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%
119.642056962051922051832048882050912052100.15
219.702048772050842049800.08
单位质量响应值RSD%判断
10448.5710405.080.30数据可信
供试品溶液-25031102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%
5min1168970-16897082.77885.673.6282.7885.683.62
2184478-18447890.37690.38
3174796-17479685.63285.63
4167172-16717281.89781.90
5175445-17544585.95085.95
6178416-17841687.40687.41
10min1201351-20135198.64296.942.7098.7897.092.70
2202024-20202498.97199.12
3201967-20196798.94499.09
4188940-18894092.56292.70
5199055-19905597.51797.66
6193985-19398595.03395.18
15min1203227-20322799.56197.722.4399.8698.022.43
2202750-20275099.32799.64
3203278-20327899.58699.89
4191512-19151293.82294.11
5200311-20031198.13298.44
6195725-19572595.88696.19
20min1201659-20165998.79397.522.2199.2697.992.21
2201933-20193398.92799.41
3202990-20299099.44599.92
4191206-19120693.67294.12
5199534-19953497.75298.22
6197062-19706296.54197.00
30min1203483-20348399.68697.952.35100.3298.582.36
2202081-20208198.99999.65
3203901-20390199.891100.53
4191531-19153193.83194.43
5201035-20103598.48799.12
6197581-19758196.79597.42
45min1203279-20327999.58697.872.27100.3998.672.27
2201202-20120298.56999.38
3203846-20384699.864100.67
4191543-19154393.83794.60
5200735-20073598.34099.14
6198108-19810897.05397.84
极限1204266-204266100.07098.262.33101.0399.222.33
2201771-20177198.84799.82
3204680-204680100.273101.24
4191825-19182593.97594.89
5201022-20102298.48199.44
6199894-19989497.92898.88
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%
119.642047232049662038372039742047182044440.25
219.702046142033352039740.45
单位质量响应值RSD%判断
10409.5710354.010.38数据可信
供试品溶液-25031102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%
5min1175038-17503886.12381.199.7586.1281.189.75
2151821-15182174.70074.70
3176372-17637286.78086.78
4164086-16408680.73580.73
5140602-14060269.18069.18
6182107-18210789.60189.60
10min1198346-19834697.59197.362.9697.7397.492.96
2187065-18706592.04192.17
3204061-204061100.403100.55
4198565-19856597.69997.83
5197457-19745797.15497.27
6201748-20174899.26599.41
15min1198798-19879897.81498.532.6698.1298.832.67
2190921-19092193.93894.22
3206698-206698101.701102.01
4201677-20167799.23099.53
5200162-20016298.48598.76
6203251-203251100.005100.32
20min1199054-19905497.94098.552.2598.4199.022.26
2192104-19210494.52094.95
3204985-204985100.858101.34
4201701-20170199.24299.70
5200772-20077298.78599.23
6203197-20319799.978100.46
30min1198031-19803197.43698.492.1998.0799.122.19
2192458-19245894.69495.29
3204486-204486100.612101.26
4202716-20271699.742100.37
5200753-20075398.77699.38
6202587-20258799.678100.33
45min1197347-19734797.10098.532.0697.8999.322.07
2193432-19343295.17495.92
3204737-204737100.736101.55
4202405-20240599.588100.38
5201382-20138299.08599.86
6202249-20224999.512100.33
极限1197819-19781997.33298.561.8998.2999.511.90
2193914-19391495.41196.32
3203891-203891100.320101.30
4203209-20320999.984100.94
5201144-20114498.96899.90
6201859-20185999.320100.30
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%
119.642054422040172046002052282047592048090.28
219.702038132038082038100.01
单位质量响应值RSD%判断
10428.1610345.690.57数据可信
供试品溶液-25031102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%
5min1171303-17130384.24586.724.9684.2486.724.96
2188404-18840492.65592.65
3173708-17370885.42785.43
4181374-18137489.19789.20
5163414-16341480.36580.36
6179765-17976588.40688.41
10min1193996-19399695.40596.791.8995.5596.931.89
2201194-20119498.94599.10
3198859-19885997.79697.94
4200092-20009298.40398.55
5192199-19219994.52194.65
6194484-19448495.64595.79
15min1194820-19482095.81097.541.5196.1197.851.51
2202674-20267499.67299.99
3200004-20000498.35998.66
4199824-19982498.27198.58
5196989-19698996.87797.17
6195771-19577196.27896.58
20min1195392-19539296.09197.881.4496.5598.351.44
2203211-20321199.937100.42
3200326-20032698.51898.99
4200474-20047498.59199.07
5198036-19803697.39297.84
6196732-19673296.75097.22
30min1195468-19546896.12998.201.4596.7598.831.45
2204166-204166100.406101.06
3200857-20085798.77999.41
4199722-19972298.22198.86
5199625-19962598.17398.79
6198215-19821597.48098.11
45min1196866-19686696.81698.761.4797.6099.561.47
2205477-205477101.051101.87
3202387-20238799.531100.33
4199992-19999298.35399.16
5201097-20109798.89799.68
6199139-19913997.93498.72
极限1196424-19642496.59998.721.3697.5499.681.36
2204590-204590100.615101.60
3201883-20188399.283100.25
4199823-19982398.27099.24
5201595-20159599.142100.09
6200067-20006798.39099.34
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