培哚普利叔丁胺项目信息
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101072-202303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1000
标示量(mg)4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%
110.244408814417004422584419884425914418840.15
210.184401794397244399520.08
单位质量响应值RSD%判断
43152.7343217.290.11数据可信
供试品溶液-2023091311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%
5min1123101-12310164.00970.5412.7364.0170.5412.73
2144348-14434875.05775.06
3115399-11539960.00460.00
4164465-16446585.51785.52
5135054-13505470.22470.22
6131639-13163968.44968.45
10min1186438-18643896.94397.621.2497.0597.741.24
2191737-19173799.69899.82
3184859-18485996.12296.22
4187742-18774297.62197.76
5187260-18726097.37097.49
6188436-18843697.98298.10
15min1188307-18830797.91498.670.9898.1898.950.99
2193192-193192100.455100.75
3188442-18844297.98598.24
4188849-18884998.19698.50
5189289-18928998.42598.70
6190449-19044999.02899.31
20min1187663-18766397.58098.630.9798.0199.070.97
2192651-192651100.173100.63
3189087-18908798.32098.74
4188644-18864498.09098.56
5189009-18900998.27998.72
6191048-19104899.34099.78
30min1187298-18729897.39098.540.9397.9899.150.93
2192122-19212299.898100.52
3189241-18924198.40098.99
4188426-18842697.97698.61
5189029-18902998.29098.90
6190966-19096699.29799.91
培哚普利叔丁胺项目信息
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101072-202303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1000
标示量(mg)4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%
110.244407894408604402254404594400594404780.08
210.184388784395874392320.12
单位质量响应值RSD%判断
43015.4343146.560.22数据可信
供试品溶液-2023091311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%
5min1148000-14800077.14268.337.6777.1468.337.67
2133170-13317069.41269.41
3131729-13172968.66168.66
4128250-12825066.84866.85
5116969-11696960.96860.97
6128450-12845066.95266.95
10min1189569-18956998.80997.571.7098.9497.681.71
2189866-18986698.96499.08
3187170-18717097.55897.67
4186682-18668297.30497.42
5181247-18124794.47194.57
6188590-18859098.29998.41
15min1188179-18817998.08498.260.9798.3898.540.97
2190616-19061699.35599.64
3188544-18854498.27598.55
4188619-18861998.31498.59
5185311-18531196.58996.85
6189807-18980798.93399.21
20min1188752-18875298.38398.410.9998.8498.850.99
2190978-19097899.54399.99
3188487-18848798.24598.69
4189143-18914398.58799.02
5185499-18549996.68797.11
6189985-18998599.02699.47
30min1188027-18802798.00598.320.7798.6398.920.77
2190451-19045199.26999.88
3187930-18793097.95598.56
4189538-18953898.79399.39
5186434-18643497.17597.76
6189357-18935798.69899.30
培哚普利叔丁胺项目信息
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101072-202303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1000
标示量(mg)4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%
110.244395674384084397424396514393924393520.13
210.184370974366204368580.08
单位质量响应值RSD%判断
42905.4742913.360.02数据可信
供试品溶液-2023091211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%
5min1111009-11100958.09272.9924.7958.0972.9924.79
2186856-18685697.78497.78
3112884-11288459.07459.07
4136506-13650671.43571.44
5112053-11205358.63958.64
6177563-17756392.92192.92
10min1185912-18591297.29097.442.9397.3997.562.94
2191636-191636100.285100.45
3183224-18322495.88395.98
4191306-191306100.113100.23
5177216-17721692.73992.84
6187878-18787898.31998.47
15min1189547-18954799.19298.732.1099.4599.012.10
2191297-191297100.108100.44
3189999-18999999.42999.69
4192319-192319100.643100.93
5181360-18136094.90895.16
6187409-18740998.07398.39
20min1189260-18926099.04298.781.8799.4799.231.88
2191389-191389100.156100.65
3189796-18979699.32299.75
4192191-192191100.576101.03
5182376-18237695.44095.85
6187522-18752298.13298.61
30min1192203-192203100.58299.012.09101.1799.632.10
2191358-191358100.140100.80
3189010-18901098.91199.50
4192690-192690100.837101.46
5182102-18210295.29695.87
6187863-18786398.31198.96
培哚普利叔丁胺项目信息
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101072-202303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1000
标示量(mg)4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%
110.244365674369474361914364624356204363570.12
210.184369284379244374260.17
单位质量响应值RSD%判断
42612.9942969.160.59数据可信
供试品溶液-2023091211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%
5min1111896-11189658.71958.871.8658.7258.871.86
2115135-11513560.41960.42
3108807-10880757.09857.10
4111851-11185158.69658.70
5112006-11200658.77758.78
6113370-11337059.49359.49
10min1188087-18808798.70296.681.3298.8096.781.32
2184251-18425196.68996.79
3182074-18207495.54795.64
4184404-18440496.76996.87
5181277-18127795.12895.23
6185324-18532497.25297.35
15min1191175-191175100.32399.051.02100.5899.311.02
2189940-18994099.67499.94
3186018-18601897.61697.87
4188660-18866099.00399.26
5187109-18710998.18998.45
6189651-18965199.52399.78
20min1191368-191368100.42499.091.13100.8599.521.13
2190262-19026299.843100.27
3185685-18568597.44297.86
4188516-18851698.92799.35
5187191-18719198.23298.65
6189987-18998799.699100.13
30min1190809-190809100.13099.151.32100.7399.741.32
2191283-191283100.379100.97
3184773-18477396.96397.54
4188951-18895199.15599.74
5187391-18739198.33798.92
6190424-19042499.928100.52
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