普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.631108091117291115631117251116761115000.36
216.661116261116081116170.02
单位质量响应值RSD%判断
6704.756699.700.06数据可信
中间条件36月-供试品溶液-2022101211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%
2min1105923-10592394.25694.010.8894.2694.010.88
2105862-10586294.20294.20
3105864-10586494.20394.20
4104733-10473393.19793.20
5107003-10700395.21795.22
6104470-10447092.96392.96
5min1108642-10864296.67697.850.9096.6897.850.90
2109875-10987597.77397.77
3110666-11066698.47798.48
4110254-11025498.11098.11
5111270-11127099.01499.01
6109067-10906797.05497.05
10min1109682-10968297.60198.090.5697.6098.090.56
2109679-10967997.59897.60
3110287-11028798.13998.14
4110728-11072898.53298.53
5111173-11117398.92898.93
6109865-10986597.76497.76
15min1109519-10951997.45698.200.9097.4698.200.90
2109654-10965497.57697.58
3110472-11047298.30498.30
4111271-11127199.01599.01
5111758-11175899.44899.45
6109434-10943497.38097.38
30min1109396-10939697.34698.161.0297.3598.161.02
2109506-10950697.44497.44
3110321-11032198.17098.17
4111422-11142299.14999.15
5111895-11189599.57099.57
6109317-10931797.27697.28
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.631114501118321116271114251117101116090.16
216.661109941112971111460.20
单位质量响应值RSD%判断
6711.306671.430.43数据可信
中间条件36月-供试品溶液-2022101411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%
2min1103375-10337592.13992.350.9992.1492.350.99
2104177-10417792.85492.85
3105389-10538993.93493.93
4102772-10277291.60191.60
5103296-10329692.06892.07
6102661-10266191.50291.50
5min1110439-11043998.43596.841.5698.4396.841.56
2109838-10983897.89997.90
3109545-10954597.63897.64
4105970-10597094.45294.45
5108701-10870196.88696.89
6107387-10738795.71595.71
10min1110800-11080098.75797.750.9398.7697.760.93
2110465-11046598.45898.46
3110144-11014498.17298.17
4108544-10854496.74696.75
5109730-10973097.80397.80
6108366-10836696.58796.59
15min1110958-11095898.89797.901.1798.9097.901.17
2110604-11060498.58298.58
3110552-11055298.53698.54
4109320-10932097.43897.44
5110122-11012298.15298.15
6107506-10750695.82195.82
30min1110855-11085598.80698.091.0598.8198.091.05
2110921-11092198.86598.86
3110964-11096498.90398.90
4109363-10936397.47697.48
5110168-11016898.19398.19
6108064-10806496.31896.32
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.631115411114321114131114921115691114890.07
216.661110951110591110770.03
单位质量响应值RSD%判断
6704.096667.290.39数据可信
中间条件36月-供试品溶液-2022101511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%
2min1104949-10494993.62193.801.1993.6293.801.19
2104898-10489893.57593.58
3105306-10530693.93993.94
4105562-10556294.16894.17
5103151-10315192.01792.02
6107013-10701395.46295.46
5min1110616-11061698.67698.200.6698.6898.200.66
2110287-11028798.38398.38
3109686-10968697.84797.85
4110979-11097999.00099.00
5108928-10892897.17097.17
6109965-10996598.09698.10
10min1110874-11087498.90699.050.6198.9199.060.61
2111321-11132199.30599.31
3110862-11086298.89698.90
4111276-11127699.26599.27
5109949-10994998.08198.08
6111954-11195499.87099.87
15min1111714-11171499.65699.330.5599.6699.330.55
2111533-11153399.49499.49
3111113-11111399.12099.12
4111359-11135999.33999.34
5110296-11029698.39198.39
6112068-11206899.97299.97
30min1111791-11179199.72499.520.6099.7299.520.60
2111994-11199499.90699.91
3111076-11107699.08799.09
4111877-11187799.80199.80
5110448-11044898.52698.53
6112176-112176100.068100.07
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.631115611115601115141114121114711115040.06
216.661103711108281106000.30
单位质量响应值RSD%判断
6704.996638.660.71数据可信
中间条件36月-供试品溶液-EP4189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%
2min170806-7080663.29666.214.1863.3066.214.18
273045-7304565.29765.30
375108-7510867.14167.14
471944-7194464.31364.31
573895-7389566.05766.06
679596-7959671.15371.15
5min1106481-10648195.18793.851.7295.1993.851.72
2105174-10517494.01894.02
3104167-10416793.11893.12
4102166-10216691.32991.33
5104653-10465393.55393.55
6107274-10727495.89695.90
10min1113140-113140101.13999.551.06101.1499.551.06
2111499-11149999.67299.67
3111738-11173899.88699.89
4109803-10980398.15698.16
5110319-11031998.61898.62
6111651-11165199.80899.81
15min1112563-112563100.62499.931.08100.6299.931.08
2113181-113181101.176101.18
3111859-11185999.99499.99
4110439-11043998.72598.72
5110244-11024498.55098.55
6112426-112426100.501100.50
30min1112554-112554100.61599.901.01100.6299.901.02
2112170-112170100.272100.27
3111939-111939100.066100.07
4110809-11080999.05699.06
5110013-11001398.34498.34
6113014-113014101.027101.03
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