富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所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%
110.211733851737671733981735591736781735570.10
210.201738401737761738080.03
单位质量响应值RSD%判断
16998.7317040.000.18数据可信
供试品溶液-25052901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%
5min1183441-18344196.81195.911.4396.8195.911.43
2183578-18357896.88496.88
3177547-17754793.70193.70
4179695-17969594.83594.83
5184040-18404097.12897.13
6182135-18213596.12296.12
10min1186811-18681198.59098.021.5598.7598.181.55
2189269-18926999.887100.05
3182171-18217196.14196.30
4182375-18237596.24996.41
5187616-18761699.01599.18
6186092-18609298.21198.37
15min1185994-18599498.15997.861.5498.4898.181.53
2189659-189659100.093100.42
3181495-18149595.78496.10
4183095-18309596.62996.95
5186263-18626398.30198.63
6186092-18609298.21198.53
20min1186204-18620498.27097.761.3598.7698.251.35
2188382-18838299.41999.91
3182571-18257196.35296.83
4181975-18197596.03896.52
5186831-18683198.60199.09
6185521-18552197.90998.40
30min1185579-18557997.94097.821.5198.5998.471.51
2189612-189612100.068100.73
3182408-18240896.26696.90
4182152-18215296.13196.77
5186624-18662498.49199.15
6185730-18573098.01998.67
45min1186432-18643298.39097.741.6899.2198.551.68
2190001-190001100.274101.10
3181833-18183395.96396.76
4181850-18185095.97296.77
5186186-18618698.26099.08
6184868-18486897.56598.38
极限1188211-18821199.32998.231.72100.3199.201.72
2190164-190164100.360101.35
3181955-18195596.02796.98
4182869-18286996.51097.47
5187602-18760299.00799.99
6185969-18596998.14699.12
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所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%
110.211735381735651732471737311736701735500.11
210.201720441722691721560.10
单位质量响应值RSD%判断
16998.0416878.040.51数据可信
供试品溶液-25052902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%
5min1182008-18200896.51796.221.2696.5296.221.26
2183334-18333497.22197.22
3179675-17967595.28095.28
4179781-17978195.33695.34
5179123-17912394.98894.99
6184730-18473097.96197.96
10min1184989-18498998.09898.000.6998.2698.160.69
2186435-18643598.86599.03
3184122-18412297.63897.80
4183973-18397397.55997.72
5183215-18321597.15897.32
6186048-18604898.66098.82
15min1184843-18484398.02198.140.7198.3598.470.71
2186538-18653898.92099.25
3183823-18382397.48097.80
4185211-18521198.21698.54
5183477-18347797.29697.62
6186540-18654098.92199.25
20min1185671-18567198.46098.000.8098.9598.490.80
2186506-18650698.90399.39
3183369-18336997.23997.72
4184744-18474497.96898.45
5182788-18278896.93197.41
6185760-18576098.50799.00
30min1185569-18556998.40698.310.7099.0698.960.70
2186960-18696099.14399.80
3184041-18404197.59698.24
4185411-18541198.32298.97
5183791-18379197.46398.11
6186596-18659698.95099.61
45min1185157-18515798.18798.140.6099.0098.950.60
2186807-18680799.06299.88
3184268-18426897.71698.52
4184754-18475497.97498.79
5183679-18367997.40498.21
6185748-18574898.50199.32
极限1187786-18778699.58198.591.05100.5699.571.05
2188618-188618100.023101.01
3183990-18399097.56898.54
4184235-18423597.69898.67
5184662-18466297.92598.89
6186204-18620498.74399.73
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所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%
110.211739481732741736831737181734331736110.16
210.201727741722861725300.21
单位质量响应值RSD%判断
17004.0216914.710.38数据可信
供试品溶液-25052903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%
5min1175777-17577793.09595.761.8593.1095.761.84
2182379-18237996.59296.59
3183194-18319497.02497.02
4180423-18042395.55695.56
5178279-17827994.42194.42
6184740-18474097.84297.84
10min1179260-17926094.94097.331.7695.1097.491.76
2184677-18467797.80997.97
3187051-18705199.06699.23
4182977-18297796.90997.07
5181247-18124795.99396.15
6187384-18738499.24399.41
15min1178887-17888794.74397.281.8595.0697.601.85
2184386-18438697.65597.98
3186763-18676398.91499.24
4183087-18308796.96797.29
5181093-18109395.91196.23
6187860-18786099.49599.82
20min1178439-17843994.50597.161.9194.9897.641.90
2184182-18418297.54798.03
3186400-18640098.72299.21
4182971-18297196.90697.39
5180862-18086295.78996.27
6187870-18787099.50099.99
30min1178179-17817994.36897.001.8895.0097.651.88
2183821-18382197.35698.01
3186187-18618798.60999.27
4182209-18220996.50297.15
5181019-18101995.87296.51
6187518-18751899.31499.97
45min1178046-17804694.29796.841.8295.0897.651.82
2183718-18371897.30198.11
3185539-18553998.26699.09
4182497-18249796.65597.46
5180305-18030595.49496.29
6186993-18699399.03699.86
极限1180523-18052395.60997.511.6696.5598.481.66
2185695-18569598.34899.32
3186672-18667298.86699.85
4183425-18342597.14698.11
5180705-18070595.70596.66
6187619-18761999.367100.36
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所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%
110.211734481733801733871731281731281732940.09
210.201719501722341720920.12
单位质量响应值RSD%判断
16972.9716871.760.43数据可信
供试品溶液-25052901批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1187551-18755199.54998.142.3299.5598.142.32
2187678-18767899.61699.62
3187202-18720299.36399.36
4180734-18073495.93095.93
5188043-18804399.81099.81
6178229-17822994.60194.60
10min1187847-18784799.70698.412.5399.8798.572.53
2189207-189207100.428100.59
3188327-18832799.961100.13
4180699-18069995.91296.07
5188106-18810699.843100.01
6178255-17825594.61494.77
15min1188281-18828199.93698.352.66100.2798.682.66
2188992-188992100.313100.65
3188774-188774100.198100.53
4180246-18024695.67195.99
5187624-18762499.58799.92
6177877-17787794.41494.73
20min1187655-18765599.60497.942.46100.1098.432.46
2187814-18781499.688100.19
3187250-18725099.38999.89
4180066-18006695.57696.05
5186818-18681899.16099.66
6177512-17751294.22094.69
30min1188165-18816599.87597.822.62100.5498.482.62
2187619-18761999.585100.25
3187156-18715699.339100.00
4179896-17989695.48596.12
5186337-18633798.90499.57
6176643-17664393.75994.39
45min1187235-18723599.38197.692.61100.2198.512.61
2187351-18735199.442100.28
3187199-18719999.362100.19
4179598-17959895.32796.12
5186529-18652999.00699.83
6176439-17643993.65194.44
极限1186658-18665899.07597.382.65100.0798.362.65
2186881-18688199.193100.19
3186698-18669899.096100.09
4178613-17861394.80495.76
5185968-18596898.70899.70
6176026-17602693.43194.37
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所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%
110.211725111729511726581728681729301727840.12
210.201735261733321734290.08
单位质量响应值RSD%判断
16923.0217002.840.34数据可信
供试品溶液-25052902批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186268-18626898.63198.781.4098.6398.781.40
2190463-190463100.852100.85
3185786-18578698.37698.38
4188401-18840199.76099.76
5185524-18552498.23798.24
6182895-18289596.84596.84
10min1187478-18747899.27299.651.4699.4499.821.46
2192422-192422101.889102.06
3187640-18764099.35799.52
4189307-189307100.240100.41
5188280-18828099.69699.86
6184027-18402797.44497.61
15min1187776-18777699.42999.531.5299.7699.861.52
2192004-192004101.668102.01
3187411-18741199.23699.57
4188936-188936100.044100.38
5188432-18843299.777100.11
6183199-18319997.00697.33
20min1188151-18815199.62899.761.43100.12100.251.43
2192384-192384101.869102.38
3187404-18740499.23299.73
4189445-189445100.313100.81
5188800-18880099.972100.47
6184174-18417497.52298.01
30min1187703-18770399.39199.591.45100.05100.251.45
2192251-192251101.799102.48
3187315-18731599.18599.85
4189047-189047100.102100.77
5188243-18824399.677100.34
6183884-18388497.36998.02
45min1187402-18740299.23199.311.47100.06100.141.46
2191527-191527101.416102.26
3186940-18694098.98799.81
4188759-18875999.950100.78
5187589-18758999.330100.16
6183097-18309796.95297.76
极限1186957-18695798.99699.181.3499.99100.181.34
2191222-191222101.254102.27
3186052-18605298.51699.51
4188172-18817299.639100.64
5187755-18775599.418100.41
6183689-18368997.26598.24
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