盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.942278692280292282792282032278232280410.09
210.972279072285622282340.21
单位质量响应值RSD%判断
20844.7020805.290.14数据可信
供试品溶液-25021801批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1202239-20223987.22886.132.9887.2386.132.98
2198621-19862185.66785.67
3199008-19900885.83485.83
4206565-20656589.09389.09
5189097-18909781.55981.56
6202648-20264887.40487.40
10min1213588-21358892.12291.761.4392.2791.901.44
2211195-21119591.09091.23
3210163-21016390.64590.79
4217196-21719693.67993.83
5209355-20935590.29790.43
6215006-21500692.73492.88
15min1218202-21820294.11293.761.4294.4194.061.42
2215743-21574393.05293.35
3215260-21526092.84493.14
4221829-22182995.67795.98
5213622-21362292.13792.42
6219685-21968594.75295.05
20min1222162-22216295.82095.111.7596.2895.561.75
2218705-21870594.32994.78
3217803-21780393.94094.39
4226402-22640297.64998.11
5215739-21573993.05093.49
6222296-22229695.87896.34
30min1225768-22576897.37696.641.4997.9997.251.49
2221919-22191995.71696.32
3221356-22135695.47396.08
4228781-22878198.67599.30
5220369-22036995.04795.64
6226195-22619597.56098.18
极限1229390-22939098.93898.511.5999.7299.291.60
2226342-22634297.62398.39
3225418-22541897.22597.99
4233624-233624100.764101.56
5224386-22438696.78097.53
6231290-23129099.757100.54
盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.942280042284642281542278722280112281010.10
210.972285482284662285070.03
单位质量响应值RSD%判断
20850.1820830.170.07数据可信
供试品溶液-25021801批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1217147-21714793.58993.011.4393.5993.011.43
2217747-21774793.84893.85
3219691-21969194.68694.69
4215172-21517292.73892.74
5211020-21102090.94890.95
6214000-21400092.23392.23
10min1230285-23028599.252100.251.9699.41100.411.95
2229686-22968698.99399.15
3232376-232376100.153100.31
4228522-22852298.49298.65
5233702-233702100.724100.88
6241037-241037103.886104.04
15min1229727-22972799.011100.562.0599.33100.882.05
2231423-23142399.742100.06
3232319-232319100.128100.45
4229147-22914798.76199.08
5235255-235255101.394101.71
6242007-242007104.304104.63
20min1230472-23047299.332100.582.0299.82101.072.01
2231298-23129899.688100.18
3232257-232257100.101100.59
4228886-22888698.64999.13
5235422-235422101.466101.95
6241867-241867104.243104.74
30min1231685-23168599.855100.691.90100.51101.341.90
2231725-23172599.872100.53
3232554-232554100.229100.89
4229087-22908798.73599.38
5234781-234781101.189101.85
6241849-241849104.236104.91
极限1230776-23077699.463100.502.06100.28101.322.05
2230775-23077599.463100.28
3232144-232144100.053100.88
4228651-22865198.54799.36
5234628-234628101.123101.95
6242080-242080104.335105.18
盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.942286442285232281792285792282772284400.09
210.972269862270952270400.04
单位质量响应值RSD%判断
20881.1720696.440.63数据可信
供试品溶液-25021801批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1186227-18622780.46378.392.2580.4678.382.26
2186560-18656080.60780.61
3180339-18033977.91977.92
4177664-17766476.76376.76
5177229-17722976.57576.57
6180504-18050477.99077.99
10min1205263-20526388.68886.501.7088.8286.631.70
2203097-20309787.75287.89
3198478-19847885.75685.89
4196082-19608284.72184.85
5198298-19829885.67885.81
6199970-19997086.40186.53
15min1215221-21522192.99090.012.0193.2790.282.01
2211124-21112491.22091.50
3205433-20543388.76189.03
4203872-20387288.08788.36
5207812-20781289.78990.06
6206466-20646689.20789.48
20min1217186-21718693.83991.781.6294.2892.211.63
2216090-21609093.36693.80
3210503-21050390.95291.37
4208444-20844490.06290.48
5211583-21158391.41891.84
6210756-21075691.06191.48
30min1223371-22337196.51194.081.6497.1094.651.64
2220389-22038995.22395.81
3215886-21588693.27793.85
4213417-21341792.21192.78
5216754-21675493.65294.22
6216602-21660293.58794.16
极限1227178-22717898.15696.691.5698.9197.421.56
2228771-22877198.84599.59
3221428-22142895.67296.40
4219761-21976194.95295.67
5222911-22291196.31397.04
6222602-22260296.17996.91
盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.942263462266872263222260092262252263180.11
210.972258922259462259190.02
单位质量响应值RSD%判断
20687.2020594.260.32数据可信
供试品溶液-25021801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%
5min1233730-233730101.710101.561.41101.71101.561.41
2235186-235186102.344102.34
3236292-236292102.825102.83
4236172-236172102.773102.77
5228216-22821699.31199.31
6230715-230715100.398100.40
10min1237226-237226103.232102.860.99103.40103.030.99
2236365-236365102.857103.03
3238098-238098103.611103.78
4239060-239060104.030104.20
5234939-234939102.236102.40
6232607-232607101.222101.39
15min1237417-237417103.315102.861.04103.66103.201.04
2236507-236507102.919103.26
3239282-239282104.126104.47
4237444-237444103.326103.67
5235409-235409102.441102.78
6232105-232105101.003101.34
20min1237556-237556103.375102.690.80103.89103.200.80
2235828-235828102.623103.14
3237292-237292103.260103.78
4237473-237473103.339103.86
5234913-234913102.225102.73
6232791-232791101.302101.81
30min1238710-238710103.877102.541.12104.56103.221.11
2235501-235501102.481103.17
3236712-236712103.008103.70
4237472-237472103.339104.03
5233863-233863101.768102.45
6231496-231496100.738101.41
极限1240108-240108104.486102.411.29105.34103.261.28
2234667-234667102.118102.97
3236010-236010102.702103.56
4236483-236483102.908103.77
5233655-233655101.678102.52
6231145-231145100.585101.43
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