5113793.58797.52
349162-4916289.97393.80
452607-5260796.277100.42
552846-5284696.715100.88
652271-5227195.66299.71
45min149814-4981491.16695.173.6195.92100.203.63
251834-5183494.86399.84
349779-4977991.10295.93
453209-5320997.379102.59
554265-5426599.312104.55
653125-5312597.225102.34
极限149810-4981091.15896.153.9596.92102.233.95
252459-5245996.006102.04
350313-5031392.07997.92
453979-5397998.788105.08
554879-54879100.435106.78
653793-5379398.448104.64
熊去氧胆酸口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号C092A240304对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
113.585354753607536575349653419535450.18
213.605294953033529910.12
单位质量响应值RSD%判断
3942.933896.400.84数据可信
供试品溶液-25052302批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143435-4343579.78890.515.8579.7990.515.85
250772-5077293.26693.27
349886-4988691.63891.64
450725-5072593.18093.18
550532-5053292.82592.83
650283-5028392.36892.37
10min148374-4837488.86193.352.4089.7594.362.44
251040-5104093.75894.79
351147-5114793.95594.97
451710-5171094.98996.02
551336-5133694.30295.33
651309-5130994.25295.28
15min148349-4834988.81594.623.1690.6996.663.18
251528-5152894.65596.73
351700-5170094.97197.03
452924-5292497.21999.31
552368-5236896.19898.28
652190-5219095.87197.94
20min148900-4890089.82795.402.9492.6998.502.97
252129-5212995.75998.89
352192-5219295.87498.99
452944-5294497.256100.43
552901-5290197.177100.32
652547-5254796.52799.67
30min149748-4974891.38597.042.9695.24101.202.99
252878-5287897.135101.33
353210-5321097.744101.93
454126-5412699.427103.68
553494-5349498.266102.49
653505-5350598.286102.50
45min150343-5034392.47898.443.1797.35103.673.18
253353-5335398.007103.28
353708-5370898.659103.93
454912-54912100.871106.23
554614-54614100.324105.64
654587-54587100.274105.58
极限150608-5060892.96599.043.1898.87105.363.19
253783-5378398.797105.16
354324-5432499.791106.16
455459-55459101.876108.35
554509-54509100.131106.57
654796-54796100.658107.08
熊去氧胆酸口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号C092A240304对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
113.585365154057538815391454067539140.32
213.605408854169541280.11
单位质量响应值RSD%判断
3970.103980.000.18数据可信
供试品溶液-25052302批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154682-5468299.04695.813.3699.0595.813.36
254467-5446798.65698.66
349984-4998490.53690.54
452337-5233794.79894.80
552156-5215694.47094.47
653752-5375297.36197.36
10min150718-5071891.86696.604.4092.9797.664.34
255920-55920101.288102.38
356013-56013101.456102.46
450955-5095592.29593.35
553929-5392997.68298.73
652443-5244394.99096.07
15min156435-56435102.22198.603.66104.34100.743.60
256749-56749102.789105.01
351561-5156193.39295.53
454547-5454798.801100.88
554348-5434898.441100.58
652966-5296695.93798.07
20min156461-56461102.26898.703.61105.52101.943.55
256713-56713102.724106.09
351505-5150593.29196.46
454740-5474099.151102.33
554241-5424198.247101.48
653292-5329296.52899.73
30min157187-57187103.58399.124.03107.98103.453.95
257077-57077103.384107.89
351501-5150193.28497.49
454808-5480899.274103.55
554519-5451998.750103.07
653250-5325096.452100.73
45min156975-56975103.19998.704.24108.74104.134.14
256964-56964103.179108.83
351619-5161993.49798.74
454828-5482899.310104.69
554506-5450698.727104.14
652059-5205994.29499.64
极限156657-56657102.62398.733.97109.31105.263.90
257100-57100103.425110.23
351202-5120292.74299.03
454322-5432298.393104.88
554257-5425798.276104.79
653495-5349596.895103.29
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