苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.569663996593965899672196556966200.07
219.499641096510964600.08
单位质量响应值RSD%判断
4939.674949.200.14数据可信
供试品溶液-2025042421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%
5min197943-97943101.18498.322.08101.1898.322.08
294689-9468997.82397.82
395740-9574098.90998.91
495225-9522598.37798.38
595597-9559798.76198.76
691843-9184394.88394.88
10min199655-99655102.953100.861.45103.12101.021.45
296755-9675599.957100.12
398220-98220101.471101.64
498171-98171101.420101.58
597442-97442100.667100.83
695519-9551998.68098.84
15min199688-99688102.987101.021.32103.33101.351.32
296859-96859100.065100.39
398165-98165101.414101.75
498386-98386101.642101.98
597588-97588100.818101.15
696000-9600099.17799.50
20min199493-99493102.786100.721.36103.30101.221.37
296008-9600899.18599.68
398031-98031101.275101.78
497991-97991101.234101.74
597387-97387100.610101.11
696074-9607499.25499.74
30min199323-99323102.610100.481.25103.29101.141.25
296422-9642299.613100.27
397445-97445100.670101.34
497702-97702100.936101.61
596807-96807100.011100.68
695853-9585399.02599.68
45min198934-98934102.208100.331.29103.06101.161.29
296135-9613599.317100.14
397393-97393100.616101.46
497397-97397100.620101.46
597509-97509100.736101.57
695325-9532598.48099.30
极限198803-98803102.073100.061.23103.10101.061.24
296118-9611899.299100.29
397211-97211100.428101.44
497200-97200100.417101.42
596444-9644499.636100.64
695336-9533698.49199.47
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.569644296573965109640096434964720.08
219.499623196104961680.10
单位质量响应值RSD%判断
4932.114934.220.04数据可信
供试品溶液-2025042421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%
5min196688-96688100.11697.812.80100.1297.812.80
297316-97316100.766100.77
392260-9226095.53195.53
496569-9656999.99399.99
591803-9180395.05895.06
692119-9211995.38595.39
10min197296-97296100.746100.131.39100.91100.301.39
298275-98275101.759101.93
394991-9499198.35998.52
497514-97514100.971101.14
596992-96992100.431100.59
695143-9514398.51698.68
15min197701-97701101.165100.081.77101.50100.411.76
298546-98546102.040102.38
394637-9463797.99298.32
497395-97395100.848101.18
597210-97210100.657100.98
694446-9444697.79598.12
20min196901-96901100.33799.911.64100.84100.401.64
298329-98329101.815102.32
394749-9474998.10898.59
496885-96885100.320100.82
597649-97649101.111101.60
694415-9441597.76398.25
30min197221-97221100.66899.651.64101.34100.311.64
297644-97644101.106101.78
394647-9464798.00398.65
496686-96686100.114100.78
597330-97330100.781101.44
693892-9389297.22197.87
45min196972-96972100.41099.391.76101.25100.221.76
296993-96993100.432101.28
394366-9436697.71298.53
497121-97121100.564101.40
597133-97133100.577101.41
693344-9334496.65497.46
极限196613-96613100.03899.321.78101.04100.311.78
297872-97872101.342102.36
394235-9423597.57698.55
496148-9614899.557100.56
597148-97148100.592101.59
693496-9349696.81197.78
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.561930621936311933151933121934461933530.11
219.491931101924961928030.23
单位质量响应值RSD%判断
9885.129892.410.06数据可信
供试品溶液-2025042221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%
5min1184864-18486495.49294.472.1495.4994.472.14
2181527-18152793.76893.77
3181348-18134893.67693.68
4177806-17780691.84691.85
5189389-18938997.83097.83
6182388-18238894.21394.21
10min1190912-19091298.61699.691.2898.7899.841.28
2194149-194149100.288100.44
3189738-18973898.01098.17
4192060-19206099.20999.36
5195981-195981101.235101.40
6195059-195059100.758100.92
15min1192248-19224899.306100.331.1999.63100.651.18
2196083-196083101.287101.61
3190882-19088298.60198.92
4194071-194071100.248100.57
5196782-196782101.648101.98
6195311-195311100.889101.21
20min1191694-19169499.020100.511.2699.51101.001.26
2197668-197668102.106102.60
3191865-19186599.10899.59
4194331-194331100.382100.87
5196654-196654101.582102.08
6195215-195215100.839101.33
30min1192293-19229399.330100.861.4799.98101.521.47
2199087-199087102.839103.50
3191683-19168399.01499.66
4195659-195659101.068101.72
5197347-197347101.940102.61
6195488-195488100.980101.64
45min1192263-19226399.314100.871.49100.13101.701.49
2199320-199320102.959103.79
3191899-19189999.12699.94
4195442-195442100.956101.78
5197546-197546102.043102.88
6195211-195211100.837101.67
极限1192154-19215499.258100.591.54100.24101.591.54
2199259-199259102.928103.93
3191169-19116998.74999.73
4194869-194869100.660101.65
5196889-196889101.704102.71
6194103-194103100.265101.26
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.561936371934891932501933151934971934380.09
219.491922381922651922520.01
单位质量响应值RSD%判断
9889.479864.140.19数据可信
供试品溶液-2025042221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%
5min1185961-18596196.17593.332.5496.1893.342.54
2178810-17881092.47792.48
3185023-18502395.69095.69
4180089-18008993.13893.14
5179504-17950492.83692.84
6173405-17340589.68289.68
10min1196008-196008101.37199.950.90101.53100.110.90
2191445-19144599.01199.17
3194581-194581100.633100.79
4191887-19188799.24099.40
5193193-19319399.916100.07
6192463-19246399.53899.69
15min1197700-197700102.246100.640.88102.58100.970.89
2194022-194022100.344100.66
3194876-194876100.786101.11
4193056-19305699.845100.17
5194822-194822100.758101.08
6193133-19313399.884100.20
20min1198125-198125102.466100.850.85102.97101.340.86
2194395-194395100.537101.02
3195126-195126100.915101.41
4193655-193655100.154100.64
5195014-195014100.857101.35
6193674-193674100.164100.65
30min1198477-198477102.648101.100.84103.32101.750.84
2194443-194443100.562101.22
3195273-195273100.991101.65
4194036-194036100.351101.01
5196078-196078101.408102.06
6194546-194546100.615101.26
45min1198325-198325102.570101.070.84103.41101.900.84
2193997-193997100.331101.15
3195232-195232100.970101.80
4195099-195099100.901101.72
5196035-196035101.385102.21
6193888-193888100.275101.09
极限1197999-197999102.401100.770.87103.41101.760.87
2193503-193503100.076101.06
3194070-194070100.369101.37
4194524-194524100.604101.59
5195305-195305101.008102.00
6193626-193626100.139101.12
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