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2000
标示量(mg)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%
119.561901931900841897731894961893111897710.20
219.491878521888051883280.36
单位质量响应值RSD%判断
9701.999662.800.29数据可信
供试品溶液-2025042021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%
5min1183525-18352596.82193.216.0296.8293.216.02
2185347-18534797.78397.78
3161746-16174685.33285.33
4165185-16518587.14687.15
5185896-18589698.07298.07
6178416-17841694.12694.13
10min1189834-189834100.150100.521.20100.31100.671.20
2193339-193339101.999102.16
3190370-190370100.433100.57
4186623-18662398.45698.60
5191806-191806101.190101.35
6191222-191222100.882101.04
15min1189818-189818100.141101.101.32100.47101.431.31
2193981-193981102.338102.67
3194062-194062102.380102.69
4187761-18776199.05699.37
5191254-191254100.899101.23
6192971-192971101.805102.13
20min1189879-189879100.174101.060.74100.67101.550.74
2192770-192770101.699102.20
3191612-191612101.088101.57
4189821-189821100.143100.62
5193011-193011101.826102.33
6192217-192217101.407101.90
30min1187952-18795299.157100.981.2999.82101.641.29
2193784-193784102.234102.91
3193446-193446102.055102.70
4189009-18900999.715100.36
5191152-191152100.845101.52
6193115-193115101.881102.54
45min1188858-18885899.635100.700.88100.46101.530.87
2192790-192790101.709102.55
3192854-192854101.743102.56
4189575-189575100.013100.82
5190184-190184100.334101.17
6190997-190997100.763101.60
极限1187391-18739198.861100.451.1499.85101.441.13
2192618-192618101.619102.63
3192620-192620101.620102.61
4188589-18858999.493100.47
5189921-189921100.196101.20
6191266-191266100.905101.91
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2000
标示量(mg)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%
119.561885381887941885141877311885861884330.22
219.491873761877441875600.14
单位质量响应值RSD%判断
9633.599623.400.08数据可信
供试品溶液-2025042021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%
5min1183821-18382197.52090.384.7997.5290.384.79
2168439-16843989.36089.36
3176259-17625993.50893.51
4166679-16667988.42688.43
5164986-16498687.52887.53
6161986-16198685.93685.94
10min1190115-190115100.85999.431.66101.0299.581.66
2186491-18649198.93799.09
3191110-191110101.387101.54
4185977-18597798.66498.81
5188278-18827899.885100.03
6182548-18254896.84596.99
15min1190680-190680101.159100.191.49101.49100.511.49
2188888-188888100.208100.52
3192477-192477102.112102.44
4187307-18730799.36999.68
5189398-189398100.479100.79
6184390-18439097.82298.13
20min1189924-189924100.758100.031.17101.26100.511.17
2188048-18804899.763100.24
3191824-191824101.766102.26
4188006-18800699.740100.22
5188209-18820999.848100.33
6185279-18527998.29498.76
30min1190868-190868101.259100.261.55101.93100.911.55
2189852-189852100.720101.37
3192522-192522102.136102.80
4188387-18838799.942100.59
5188271-18827199.881100.53
6184006-18400697.61898.25
45min1190282-190282100.94899.901.78101.78100.721.77
2187849-18784999.657100.47
3193194-193194102.493103.33
4186930-18693099.16999.98
5188361-18836199.929100.74
6183243-18324397.21398.01
极限1189941-189941100.76799.591.76101.77100.571.75
2186197-18619798.78199.76
3190907-190907101.279102.28
4186177-18617798.77099.75
5190531-190531101.080102.06
6182591-18259196.86897.82
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2000
标示量(mg)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%
119.561872351873731863121880041873481872540.33
219.491876541875361875950.05
单位质量响应值RSD%判断
9573.319625.190.39数据可信
供试品溶液-2025042121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%
5min1159173-15917384.70289.023.7084.7089.023.70
2162131-16213186.27686.28
3175610-17561093.44893.45
4165948-16594888.30788.31
5172441-17244191.76291.76
6168426-16842689.62689.63
10min1180812-18081296.21798.721.8596.3698.871.84
2184478-18447898.16798.31
3186116-18611699.03999.19
4190377-190377101.307101.45
5183289-18328997.53597.69
6188013-188013100.049100.20
15min1182495-18249597.11299.601.5497.4199.911.54
2187003-18700399.51199.82
3188242-188242100.170100.49
4190943-190943101.608101.92
5185704-18570498.82099.14
6188584-188584100.352100.67
20min1182292-18229297.00499.811.8197.47100.291.81
2187508-18750899.780100.25
3188566-188566100.343100.83
4192132-192132102.240102.73
5185470-18547098.69599.18
6189408-189408100.791101.27
30min1182760-18276097.25399.461.4497.88100.111.44
2187414-18741499.730100.37
3186809-18680999.408100.06
4189819-189819101.010101.67
5185174-18517498.53899.18
6189520-189520100.850101.50
45min1182733-18273397.23999.221.5098.03100.031.50
2185357-18535798.63599.44
3187917-18791799.997100.82
4190640-190640101.446102.27
5184637-18463798.25299.06
6187450-18745099.749100.57
极限1181834-18183496.76099.031.2797.71100.011.27
2188104-188104100.097101.07
3186543-18654399.266100.25
4187824-18782499.948100.94
5185128-18512898.51399.49
6187176-18717699.603100.59
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2000
标示量(mg)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%
119.561875291865331870621869551877761871710.27
219.491856891850651853770.24
单位质量响应值RSD%判断
9569.079511.390.43数据可信
供试品溶液-2025042121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%
5min1177421-17742194.99691.286.8295.0091.286.83
2163200-16320087.38287.38
3150316-15031680.48480.48
4177226-17722694.89294.89
5173566-17356692.93292.93
6181099-18109996.96696.97
10min1188617-188617100.99199.732.17101.1599.882.18
2181541-18154197.20297.35
3182667-18266797.80597.94
4188956-188956101.173101.33
5184140-18414098.59498.75
6191629-191629102.604102.77
15min1189194-189194101.300100.341.92101.63100.651.92
2182504-18250497.71898.03
3185390-18539099.26399.56
4189897-189897101.676102.00
5185245-18524599.18699.50
6192122-192122102.868103.20
20min1188892-188892101.138100.412.54101.63100.892.54
2181953-18195397.42397.89
3184955-18495599.03099.49
4189610-189610101.523102.02
5184473-18447398.77299.26
6195268-195268104.552105.06
30min1187670-187670100.484100.151.87101.15100.811.88
2183294-18329498.14198.77
3184974-18497499.04199.67
4190327-190327101.907102.57
5184181-18418198.61699.27
6191884-191884102.740103.42
45min1186354-18635499.77999.922.04100.61100.742.05
2181531-18153197.19797.99
3184979-18497999.04399.84
4190392-190392101.941102.78
5184703-18470398.89599.71
6191701-191701102.642103.49
极限1187683-187683100.49199.872.03101.49100.862.03
2182279-18227997.59898.56
3185202-18520299.163100.12
4187889-187889100.601101.61
5183401-18340198.19899.18
6192721-192721103.188104.21
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