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%
110.101702841693121691211700251707901699060.41
210.051707381712791710080.23
单位质量响应值RSD%判断
16822.3817015.720.81数据可信
供试品溶液-2025120221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%
5min1186773-18677399.157100.071.1899.16100.071.18
2190090-190090100.918100.92
3189313-189313100.506100.51
4191127-191127101.469101.47
5185106-18510698.27298.27
6188533-188533100.092100.09
10min1187816-18781699.711101.051.1799.88101.221.17
2191437-191437101.634101.80
3191523-191523101.679101.85
4193393-193393102.672102.84
5187859-18785999.73499.90
6189992-189992100.866101.03
15min1187511-18751199.549100.861.0799.88101.191.07
2191202-191202101.509101.85
3190519-190519101.146101.48
4192860-192860102.389102.73
5187944-18794499.779100.11
6189802-189802100.766101.10
20min1187227-18722799.398100.581.1299.90101.081.12
2190726-190726101.256101.76
3189696-189696100.709101.21
4192677-192677102.292102.80
5187165-18716599.36699.86
6189180-189180100.435100.94
30min1187037-18703799.298100.551.0899.96101.221.08
2190350-190350101.056101.73
3189729-189729100.727101.40
4192538-192538102.218102.90
5187319-18731999.447100.11
6189373-189373100.538101.21
45min1186584-18658499.057100.411.2499.89101.251.24
2190257-190257101.007101.85
3189363-189363100.532101.37
4193017-193017102.472103.32
5187121-18712199.342100.17
6188498-188498100.073100.91
极限1186945-18694599.249100.341.02100.24101.351.02
2189822-189822100.776101.79
3189332-189332100.516101.52
4192122-192122101.997103.02
5187160-18716099.363100.36
6188672-188672100.166101.17
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%
110.101696081696201696321694131695471695640.06
210.051695481700851698160.23
单位质量响应值RSD%判断
16788.5116897.110.46数据可信
供试品溶液-2025120321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%
5min1189146-189146100.87099.980.83100.8799.980.83
2187689-187689100.093100.09
3187878-187878100.193100.19
4188918-188918100.748100.75
5185724-18572499.04599.04
6185522-18552298.93798.94
10min1189951-189951101.299100.301.08101.47100.471.08
2189242-189242100.921101.09
3187886-187886100.198100.36
4190042-190042101.347101.52
5185712-18571299.03899.20
6185630-18563098.99499.16
15min1189722-189722101.177100.140.99101.51100.480.99
2188586-188586100.571100.91
3187678-187678100.087100.42
4189499-189499101.058101.39
5186011-18601199.19899.53
6185195-18519598.76399.09
20min1189046-189046100.81699.910.92101.32100.410.92
2188225-188225100.378100.88
3187301-18730199.886100.39
4188923-188923100.751101.26
5185430-18543098.88899.38
6185143-18514398.73599.23
30min1188937-188937100.75899.780.99101.43100.440.99
2188025-188025100.272100.94
3186903-18690399.673100.34
4188884-188884100.730101.40
5185137-18513798.73299.39
6184683-18468398.48999.15
45min1188489-188489100.51999.590.92101.36100.430.93
2187281-18728199.875100.71
3186800-18680099.618100.45
4188520-188520100.536101.38
5184604-18460498.44799.27
6184824-18482498.56599.39
极限1188618-188618100.58899.660.99101.60100.660.99
2187878-187878100.193101.20
3187225-18722599.845100.84
4188354-188354100.447101.46
5184934-18493498.62399.61
6184289-18428998.27999.27
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%
110.101709641708811706321704021706861707130.13
210.051704171702991703580.05
单位质量响应值RSD%判断
16902.2816951.040.21数据可信
供试品溶液-2025120421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%
5min1190108-190108100.880100.290.69100.88100.290.69
2187965-18796599.74299.74
3188066-18806699.79699.80
4188325-18832599.93399.93
5188443-18844399.996100.00
6191104-191104101.408101.41
10min1191776-191776101.765101.130.53101.93101.300.53
2189367-189367100.486100.65
3189995-189995100.820100.99
4190057-190057100.852101.02
5190526-190526101.101101.27
6191797-191797101.776101.94
15min1192023-192023101.896100.990.54102.23101.330.54
2189482-189482100.547100.88
3189576-189576100.597100.93
4190004-190004100.824101.16
5189754-189754100.692101.03
6191064-191064101.387101.73
20min1191767-191767101.760100.760.71102.27101.270.71
2188630-188630100.095100.60
3189347-189347100.476100.98
4188755-188755100.162100.66
5189470-189470100.541101.04
6191369-191369101.549102.06
30min1191059-191059101.384100.670.57102.06101.340.57
2188340-18834099.941100.61
3188963-188963100.272100.94
4189604-189604100.612101.28
5189489-189489100.551101.22
6190874-190874101.286101.96
45min1190633-190633101.158100.340.57102.00101.180.57
2187991-18799199.756100.59
3188337-18833799.940100.78
4188416-18841699.982100.82
5189023-189023100.304101.14
6190164-190164100.909101.75
极限1190604-190604101.143100.300.64102.16101.310.64
2187765-18776599.636100.64
3188477-188477100.014101.02
4188239-18823999.888100.89
5188564-188564100.060101.07
6190453-190453101.063102.08
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%
110.101703341703711700711700481702601702170.09
210.051700251701051700650.04
单位质量响应值RSD%判断
16853.1716921.890.29数据可信
供试品溶液-G01T79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%
5min1138054-13805473.42774.129.5873.4374.129.58
2133581-13358171.04871.05
3162738-16273886.55686.56
4122587-12258765.20165.20
5143284-14328476.20976.21
6135891-13589172.27772.28
10min1176702-17670293.98391.395.5494.1191.525.54
2170905-17090590.90091.02
3183502-18350297.60097.74
4156242-15624283.10183.21
5176728-17672893.99794.12
6166911-16691188.77688.90
15min1183823-18382397.77196.313.4098.0596.593.41
2182056-18205696.83197.10
3186138-18613899.00299.31
4169817-16981790.32190.57
5185854-18585498.85199.13
6178820-17882095.11095.38
20min1184031-18403197.88197.702.0298.3298.142.03
2184665-18466598.21998.65
3186237-18623799.05599.53
4176452-17645293.85094.25
5186559-18655999.22699.67
6184184-18418497.96398.39
30min1184018-18401897.87498.360.9698.4898.960.97
2185549-18554998.68999.28
3186528-18652899.20999.85
4181759-18175996.67397.23
5185746-18574698.79399.41
6185934-18593498.89399.48
45min1184056-18405697.89598.500.8098.6699.260.81
2185474-18547498.64999.41
3186069-18606998.96599.77
4182813-18281397.23397.95
5186146-18614699.00699.78
6186617-18661799.257100.01
极限1183304-18330497.49598.230.7198.4399.160.72
2184485-18448598.12399.05
3185433-18543398.62799.59
4183041-18304197.35598.23
5185689-18568998.76399.71
6186204-18620499.03799.96
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