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)0
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%
110.782238432236262236612242372238782238490.11
210.712252792252132252460.03
单位质量响应值RSD%判断
20765.2121031.370.91数据可信
中间条件12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%
5min1103630-10363089.08386.511.7289.0886.511.72
2100214-10021486.14786.15
3101116-10111686.92286.92
499171-9917185.25085.25
598812-9881284.94184.94
6100852-10085286.69586.70
10min1110182-11018294.71591.662.5394.8691.812.53
2106867-10686791.86692.01
3107638-10763892.52892.67
4105540-10554090.72590.87
5102073-10207387.74587.89
6107478-10747892.39192.54
15min1112867-11286797.02393.652.6697.3393.952.66
2108742-10874293.47893.77
3110231-11023194.75795.06
4108011-10801192.84993.14
5104106-10410689.49289.78
6109716-10971694.31594.61
20min1114134-11413498.11394.822.5998.5895.272.59
2110283-11028394.80295.25
3111585-11158595.92196.38
4109235-10923593.90194.35
5105545-10554590.72991.17
6111031-11103195.44595.90
30min1116169-11616999.86296.212.68100.4996.822.67
2111585-11158595.92196.53
3112848-11284897.00797.62
4110829-11082995.27295.88
5107084-10708492.05292.64
6112990-11299097.12997.74
极限1116997-116997100.57497.132.53101.3797.902.53
2112638-11263896.82797.60
3113873-11387397.88898.67
4111595-11159595.93096.69
5108503-10850393.27294.01
6114318-11431898.27199.05
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)0
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%
110.782252632253322251582252812254492252970.05
210.712245682246392246040.03
单位质量响应值RSD%判断
20899.5420971.430.25数据可信
中间条件12月-供试品溶液-b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%
5min1103931-10393189.18087.904.2389.1887.904.23
2104359-10435989.54789.55
393698-9369880.39980.40
4104466-10446689.63989.64
5104982-10498290.08290.08
6103215-10321588.56588.57
10min1110031-11003194.41493.473.9794.5693.623.97
2110731-11073195.01595.16
3100216-10021685.99286.13
4111541-11154195.71095.86
5111166-11116695.38895.54
6109903-10990394.30494.45
15min1112912-11291296.88695.603.9997.1995.913.99
2113035-11303596.99297.30
3102497-10249787.94988.23
4114340-11434098.11198.42
5113756-11375697.61097.92
6111965-11196596.07496.38
20min1113996-11399697.81696.803.9598.2897.263.95
2114741-11474198.45698.92
3103868-10386889.12689.55
4115341-11534198.97099.44
5115481-11548199.09099.56
6113460-11346097.35697.82
30min1115863-11586399.41898.514.36100.0599.134.36
2115780-11578099.34799.98
3104771-10477189.90190.47
4116774-116774100.200100.84
5117637-117637100.940101.58
6118001-118001101.253101.88
极限1117358-117358100.70199.314.22101.50100.104.22
2116879-116879100.290101.09
3105944-10594490.90791.63
4117882-117882101.151101.96
5119301-119301102.368103.17
6117083-117083100.465101.26
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)0
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%
110.782248672249712247662249062245192248060.08
210.712246852245432246140.05
单位质量响应值RSD%判断
20853.9920972.360.41数据可信
中间条件12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%
5min1101419-10141987.11884.572.7087.1284.572.70
297026-9702683.34483.34
397055-9705583.36983.37
494628-9462881.28481.28
5100962-10096286.72586.73
699629-9962985.58085.58
10min1108333-10833393.05790.193.0493.2090.343.04
2103572-10357288.96789.11
3103363-10336388.78788.93
4100166-10016686.04186.18
5108036-10803692.80292.95
6106513-10651391.49391.64
15min1110990-11099095.33992.403.0995.6492.693.08
2105915-10591590.98091.27
3106002-10600291.05491.34
4102652-10265288.17788.46
5111100-11110095.43395.73
6108764-10876493.42793.72
20min1112600-11260096.72293.872.9497.1894.312.94
2107791-10779192.59193.03
3107711-10771192.52292.96
4104366-10436689.64990.07
5112218-11221896.39496.85
6110978-11097895.32995.78
30min1114883-11488398.68395.423.0599.3096.023.05
2109190-10919093.79394.39
3109552-10955294.10494.70
4106044-10604491.09091.67
5113986-11398697.91298.53
6112820-11282096.91197.52
极限1117250-117250100.71697.382.69101.5098.142.69
2111796-11179696.03196.78
3111076-11107695.41396.16
4109410-10941093.98294.71
5115716-11571699.399100.18
6114921-11492198.71699.49
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)0
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%
110.782248512249102254782250772251012250830.11
210.712238612241972240290.11
单位质量响应值RSD%判断
20879.6820917.740.13数据可信
中间条件12月-供试品溶液-b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%
5min194750-9475081.44585.693.9881.4485.693.98
2104918-10491890.18590.18
3103874-10387489.28889.29
498539-9853984.70284.70
599075-9907585.16285.16
696965-9696583.34983.35
10min1102045-10204587.71591.393.6387.8591.543.63
2111358-11135895.72195.87
3110719-11071995.17195.32
4104568-10456889.88490.03
5105721-10572190.87591.02
6103516-10351688.98089.12
15min1103415-10341588.89393.713.7589.1794.003.75
2113571-11357197.62397.93
3113793-11379397.81498.12
4107345-10734592.27192.56
5109308-10930893.95894.25
6106682-10668291.70191.99
20min1104767-10476790.05595.363.4890.4995.813.48
2114686-11468698.58199.05
3115246-11524699.06399.53
4109098-10909893.77894.22
5110531-11053195.01095.46
6111304-11130495.67496.11
30min1106266-10626691.34496.443.8391.9297.053.82
2116772-116772100.374101.01
3117439-117439100.948101.58
4110459-11045994.94895.55
5112325-11232596.55297.16
6109903-10990394.47095.07
极限1108145-10814592.95998.464.2593.6999.244.25
2121156-121156104.143104.95
3119135-119135102.405103.21
4111879-11187996.16896.93
5114796-11479698.67699.45
6112186-11218696.43297.19
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)0
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%
110.782246932243992245252246702244702245510.06
210.712250072250122250100.01
单位质量响应值RSD%判断
20830.3321009.340.61数据可信
中间条件12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%
5min1106440-10644091.40289.454.0891.4089.454.08
2103438-10343888.82588.82
3102010-10201087.59887.60
4109634-10963494.14594.15
5106119-10611991.12791.13
697379-9737983.62283.62
10min1112368-11236896.49394.494.2096.6594.644.20
2110131-11013194.57294.72
3108745-10874593.38293.53
4115251-11525198.96999.13
5111967-11196796.14996.30
6101763-10176387.38687.53
15min1115049-11504998.79596.604.2099.1196.904.20
2112805-11280596.86897.17
3111154-11115495.45095.75
4117592-117592100.979101.30
5114407-11440798.24498.56
6103927-10392789.24489.53
20min1116120-11612099.71597.844.37100.1998.314.37
2114083-11408397.96698.43
3112321-11232196.45396.91
4120115-120115103.145103.64
5115704-11570499.35899.83
6105292-10529290.41790.85
30min1117664-117664101.04198.804.10101.6899.434.10
2115687-11568799.34399.97
3113172-11317297.18397.80
4120201-120201103.219103.88
5116937-116937100.416101.06
6106690-10669091.61792.20
极限1119101-119101102.27599.843.58103.09100.633.58
2116470-116470100.015100.81
3114363-11436398.20698.99
4121133-121133104.020104.85
5117296-117296100.725101.53
6109203-10920393.77594.51
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)0
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%
110.782249282245872250302246392246522247670.09
210.712232572233822233200.04
单位质量响应值RSD%判断
20850.3720851.540.01数据可信
中间条件12月-供试品溶液-b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%
5min1102971-10297188.71489.593.6888.7189.583.67
2108717-10871793.66493.66
3104680-10468090.18690.19
497367-9736783.88683.89
5106265-10626591.55291.55
6103895-10389589.51089.51
10min1109675-10967594.49095.683.9794.6495.833.97
2116446-116446100.323100.48
3111958-11195896.45796.61
4103360-10336089.04989.19
5113475-11347597.76497.92
6111394-11139495.97196.12
15min1115523-11552399.52898.974.2199.8399.284.21
2118914-118914102.450102.77
3115041-11504199.11399.42
4106257-10625791.54591.83
5119796-119796103.209103.52
6113738-11373897.99098.30
20min1113892-11389298.12398.763.8598.5999.233.85
2120239-120239103.591104.09
3115710-11571099.689100.17
4106877-10687792.07992.52
5116565-116565100.426100.91
6114486-11448698.63599.11
30min1115842-11584299.803100.364.12100.44101.004.11
2122496-122496105.536106.20
3116929-116929100.739101.38
4107912-10791292.97193.57
5118474-118474102.070102.73
6117270-117270101.033101.67
极限1116398-116398100.282101.054.04101.08101.854.04
2123256-123256106.190107.03
3118214-118214101.846102.66
4108994-10899493.90394.65
5119742-119742103.163103.99
6117126-117126100.909101.71
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