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%
110.912261712266062264272266052268542265330.12
211.042264862261842263350.10
单位质量响应值RSD%判断
20763.7920501.360.90数据可信
加速6月-供试品溶液-2025041521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%
5min1196538-19653885.56385.311.2085.5685.311.20
2198566-19856686.44586.45
3198437-19843786.38986.39
4192604-19260483.85083.85
5195143-19514384.95584.96
6194415-19441584.63884.64
10min1212564-21256492.53992.001.3792.6892.141.37
2212130-21213092.35092.49
3214672-21467293.45793.60
4206289-20628989.80889.95
5212335-21233592.44092.58
6209916-20991691.38791.53
15min1216406-21640694.21293.591.4694.5193.891.46
2216034-21603494.05094.35
3218860-21886095.28095.58
4209478-20947891.19691.49
5215057-21505793.62593.92
6214090-21409093.20493.50
20min1217896-21789694.86194.871.7095.3195.321.70
2218359-21835995.06295.52
3221787-22178796.55597.01
4212080-21208092.32992.77
5221672-22167296.50596.96
6215662-21566293.88894.34
30min1221218-22121896.30795.801.4996.9296.411.49
2221635-22163596.48897.10
3224333-22433397.66398.28
4214596-21459693.42494.02
5219338-21933895.48896.10
6219174-21917495.41796.02
极限1225022-22502297.96397.741.5798.7498.511.56
2225669-22566998.24599.02
3229233-22923399.796100.58
4218414-21841495.08695.84
5223926-22392697.48698.26
6224814-22481497.87298.64
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%
110.912262292264492268142269172261442265110.16
211.042264602259132261860.18
单位质量响应值RSD%判断
20761.7820487.860.94数据可信
加速6月-供试品溶液-2025041621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%
5min1194434-19443484.67983.681.3984.6883.681.39
2190765-19076583.08183.08
3187613-18761381.70881.71
4194763-19476384.82284.82
5192156-19215683.68783.69
6193108-19310884.10184.10
10min1210994-21099491.89190.541.6992.0390.681.69
2207298-20729890.28190.42
3202604-20260488.23788.37
4210281-21028191.58091.72
5205116-20511689.33189.47
6211040-21104091.91192.05
15min1214496-21449693.41692.391.5693.7192.681.55
2210342-21034291.60791.90
3207830-20783090.51390.80
4214904-21490493.59493.89
5209550-20955091.26291.55
6215657-21565793.92294.21
20min1217591-21759194.76493.471.4795.2193.911.47
2213615-21361593.03293.47
3209898-20989891.41391.85
4216664-21666494.36094.81
5212445-21244592.52392.96
6217500-21750094.72495.17
30min1220375-22037595.97694.841.3696.5895.441.36
2216822-21682294.42995.03
3213330-21333092.90893.49
4219756-21975695.70796.31
5215680-21568093.93294.53
6220597-22059796.07396.68
极限1224357-22435797.71196.541.3998.4897.301.39
2220908-22090896.20996.96
3217717-21771794.81995.56
4223620-22362097.39098.16
5218590-21859095.19995.95
6224850-22485097.92598.69
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%
110.912254492257902258852246492257982255140.23
211.042247032253492250260.21
单位质量响应值RSD%判断
20670.3920382.791.00数据可信
加速6月-供试品溶液-2025041821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%
5min1203921-20392189.23689.661.8889.2489.661.89
2198498-19849886.86386.86
3205310-20531089.84489.84
4210417-21041792.07992.08
5206158-20615890.21590.21
6204981-20498189.70089.70
10min1216056-21605694.54694.501.3594.6994.651.34
2211477-21147792.54292.69
3215268-21526894.20194.35
4220561-22056196.51896.67
5216031-21603194.53594.69
6216282-21628294.64594.79
15min1220128-22012896.32896.281.2996.6396.591.29
2215352-21535294.23894.54
3219903-21990396.23096.54
4224185-22418598.10398.42
5220933-22093396.68096.99
6219670-21967096.12896.43
20min1222124-22212497.20297.341.1697.6797.801.16
2217799-21779995.30995.76
3222685-22268597.44797.91
4225602-22560298.72399.20
5223153-22315397.65298.12
6223247-22324797.69398.16
30min1226351-22635199.05198.781.2899.6899.411.27
2220660-22066096.56197.18
3225232-22523298.56299.19
4229480-229480100.420101.06
5226069-22606998.92899.56
6226564-22656499.14499.77
极限1229578-229578100.463100.311.21101.26101.101.21
2223973-22397398.01198.79
3229737-229737100.533101.33
4232193-232193101.608102.42
5229738-229738100.533101.33
6230127-230127100.704101.50
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%
110.912248922256622255972247092251452252010.19
211.042249062257812253440.28
单位质量响应值RSD%判断
20641.7020411.590.80数据可信
中间条件6月-供试品溶液-2025041521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%
5min1196388-19638885.93886.571.3085.9486.571.30
2201912-20191288.35588.35
3194954-19495485.31085.31
4199923-19992387.48587.48
5196787-19678786.11286.11
6197091-19709186.24586.25
10min1211168-21116892.40592.141.3192.5592.291.31
2215610-21561094.34994.50
3207976-20797691.00891.15
4210736-21073692.21692.36
5208605-20860591.28491.43
6209325-20932591.59991.74
15min1215792-21579294.42994.151.5894.7394.451.59
2221334-22133496.85497.16
3212526-21252693.00093.29
4215804-21580494.43494.73
5212981-21298193.19993.49
6212489-21248992.98393.28
20min1219011-21901195.83795.651.4596.2996.101.45
2224336-22433698.16798.63
3216131-21613194.57795.03
4219326-21932695.97596.43
5216070-21607094.55095.00
6216602-21660294.78395.23
30min1221975-22197597.13497.391.3597.7598.001.35
2228364-22836499.930100.56
3220164-22016496.34296.95
4222769-22276997.48298.10
5221379-22137996.87497.48
6220653-22065396.55697.17
极限1225917-22591798.85998.981.4299.6499.751.42
2231988-231988101.516102.31
3223172-22317297.65898.43
4226971-22697199.321100.10
5223457-22345797.78398.55
6225584-22558498.71499.48
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%
110.912252082246862255942252192259842253380.22
211.042246582255452251020.28
单位质量响应值RSD%判断
20654.2620389.670.92数据可信
中间条件6月-供试品溶液-2025041621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%
5min1196132-19613285.84685.871.4685.8585.871.46
2195674-19567485.64685.65
3191503-19150383.82083.82
4195563-19556385.59785.60
5198433-19843386.85386.85
6199793-19979387.44887.45
10min1208884-20888491.42891.511.5691.5791.661.56
2209564-20956491.72591.87
3203730-20373089.17289.31
4208121-20812191.09491.24
5210492-21049292.13192.28
6213681-21368193.52793.67
15min1214766-21476694.00293.561.6894.3093.861.68
2214198-21419893.75494.05
3207689-20768990.90591.19
4212116-21211692.84293.14
5215567-21556794.35394.65
6218200-21820095.50595.81
20min1217959-21795995.40094.931.4295.8595.381.41
2218586-21858695.67496.13
3212100-21210092.83593.28
4214769-21476994.00394.45
5217149-21714995.04595.50
6220801-22080196.64497.10
30min1221295-22129596.86096.421.0697.4797.031.06
2221961-22196197.15197.76
3216180-21618094.62195.22
4219473-21947396.06296.67
5220216-22021696.38897.00
6222632-22263297.44598.07
极限1224831-22483198.40898.081.1399.1898.851.12
2227306-22730699.491100.26
3219941-21994196.26797.02
4223392-22339297.77898.54
5223393-22339397.77898.55
6225647-22564798.76599.55
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