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%
119.402041182042352041182040582039092040880.06
219.432042772046292044530.13
单位质量响应值RSD%判断
10520.0010522.540.02数据可信
供试品溶液-2025032621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%
5min1186968-18696890.77390.025.1690.7790.025.16
2178283-17828386.55686.56
3199115-19911596.67096.67
4174896-17489684.91284.91
5193776-19377694.07894.08
6179529-17952987.16187.16
10min1204288-20428899.18297.712.4899.3397.862.48
2201970-20197098.05698.20
3204030-20403099.05699.22
4191402-19140292.92693.07
5204417-20441799.24499.40
6201475-20147597.81697.96
15min1205727-20572799.88098.652.04100.2098.962.05
2203877-20387798.98299.29
3204232-20423299.15599.48
4194847-19484794.59894.89
5205279-20527999.66399.99
6205168-20516899.60999.92
20min1206051-206051100.03898.962.01100.5299.432.01
2204268-20426899.17299.64
3204411-20441199.24199.73
4195707-19570795.01695.47
5206165-206165100.093100.58
6206354-206354100.185100.66
30min1206046-206046100.03599.221.92100.6999.861.92
2205126-20512699.589100.23
3203928-20392899.00799.66
4196864-19686495.57796.19
5206303-206303100.160100.82
6207920-207920100.945101.59
45min1205993-205993100.01099.211.94100.83100.021.94
2204915-20491599.486100.29
3203848-20384898.96899.79
4196841-19684195.56696.34
5206119-206119100.071100.89
6208315-208315101.137101.95
极限1205459-20545999.75099.081.92100.73100.061.92
2204772-20477299.417100.39
3203245-20324598.67599.66
4196861-19686195.57696.51
5205876-20587699.953100.94
6208315-208315101.137102.11
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%
119.402041972040442038122038292040962039960.09
219.432040032039152039590.04
单位质量响应值RSD%判断
10515.2610497.120.13数据可信
供试品溶液-2025032621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%
5min1197381-19738195.96693.995.1895.9793.995.19
2204943-20494399.64399.64
3197907-19790796.22296.22
4197776-19777696.15896.16
5179783-17978387.41087.41
6182115-18211588.54488.54
10min1205005-20500599.673100.071.8799.83100.221.87
2211815-211815102.984103.15
3207631-207631100.950101.11
4206405-206405100.353100.51
5203544-20354498.96299.11
6200500-20050097.48397.63
15min1205177-20517799.756100.321.52100.08100.651.52
2211621-211621102.889103.23
3207504-207504100.888101.22
4205919-205919100.117100.44
5205725-205725100.023100.33
6202131-20213198.27598.59
20min1205454-20545499.891100.381.53100.38100.871.54
2211698-211698102.927103.44
3207505-207505100.888101.39
4206112-206112100.211100.71
5205979-205979100.146100.62
6202031-20203198.22798.70
30min1205267-20526799.800100.261.38100.46100.921.39
2210726-210726102.454103.14
3207496-207496100.884101.55
4205849-205849100.083100.74
5205844-205844100.081100.72
6202078-20207898.25098.89
45min1204896-20489699.620100.051.38100.44100.881.38
2210633-210633102.409103.26
3206553-206553100.425101.26
4205184-20518499.760100.59
5205476-20547699.902100.71
6201944-20194498.18598.99
极限1203821-20382199.09799.701.45100.09100.691.46
2209806-209806102.007103.03
3206052-206052100.182101.18
4204637-20463799.494100.49
5205266-20526699.800100.78
6200733-20073397.59698.56
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%
119.402039512037702037212036212037242037570.06
219.432036932039202038060.08
单位质量响应值RSD%判断
10502.9410489.240.10数据可信
供试品溶液-2025032621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%
5min1196765-19676595.75992.269.1595.7692.269.15
2191449-19144993.17193.17
3155590-15559075.72075.72
4205042-20504299.78799.79
5192098-19209893.48793.49
6196463-19646395.61295.61
10min1204141-20414199.348100.902.5899.51101.062.58
2212854-212854103.588103.74
3204508-20450899.52799.65
4214992-214992104.629104.80
5201546-20154698.08598.24
6205988-205988100.247100.41
15min1205233-20523399.880101.432.47100.20101.762.47
2213689-213689103.995104.32
3207071-207071100.774101.07
4215655-215655104.952105.29
5202444-20244498.52298.84
6206464-206464100.479100.81
20min1203680-20368099.124101.272.5199.62101.762.51
2213095-213095103.706104.21
3207724-207724101.092101.55
4215520-215520104.886105.40
5202502-20250298.55199.03
6205976-205976100.241100.74
30min1204202-20420299.378101.272.46100.03101.932.46
2212828-212828103.576104.25
3208182-208182101.315101.94
4215231-215231104.745105.44
5201906-20190698.26098.91
6206215-206215100.358101.02
45min1203803-20380399.184100.982.45100.01101.812.45
2212255-212255103.297104.14
3207340-207340100.905101.70
4214627-214627104.451105.32
5201388-20138898.00898.82
6205519-205519100.019100.85
极限1203654-20365499.111100.912.43100.10101.912.43
2212409-212409103.372104.39
3207767-207767101.113102.08
4214005-214005104.149105.19
5201244-20124497.93898.91
6205066-20506699.798100.79
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%
119.402038802037202040532042582040382039900.10
219.432041042043152042100.08
单位质量响应值RSD%判断
10514.9510510.040.04数据可信
供试品溶液-2025032621批-pH1.1
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1193733-19373394.13693.234.0194.1493.224.01
2178316-17831686.64586.64
3193441-19344193.99493.99
4201406-20140697.86497.86
5189499-18949992.07992.08
6194778-19477894.64494.64
10min1203357-20335798.81299.531.6998.9799.681.69
2202192-20219298.24698.39
3202517-20251798.40498.56
4207682-207682100.914101.08
5210526-210526102.296102.45
6202707-20270798.49698.65
15min1203634-20363498.94799.711.7999.27100.031.78
2202904-20290498.59298.90
3202611-20261198.45098.77
4208270-208270101.199101.53
5211202-211202102.624102.95
6202583-20258398.43698.76
20min1202715-20271598.50099.441.8598.9999.931.84
2202879-20287998.58099.05
3202119-20211998.21198.70
4207906-207906101.023101.52
5210775-210775102.417102.91
6201542-20154297.93098.42
30min1202764-20276498.52499.431.8699.17100.081.86
2202781-20278198.53299.17
3201667-20166797.99198.64
4207810-207810100.976101.64
5210857-210857102.456103.12
6201878-20187898.09498.74
45min1202224-20222498.26299.171.9799.0899.991.97
2201718-20171898.01698.82
3201288-20128897.80798.62
4207407-207407100.780101.62
5210720-210720102.390103.23
6201149-20114997.73998.55
极限1202160-20216098.23199.041.8499.21100.021.84
2201797-20179798.05499.02
3201255-20125597.79198.77
4207034-207034100.599101.60
5209908-209908101.995103.00
6200744-20074497.54398.52
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