盐酸奥洛他定片项目信息
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%
110.982248212248822252192252852261072252630.23
211.082255442257932256680.08
单位质量响应值RSD%判断
20515.7620367.150.52数据可信
供试品溶液-24111801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%
5min1256963-256963112.91197.949.08112.9197.949.08
2204708-20470889.95089.95
3207511-20751191.18291.18
4214548-21454894.27494.27
5237284-237284104.264104.26
6216390-21639095.08395.08
10min1285602-285602125.496107.519.89125.68107.679.89
2224752-22475298.75898.91
3228562-228562100.432100.58
4236073-236073103.732103.89
5262544-262544115.364115.54
6230450-230450101.261101.42
15min1289862-289862127.367108.8510.01127.76109.1910.00
2227534-22753499.980100.29
3231174-231174101.579101.90
4239197-239197105.105105.43
5265622-265622116.716117.08
6232916-232916102.345102.67
20min1289126-289126127.044109.049.90127.65109.569.89
2226888-22688899.696100.18
3232300-232300102.074102.56
4241386-241386106.067106.57
5266627-266627117.158117.72
6232585-232585102.199102.70
30min1290190-290190127.512108.9610.03128.33109.6710.03
2226553-22655399.549100.20
3231700-231700101.811102.47
4241087-241087105.935106.62
5265490-265490116.658117.41
6232818-232818102.302102.97
45min1290431-290431127.617109.1810.02128.65110.0710.01
2227857-227857100.122100.94
3231889-231889101.894102.72
4240752-240752105.788106.65
5266827-266827117.246118.20
6233068-233068102.412103.25
60min1288577-288577126.803108.859.78128.05109.929.78
2227421-22742199.930100.91
3232201-232201102.031103.03
4239956-239956105.438106.47
5265584-265584116.699117.85
6232583-232583102.199103.21
极限1289133-289133127.047108.7110.00128.51109.9610.00
2226460-22646099.508100.65
3231361-231361101.662102.83
4239791-239791105.366106.58
5265548-265548116.684118.02
6232099-232099101.986103.17
盐酸奥洛他定片项目信息
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%
110.982266112262782257802254492260822260400.20
211.082261682257552259620.13
单位质量响应值RSD%判断
20586.5220393.680.67数据可信
供试品溶液-24111901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%
5min1227386-22738699.67996.195.5499.6896.195.54
2227600-22760099.77299.77
3214210-21421093.90393.90
4200892-20089288.06588.06
5213097-21309793.41593.41
6233415-233415102.322102.32
10min1249929-249929109.561105.755.74109.73105.915.73
2249174-249174109.230109.40
3234144-234144102.641102.80
4221302-22130297.01297.16
5233845-233845102.510102.67
6258970-258970113.524113.69
15min1251831-251831110.395107.055.77110.74107.385.76
2254318-254318111.485111.83
3237055-237055103.917104.24
4223345-22334597.90798.22
5237265-237265104.009104.34
6261376-261376114.579114.94
20min1251317-251317110.169106.875.81110.70107.385.81
2252812-252812110.825111.36
3235983-235983103.447103.95
4223176-22317697.83398.30
5237377-237377104.058104.56
6262081-262081114.888115.44
30min1251895-251895110.423106.966.10111.14107.666.10
2254678-254678111.643112.36
3236412-236412103.635104.31
4222054-22205497.34197.98
5236647-236647103.738104.41
6262321-262321114.993115.74
45min1251585-251585110.287106.985.87111.19107.865.87
2253321-253321111.048111.95
3238095-238095104.373105.22
4222705-22270597.62798.42
5236326-236326103.598104.44
6262284-262284114.977115.91
60min1249338-249338109.302106.706.08110.39107.756.08
2250328-250328109.736110.83
3236967-236967103.879104.90
4222057-22205797.34398.30
5236699-236699103.761104.78
6265035-265035116.183117.31
极限1249898-249898109.547106.755.88110.81107.985.88
2251426-251426110.217111.49
3239897-239897105.163106.36
4221405-22140597.05798.18
5235978-235978103.445104.64
6262562-262562115.099116.42
盐酸奥洛他定片项目信息
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%
110.982256662248462260032258422260862256890.23
211.082252132250852251490.05
单位质量响应值RSD%判断
20554.5520320.310.82数据可信
供试品溶液-1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%
5min1207731-20773191.29895.023.9991.3095.023.99
2203106-20310689.26689.27
3219937-21993796.66396.66
4223705-22370598.31998.32
5219688-21968896.55396.55
6222969-22296997.99598.00
10min1230839-230839101.454106.825.24101.61106.985.24
2223506-22350698.23198.38
3250830-250830110.240110.40
4251100-251100110.359110.52
5247375-247375108.722108.88
6254661-254661111.924112.09
15min1237589-237589104.421109.155.18104.74109.495.18
2227854-227854100.142100.45
3254471-254471111.841112.19
4256935-256935112.923113.27
5252168-252168110.828111.17
6261116-261116114.761115.11
20min1238566-238566104.850109.955.23105.35110.465.22
2229644-229644100.929101.41
3257042-257042112.971113.50
4260400-260400114.446114.98
5253581-253581111.449111.98
6261728-261728115.030115.57
30min1238700-238700104.909109.955.35105.58110.655.34
2228981-228981100.638101.29
3257023-257023112.962113.68
4260068-260068114.300115.03
5253559-253559111.440112.15
6262656-262656115.438116.17
45min1238199-238199104.689109.945.26105.53110.825.26
2229764-229764100.982101.80
3257945-257945113.367114.28
4259396-259396114.005114.92
5253073-253073111.226112.12
6262439-262439115.343116.27
60min1238616-238616104.872109.705.31105.89110.775.31
2228184-228184100.287101.27
3257538-257538113.189114.29
4258761-258761113.726114.83
5253232-253232111.296112.38
6261305-261305114.844115.96
极限1238283-238283104.726109.685.35105.92110.945.35
2228132-228132100.265101.42
3257095-257095112.994114.28
4259544-259544114.070115.37
5253123-253123111.248112.52
6261209-261209114.802116.11
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