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%
119.592013932014532017822017252018522016410.11
219.482016842016642016740.01
单位质量响应值RSD%判断
10293.0610352.870.41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%
5min1189531-18953193.78691.199.5393.7991.199.53
2193371-19337195.68695.69
3149538-14953873.99674.00
4193145-19314595.57495.57
5196345-19634597.15797.16
6183765-18376590.93290.93
10min1203439-203439100.668101.002.95100.82101.152.96
2205622-205622101.748101.91
3195100-19510096.54196.66
4211494-211494104.654104.81
5209105-209105103.471103.63
6199942-19994298.93799.09
15min1205263-205263101.570101.732.58101.89102.052.59
2207092-207092102.475102.80
3198581-19858198.26498.55
4211550-211550104.681105.02
5210647-210647104.235104.57
6200330-20033099.12999.45
20min1205875-205875101.873102.242.39102.37102.732.40
2208068-208068102.958103.46
3201072-20107299.49799.94
4212622-212622105.212105.72
5211115-211115104.466104.97
6200987-20098799.45499.94
30min1206270-206270102.069102.602.11102.73103.262.12
2208486-208486103.165103.84
3202400-202400100.154100.77
4212455-212455105.129105.81
5211820-211820104.815105.50
6202618-202618100.262100.91
45min1206407-206407102.136102.582.13102.97103.412.14
2208381-208381103.113103.96
3202186-202186100.048100.83
4212210-212210105.008105.87
5212055-212055104.931105.79
6202549-202549100.227101.04
极限1205563-205563101.719102.302.06102.72103.302.07
2208082-208082102.965103.98
3201644-20164499.780100.73
4211841-211841104.825105.86
5210791-210791104.306105.34
6202450-202450100.178101.16
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%
119.592022782018722019792016282016702018850.14
219.482021902025032023460.11
单位质量响应值RSD%判断
10305.5110387.370.56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%
5min1195138-19513896.34289.3213.8596.3489.3213.85
2132224-13222465.28065.28
3195089-19508996.31896.32
4193873-19387395.71795.72
5193724-19372495.64495.64
6175464-17546486.62986.63
10min1210953-210953104.150100.083.92104.31100.233.93
2187721-18772192.68092.79
3205624-205624101.519101.68
4205632-205632101.523101.68
5204681-204681101.053101.21
6201626-20162699.54599.69
15min1212858-212858105.090101.213.20105.42101.533.22
2192925-19292595.24995.51
3206518-206518101.960102.29
4206834-206834102.116102.44
5206131-206131101.769102.10
6204772-204772101.098101.41
20min1212415-212415104.872101.502.83105.38101.982.85
2194816-19481696.18396.60
3206966-206966102.181102.68
4207413-207413102.402102.90
5206203-206203101.805102.30
6205739-205739101.576102.05
30min1212646-212646104.986101.852.54105.67102.502.56
2196651-19665197.08997.67
3207084-207084102.240102.91
4208002-208002102.693103.36
5206710-206710102.055102.72
6206711-206711102.056102.70
45min1213433-213433105.374101.952.61106.23102.782.62
2196862-19686297.19397.94
3206784-206784102.092102.93
4207786-207786102.586103.43
5206381-206381101.893102.73
6207796-207796102.591103.41
极限1214286-214286105.795101.812.62106.83102.802.64
2197338-19733897.42898.33
3206473-206473101.938102.95
4207248-207248102.321103.33
5205874-205874101.642102.65
6206024-206024101.716102.71
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%
119.591014661012991014961015711014761014620.10
219.481017031015351016190.12
单位质量响应值RSD%判断
5179.285216.580.51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%
5min1100076-10007698.34798.812.8798.3598.822.87
2103508-103508101.720101.72
3100068-10006898.33998.34
4101695-10169599.93899.94
595363-9536393.71693.72
6102589-102589100.817100.82
10min1100942-10094299.19899.272.9599.3699.432.95
2104602-104602102.795102.96
399099-9909997.38797.55
4102012-102012100.250100.42
596301-9630194.63794.79
6103118-103118101.337101.50
15min1100993-10099399.24899.262.9099.5899.592.90
2104268-104268102.467102.81
399067-9906797.35697.68
4101992-101992100.230100.56
596345-9634594.68194.99
6103378-103378101.592101.93
20min1101250-10125099.50199.382.66100.0099.882.66
2104192-104192102.392102.90
399417-9941797.70098.19
4102275-102275100.508101.01
596746-9674695.07595.55
6102899-102899101.122101.63
30min1100940-10094099.19699.202.7499.8699.862.73
2104003-104003102.206102.89
399579-9957997.85998.51
4101895-101895100.135100.80
596268-9626894.60595.24
6102947-102947101.169101.84
45min1100577-10057798.84099.032.8199.6799.862.82
2104265-104265102.464103.32
399055-9905597.34498.16
4101769-101769100.011100.85
596280-9628094.61795.40
6102695-102695100.921101.76
极限199687-9968797.96598.712.8398.9699.702.83
2104174-104174102.374103.40
399337-9933797.62198.60
4101450-10145099.698100.70
595895-9589594.23995.18
6102122-102122100.358101.37
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%
119.591011261009041010101009791010241010090.08
219.481014811010711012760.29
单位质量响应值RSD%判断
5156.155198.970.59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%
5min1101429-101429100.06998.711.16100.0798.711.16
298044-9804496.73096.73
3100760-10076099.40999.41
4100437-10043799.09199.09
599843-9984398.50598.50
699814-9981498.47698.48
10min1102268-102268100.897100.290.68101.06100.460.68
2100483-10048399.13699.30
3101617-101617100.255100.42
4101505-101505100.144100.31
5101637-101637100.275100.44
6102430-102430101.057101.22
15min1102672-102672101.29699.861.16101.63100.201.16
299125-9912597.79698.12
3101566-101566100.205100.54
4101474-101474100.114100.45
5101555-101555100.194100.53
6100922-10092299.56999.90
20min1102641-102641101.26599.561.28101.77100.061.28
298792-9879297.46897.96
3101340-10134099.982100.48
4100837-10083799.48599.98
5101471-101471100.111100.61
6100393-10039399.04799.55
30min1101952-101952100.58599.201.10101.2699.861.10
298610-9861097.28897.94
3100652-10065299.30399.97
4100832-10083299.480100.15
5100960-10096099.607100.27
6100265-10026598.92199.58
45min1102314-102314100.94398.981.39101.7899.811.38
297969-9796996.65697.47
3100446-10044699.10099.93
4100362-10036299.01799.85
5100606-10060699.257100.09
6100265-10026598.92199.75
极限1102453-102453101.08099.031.37102.09100.021.37
298246-9824696.92997.90
3100684-10068499.334100.33
4100481-10048199.134100.13
5100655-10065599.306100.30
699738-9973898.40199.39
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