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)2.5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%
110.912238222237892238852239622237942238500.04
211.042233582241582237580.26
单位质量响应值RSD%判断
20517.8720267.930.87数据可信
长期6月-供试品溶液-2025041821-半片批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min194954-9495483.64883.582.7383.6583.582.73
295965-9596584.53884.54
390023-9002379.30479.30
494717-9471783.43983.44
596018-9601884.58584.58
697574-9757485.95685.96
10min1103361-10336191.05490.722.9291.1990.862.92
2103520-10352091.19491.33
397476-9747685.86986.00
4102808-10280890.56690.71
5104203-10420391.79591.94
6106542-10654293.85694.00
15min1105584-10558493.01293.002.4693.3093.292.47
2106199-10619993.55493.85
3101054-10105489.02189.30
4105206-10520692.67992.97
5106288-10628893.63293.93
6109073-10907396.08596.39
20min1106029-10602993.40494.382.9293.8594.822.92
2107888-10788895.04295.49
3101847-10184789.72090.14
4106955-10695594.22094.66
5109076-10907696.08896.54
6111021-11102197.80198.26
30min1108867-10886795.90495.883.0896.5196.483.08
2108482-10848295.56596.17
3102967-10296790.70691.28
4109154-10915496.15796.76
5110384-11038497.24097.85
6113179-11317999.703100.33
极限1110885-11088597.68297.913.0998.4498.683.09
2112222-11222298.85999.63
3104511-10451192.06792.79
4111957-11195798.62699.39
5113228-11322899.746100.52
6114081-114081100.497101.29
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)2.5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%
110.912239622248912234702233922233692238170.29
211.042240582245962243270.17
单位质量响应值RSD%判断
20514.8520319.470.68数据可信
长期6月-供试品溶液-2025041821-半片批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min195954-9595484.42784.553.0884.4384.553.08
294680-9468083.30683.31
391149-9114980.19980.20
497051-9705185.39285.39
598211-9821186.41386.41
699523-9952387.56787.57
10min1102458-10245890.15090.652.4190.2990.792.41
2102302-10230290.01290.15
398820-9882086.94987.08
4103930-10393091.44591.59
5104652-10465292.08092.22
6105980-10598093.24893.39
15min1106065-10606593.32393.232.4693.6193.522.46
2104774-10477492.18792.48
3101724-10172489.50489.78
4106134-10613493.38493.68
5107719-10771994.77995.08
6109332-10933296.19896.50
20min1107135-10713594.26594.463.0294.7194.903.02
2106094-10609493.34993.79
3101823-10182389.59190.02
4108858-10885895.78196.23
5108905-10890595.82296.28
6111308-11130897.93698.40
30min1108667-10866795.61396.282.5296.2296.892.52
2108850-10885095.77496.37
3104878-10487892.27992.86
4110209-11020996.96997.58
5110843-11084397.52798.14
6113126-11312699.536100.16
极限1112229-11222998.74797.992.5299.5198.762.51
2109850-10985096.65497.41
3106685-10668593.86994.60
4112509-11250998.99399.76
5112100-11210098.63399.41
6114871-114871101.071101.86
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