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%
119.261907321909211910451910981911201909830.09
219.171908491910951909720.10
单位质量响应值RSD%判断
9916.049962.020.33数据可信
供试品溶液-2025042021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%
5min1178768-17876891.87791.605.4091.8891.605.40
2166469-16646985.55685.56
3188586-18858696.92396.92
4167654-16765486.16586.16
5188415-18841596.83596.83
6179528-17952892.26792.27
10min1191668-19166898.50697.971.5598.6698.121.55
2185097-18509795.12995.27
3192934-19293499.15799.32
4189624-18962497.45697.60
5192126-19212698.74298.90
6192325-19232598.84499.00
15min1193576-19357699.48798.811.1599.8099.121.15
2187842-18784296.54096.84
3193563-19356399.48099.81
4192966-19296699.17499.48
5192517-19251798.94399.27
6193074-19307499.22999.55
20min1194197-19419799.80699.141.04100.2999.621.04
2189169-18916997.22297.68
3193349-19334999.37099.86
4194534-19453499.979100.45
5192312-19231298.83799.33
6193863-19386399.635100.12
30min1195713-195713100.58599.461.23101.23100.111.22
2189504-18950497.39498.02
3193766-19376699.585100.24
4195791-195791100.625101.26
5192291-19229198.82799.48
6194109-19410999.761100.41
45min1195448-195448100.44999.481.26101.27100.301.26
2189749-18974997.52098.31
3193890-19389099.648100.47
4196404-196404100.941101.75
5191858-19185898.60499.42
6194054-19405499.733100.55
极限1195734-195734100.59699.341.26101.58100.321.26
2189407-18940797.34498.29
3193515-19351599.456100.45
4195655-195655100.556101.53
5191666-19166698.50599.49
6193780-19378099.592100.57
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%
119.261907781910221911561914131909241910590.13
219.171907561908451908000.04
单位质量响应值RSD%判断
9919.999953.050.24数据可信
供试品溶液-2025042021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%
5min1190988-19098898.18292.373.7798.1892.363.77
2174457-17445789.68389.68
3173536-17353689.21089.21
4182206-18220693.66793.67
5182085-18208593.60593.60
6174771-17477189.84589.84
10min1195746-195746100.62898.422.21100.7998.582.21
2188236-18823696.76796.92
3192747-19274799.08699.23
4191713-19171398.55498.71
5195404-195404100.452100.61
6184876-18487695.04095.19
15min1196323-196323100.92499.122.21101.2699.442.21
2190143-19014397.74798.06
3194682-194682100.081100.39
4193217-19321799.32799.65
5196874-196874101.207101.53
6185697-18569795.46295.77
20min1196350-196350100.93899.412.11101.4499.892.11
2190929-19092998.15198.62
3194679-194679100.079100.56
4193894-19389499.675100.16
5197820-197820101.694102.19
6186585-18658595.91896.39
30min1196019-196019100.76899.571.91101.44100.221.91
2192105-19210598.75699.39
3194825-194825100.154100.80
4194473-19447399.973100.63
5197575-197575101.568102.23
6187120-18712096.19396.82
45min1196346-196346100.93699.571.98101.77100.391.98
2192508-19250898.96399.76
3194507-19450799.991100.80
4194251-19425199.859100.68
5197749-197749101.657102.49
6186798-18679896.02896.82
极限1196266-196266100.89599.431.95101.90100.411.95
2192304-19230498.85899.82
3194539-194539100.007100.99
4193683-19368399.567100.55
5197067-197067101.307102.31
6186588-18658895.92096.87
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%
119.261909671907341910171905991906751907980.10
219.171900381900501900440.01
单位质量响应值RSD%判断
9906.449913.620.06数据可信
供试品溶液-2025042121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%
5min1184516-18451695.10892.432.9395.1192.432.93
2178919-17891992.22392.22
3169934-16993487.59287.59
4183517-18351794.59394.59
5178020-17802091.76091.76
6181045-18104593.31993.32
10min1190444-19044498.16397.451.7498.3297.601.74
2187860-18786096.83296.99
3183619-18361994.64694.79
4193510-19351099.74499.90
5188818-18881897.32597.48
6190090-19009097.98198.14
15min1190538-19053898.21297.931.5198.5398.241.51
2188275-18827597.04597.36
3185489-18548995.60995.91
4193964-19396499.978100.30
5190887-19088798.39298.71
6190792-19079298.34398.66
20min1190306-19030698.09298.181.4398.5898.661.43
2188699-18869997.26497.74
3186267-18626796.01096.47
4193991-19399199.992100.48
5191807-19180798.86699.35
6191805-19180598.86599.35
30min1191473-19147398.69498.521.2799.3499.161.27
2190195-19019598.03598.67
3186892-18689296.33396.96
4193963-19396399.977100.63
5192257-19225799.09899.74
6192014-19201498.97399.62
45min1190404-19040498.14398.421.1198.9699.231.11
2188299-18829997.05897.86
3188869-18886997.35298.14
4193600-19360099.790100.61
5192079-19207999.00699.82
6192433-19243399.189100.00
极限1190042-19004297.95697.751.9098.9398.721.90
2188512-18851297.16898.13
3183005-18300594.32995.27
4192851-19285199.404100.39
5191810-19181098.86899.84
6191642-19164298.78199.76
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%
119.261899741904071901901901661901601901790.09
219.171894411899351896880.19
单位质量响应值RSD%判断
9874.309895.040.15数据可信
供试品溶液-2025042121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%
5min1185300-18530095.75792.932.4895.7692.932.48
2177892-17789291.92991.93
3172735-17273589.26489.26
4183665-18366594.91294.91
5179748-17974892.88892.89
6179614-17961492.81992.82
10min1192431-19243199.44298.231.1399.6098.391.12
2186717-18671796.48996.64
3191369-19136998.89399.04
4190797-19079798.59898.76
5190886-19088698.64498.80
6188346-18834697.33197.49
15min1193923-193923100.21399.031.38100.5499.351.38
2187371-18737196.82797.14
3193525-193525100.007100.32
4193187-19318799.833100.16
5192397-19239799.42599.74
6189440-18944097.89698.21
20min1193973-193973100.23999.191.34100.7399.671.34
2187549-18754996.91997.39
3193933-193933100.218100.70
4193677-193677100.086100.57
5192121-19212199.28299.77
6190359-19035998.37198.85
30min1193480-19348099.98499.351.33100.64100.001.32
2188197-18819797.25497.89
3195070-195070100.806101.45
4194032-194032100.269100.93
5192279-19227999.364100.01
6190466-19046698.42799.07
45min1194570-194570100.54799.421.35101.37100.231.34
2187773-18777397.03597.83
3194119-194119100.314101.13
4194010-194010100.258101.08
5192637-19263799.549100.36
6191167-19116798.78999.60
极限1194543-194543100.53499.071.58101.53100.051.58
2186803-18680396.53497.49
3194106-194106100.308101.29
4193192-19319299.835100.83
5192263-19226399.355100.34
6189364-18936497.85798.83
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