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%
1 9.871665991667001671411671191670141669150.15
2 9.861663161662831663000.02
单位质量响应值RSD%判断
16911.3516866.130.19数据可信
供试品溶液-25011501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%
5min1182943-18294397.29598.831.3197.3098.831.31
2189589-189589100.830100.83
3183495-18349597.58997.59
4186272-18627299.06699.07
5185706-18570698.76598.76
6186959-18695999.43199.43
10min1183070-18307097.36398.971.1497.5399.141.14
2189259-189259100.655100.82
3184509-18450998.12898.29
4186525-18652599.20099.37
5186420-18642099.14599.31
6186808-18680899.35199.52
15min1182474-18247497.04698.611.1697.3798.941.16
2188405-188405100.200100.54
3183432-18343297.55697.88
4186072-18607298.96099.29
5185957-18595798.89899.23
6186168-18616899.01199.34
20min1181638-18163896.60198.191.1997.0998.691.19
2187829-18782999.894100.40
3182785-18278597.21197.70
4184983-18498398.38098.88
5184938-18493898.35698.85
6185601-18560198.70999.21
30min1181104-18110496.31798.061.2596.9698.721.26
2187796-18779699.876100.55
3182639-18263997.13497.78
4184751-18475198.25798.92
5184686-18468698.22298.88
6185298-18529898.54899.21
45min1180032-18003295.74797.541.2396.5598.361.24
2186768-18676899.330100.17
3182007-18200796.79897.61
4183623-18362397.65798.48
5183826-18382697.76598.59
6184153-18415397.93998.76
极限1179543-17954395.48797.091.2096.4598.081.20
2185910-18591098.87399.87
3180964-18096496.24397.22
4182367-18236796.98997.97
5183282-18328297.47698.46
6183308-18330897.49098.48
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%
1 9.871659481656291655811655641655591656560.10
2 9.861653491651371652430.10
单位质量响应值RSD%判断
16783.7916758.920.11数据可信
供试品溶液-25011501批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1185741-18574199.47599.221.7999.4799.221.79
2185406-18540699.29599.30
3183050-18305098.03498.03
4182206-18220697.58297.58
5183751-18375198.40998.41
6191422-191422102.517102.52
10min1186994-186994100.146100.111.69100.31100.281.69
2187311-187311100.316100.48
3184634-18463498.88299.05
4183848-18384898.46198.62
5186063-18606399.64799.81
6192735-192735103.220103.39
15min1187352-187352100.338100.121.60100.67100.451.60
2187182-187182100.246100.58
3184630-18463098.88099.21
4183498-18349898.27398.60
5186843-186843100.065100.40
6192114-192114102.888103.23
20min1186985-186985100.14199.791.64100.64100.291.64
2187132-187132100.220100.72
3184371-18437198.74199.23
4182895-18289597.95198.44
5185043-18504399.10199.60
6191605-191605102.615103.13
30min1187526-187526100.43199.791.61101.10100.451.61
2186804-186804100.044100.71
3184532-18453298.82799.48
4182697-18269797.84598.50
5185063-18506399.11299.77
6191331-191331102.469103.15
45min1186446-18644699.85299.431.58100.69100.261.58
2185949-18594999.586100.42
3183815-18381598.44399.27
4182556-18255697.76998.59
5184288-18428898.69799.52
6190859-190859102.216103.07
极限1186419-18641999.83899.191.66100.84100.191.66
2185403-18540399.294100.29
3183307-18330798.17199.16
4181882-18188297.40898.39
5183712-18371298.38899.38
6190559-190559102.055103.08
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%
1 9.871657221656161658321657671658541657580.06
2 9.861652331651161651740.06
单位质量响应值RSD%判断
16794.1216751.930.18数据可信
供试品溶液-25011501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%
5min1182324-18232497.63598.182.0497.6498.182.04
2185820-18582099.50799.51
3185498-18549899.33599.33
4188094-188094100.725100.73
5179276-17927696.00396.00
6179031-17903195.87295.87
10min1183920-18392098.49099.601.8698.6599.761.86
2188458-188458100.920101.09
3188209-188209100.787100.95
4190374-190374101.946102.11
5181866-18186697.39097.55
6183159-18315998.08298.24
15min1184340-18434098.71599.521.7699.0499.851.76
2188362-188362100.869101.20
3187503-187503100.409100.74
4190035-190035101.764102.10
5181708-18170897.30597.63
6183129-18312998.06698.39
20min1183955-18395598.50999.301.8999.0099.801.90
2187981-187981100.664101.17
3187601-187601100.461100.96
4189772-189772101.624102.13
5181157-18115797.01097.49
6182141-18214197.53798.02
30min1183470-18347098.24999.121.8198.9099.781.81
2187417-187417100.362101.03
3187528-187528100.422101.09
4189086-189086101.256101.93
5181047-18104796.95197.60
6182044-18204497.48598.13
45min1183414-18341498.21998.781.8299.0499.601.82
2186696-18669699.976100.81
3186610-18661099.930100.77
4188584-188584100.987101.83
5180418-18041896.61497.42
6181005-18100596.92997.74
极限1182556-18255697.75998.631.8998.7499.621.89
2187128-187128100.208101.21
3185943-18594399.573100.58
4188431-188431100.905101.92
5180007-18000796.39497.36
6180985-18098596.91897.89
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%
1 9.871658521658961658411655901660851658530.11
2 9.861657621657031657320.03
单位质量响应值RSD%判断
16803.7516808.520.03数据可信
供试品溶液-25011501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%
5min1157896-15789684.38776.1314.8584.3976.1314.85
2154678-15467882.66782.67
3154910-15491082.79182.79
4124522-12452266.55166.55
5155051-15505182.86782.87
6107623-10762357.51957.52
10min1169800-16980090.74987.356.2490.8987.476.25
2169251-16925190.45690.59
3169774-16977490.73590.87
4157606-15760684.23284.34
5169111-16911190.38190.52
6145049-14504977.52177.62
15min1177030-17703094.61392.533.2194.9192.803.23
2175297-17529793.68793.98
3176452-17645294.30494.59
4173807-17380792.89193.14
5174085-17408593.03993.33
6162096-16209686.63286.86
20min1180611-18061196.52795.101.7896.9895.531.80
2177966-17796695.11495.56
3180495-18049596.46596.91
4179553-17955395.96296.37
5176819-17681994.50194.94
6172233-17223392.05092.42
30min1183800-18380098.23197.111.2298.8497.701.24
2180830-18083096.64497.25
3184359-18435998.53099.14
4182454-18245497.51298.08
5180192-18019296.30396.90
6178624-17862495.46595.99
45min1184061-18406198.37197.141.2999.1597.881.30
2179908-17990896.15196.92
3184445-18444598.57699.35
4183020-18302097.81598.54
5179664-17966496.02196.78
6179420-17942095.89196.57
极限1183028-18302897.81996.681.1798.7697.601.18
2179781-17978196.08497.01
3183091-18309197.85398.79
4182106-18210697.32698.22
5179210-17921095.77896.70
6178221-17822195.25096.09
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%
1 9.871663601661521663301662691663481662920.06
2 9.861648621648641648630.01
单位质量响应值RSD%判断
16848.2316720.390.54数据可信
供试品溶液-25011501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%
5min1133391-13339171.38469.0818.0271.3869.0818.02
2147182-14718278.76578.76
388777-8877747.50947.51
4154470-15447082.66582.66
5130928-13092870.06670.07
6119798-11979864.11064.11
10min1148800-14880079.63078.2013.5079.7578.3213.50
2162089-16208986.74286.87
3116261-11626162.21762.30
4170971-17097191.49591.63
5145718-14571877.98178.10
6132978-13297871.16371.27
15min1158069-15806984.59184.1211.7984.8484.3611.80
2174373-17437393.31693.59
3133200-13320071.28271.46
4181321-18132197.03497.32
5154998-15499882.94783.19
6141156-14115675.54075.77
20min1165126-16512688.36788.449.6888.7688.839.69
2182379-18237997.60098.03
3147395-14739578.87979.18
4185095-18509599.05499.51
5162572-16257287.00087.39
6149003-14900379.73980.09
30min1174429-17442993.34694.435.8393.8994.965.86
2188424-188424100.835101.43
3167521-16752189.64990.08
4187904-187904100.557101.17
5177055-17705594.75195.28
6163421-16342187.45587.94
45min1179825-17982596.23398.282.9396.9398.972.97
2190666-190666102.035102.80
3179795-17979596.21796.80
4188336-188336100.788101.57
5185857-18585799.461100.15
6177430-17743094.95295.58
极限1184495-18449598.733100.921.6299.59101.771.65
2191427-191427102.442103.37
3186667-18666799.895100.64
4190155-190155101.762102.71
5192023-192023102.761103.61
6186679-18667999.901100.69
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