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%
110.882246612249762262122260192256562255050.30
210.922226302228842227570.09
单位质量响应值RSD%判断
20726.5620398.991.13数据可信
供试品溶液-25022001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%
5min1198406-19840686.67185.940.7286.6785.940.72
2197079-19707986.09186.09
3195433-19543385.37285.37
4198249-19824986.60286.60
5195186-19518685.26485.26
6195991-19599185.61685.62
10min1212145-21214592.67391.831.0292.8291.971.02
2208863-20886391.23991.38
3207964-20796490.84690.99
4213342-21334293.19693.34
5210188-21018891.81891.96
6208750-20875091.19091.33
15min1216693-21669394.65994.050.7494.9694.350.74
2214230-21423093.58393.88
3213069-21306993.07693.37
4217175-21717594.87095.17
5215954-21595494.33794.63
6214666-21466693.77494.07
20min1220160-22016096.17495.720.8696.6396.170.86
2217455-21745594.99295.44
3216466-21646694.56095.01
4221629-22162996.81697.27
5219843-21984396.03596.49
6219198-21919895.75496.20
30min1224656-22465698.13897.610.9598.7598.220.95
2221524-22152496.77097.38
3220706-22070696.41297.02
4225847-22584798.65899.28
5225234-22523498.39099.00
6222697-22269797.28297.89
极限1229615-229615100.30499.720.74101.08100.490.73
2225318-22531898.42799.20
3227802-22780299.512100.28
4230003-230003100.474101.26
5228697-22869799.903100.68
6228204-22820499.688100.46
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%
110.882227682228902224012224512224262225870.11
210.922233242232052232640.04
单位质量响应值RSD%判断
20458.3620445.420.05数据可信
供试品溶液-25022001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%
5min1218587-21858795.99894.742.6996.0094.742.69
2219432-21943296.36996.37
3213333-21333393.69193.69
4218729-21872996.06196.06
5219338-21933896.32896.33
6204868-20486889.97389.97
10min1230443-230443101.205101.561.74101.37101.721.74
2235181-235181103.286103.45
3229392-229392100.744100.90
4233445-233445102.524102.68
5234559-234559103.013103.17
6224508-22450898.59998.75
15min1231889-231889101.840101.991.67102.17102.321.67
2236089-236089103.685104.02
3228871-228871100.515100.84
4235106-235106103.253103.58
5234953-234953103.186103.52
6226492-22649299.47099.78
20min1234354-234354102.923102.271.74103.42102.761.75
2236353-236353103.801104.31
3229207-229207100.662101.15
4235301-235301103.339103.84
5235491-235491103.422103.93
6226432-22643299.44499.92
30min1231840-231840101.819102.241.71102.49102.911.71
2236566-236566103.894104.57
3229691-229691100.875101.53
4235550-235550103.448104.12
5236255-236255103.758104.43
6226935-22693599.665100.31
极限1230998-230998101.449101.931.72102.29102.771.72
2236206-236206103.736104.59
3228289-228289100.259101.09
4234642-234642103.049103.90
5235587-235587103.464104.31
6226839-22683999.622100.43
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%
110.882225162224182225452228152229222226430.10
210.922228522229062228790.02
单位质量响应值RSD%判断
20463.5120410.160.19数据可信
供试品溶液-25022001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%
5min1185777-18577781.64980.431.5281.6580.431.52
2184214-18421480.96280.96
3181386-18138679.71979.72
4181428-18142879.73879.74
5186041-18604181.76581.77
6179126-17912678.72678.73
10min1202199-20219988.86788.401.4089.0088.531.40
2202267-20226788.89789.03
3199012-19901287.46687.60
4199888-19988887.85187.98
5205607-20560790.36590.50
6197860-19786086.96087.09
15min1210509-21050992.51991.731.3892.8092.011.38
2210214-21021492.38992.67
3206641-20664190.81991.10
4207152-20715291.04491.32
5212694-21269493.47993.77
6205062-20506290.12590.40
20min1215916-21591694.89593.741.5195.3394.171.51
2214901-21490194.44994.89
3210758-21075892.62893.06
4211598-21159892.99893.43
5217308-21730895.50795.95
6209218-20921891.95292.38
30min1221729-22172997.45096.101.4698.0596.691.46
2219813-21981396.60897.20
3217886-21788695.76196.35
4215942-21594294.90795.49
5222268-22226897.68798.29
6214293-21429394.18294.76
极限1225580-22558099.14398.771.4299.9099.521.43
2226872-22687299.711100.47
3222163-22216397.64198.38
4225918-22591899.291100.04
5228218-228218100.302101.07
6219697-21969796.55797.29
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%
110.882233222229612230182232152232862231600.08
210.922235972232092234030.13
单位质量响应值RSD%判断
20511.0320458.150.19数据可信
供试品溶液-25022001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%
5min1240026-240026105.246102.641.83105.25102.641.83
2233461-233461102.367102.37
3230329-230329100.994100.99
4228485-228485100.185100.19
5237000-237000103.919103.92
6235240-235240103.147103.15
10min1240785-240785105.579104.151.95105.75104.321.95
2233952-233952102.582102.75
3230896-230896101.243101.41
4238519-238519104.585104.75
5243740-243740106.874107.05
6237210-237210104.011104.18
15min1240731-240731105.555103.981.89105.91104.321.89
2233285-233285102.290102.63
3230855-230855101.225101.56
4238678-238678104.655105.00
5242630-242630106.388106.74
6236595-236595103.741104.09
20min1239915-239915105.197103.951.87105.72104.471.87
2233107-233107102.212102.72
3230612-230612101.118101.62
4238240-238240104.463104.98
5242586-242586106.368106.90
6237994-237994104.355104.87
30min1239749-239749105.124103.601.75105.83104.291.75
2232336-232336101.874102.56
3231171-231171101.363102.04
4237749-237749104.247104.94
5241524-241524105.903106.61
6235108-235108103.089103.78
极限1239077-239077104.830103.701.68105.71104.561.68
2232000-232000101.727102.58
3231457-231457101.488102.33
4236951-236951103.897104.76
5241284-241284105.797106.68
6238230-238230104.458105.32
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