非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.182001957200172720046182002975200046920023490.08
210.302066679206625120664650.02
单位质量响应值RSD%判断
196694.40200627.671.40数据可信
加速6月-供试品溶液-2024112321(均一性1)批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1885000-88500040.05739.549.2240.0639.549.22
2804957-80495736.43436.43
3922246-92224641.74341.74
4999235-99923545.22845.23
5850648-85064838.50238.50
6779511-77951135.28335.28
10min11612153-161215372.97073.991.9673.0674.081.97
21606772-160677272.72672.81
31641170-164117074.28374.38
41694477-169447776.69676.80
51620388-162038873.34373.43
61632656-163265673.89873.98
15min11876366-187636684.92985.120.8185.1885.370.82
21855776-185577683.99784.24
31902843-190284386.12786.39
41884571-188457185.30085.57
51881351-188135185.15585.40
61882700-188270085.21685.46
20min11970463-197046389.18889.530.8789.6389.970.88
21965238-196523888.95189.38
31980168-198016889.62790.08
42007067-200706790.84591.31
51985338-198533889.86190.30
61959637-195963788.69889.13
30min12056283-205628393.07293.360.6993.7194.000.70
22047341-204734192.66893.29
32074671-207467193.90594.55
42084697-208469794.35895.02
52060655-206065593.27093.91
62052802-205280292.91593.54
45min12085730-208573094.40594.950.7195.2595.800.71
22082839-208283994.27495.11
32102790-210279095.17796.03
42123406-212340696.11196.98
52100015-210001595.05295.90
62092117-209211794.69495.53
60min12099447-209944795.02695.400.5296.0896.460.53
22099914-209991495.04796.09
32116126-211612695.78196.85
42125055-212505596.18597.27
52107769-210776995.40396.46
62098280-209828094.97396.02
极限12103882-210388295.22795.630.4896.4996.900.48
22104775-210477595.26796.52
32110678-211067895.53496.82
42130584-213058496.43597.73
52116992-211699295.82097.09
62109209-210920995.46896.72
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.182014520201253220129762014888201315620136140.06
210.302068793206867220687320.01
单位质量响应值RSD%判断
197800.98200847.771.09数据可信
加速6月-供试品溶液-2024112321(均一性2)批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1733150-73315033.07239.7912.8433.0739.7912.84
2957743-95774343.20443.20
3753756-75375634.00234.00
41012337-101233745.66745.67
5908189-90818940.96840.97
6927614-92761441.84541.84
10min11560423-156042370.39173.743.4170.4673.833.42
21661884-166188474.96875.06
31571263-157126370.88070.96
41697184-169718476.56076.66
51667817-166781775.23575.33
61649220-164922074.39674.49
15min11836658-183665882.85284.621.5783.0884.871.59
21879274-187927484.77485.04
31848114-184811483.36883.60
41910501-191050186.18386.45
51904425-190442585.90986.17
61876162-187616284.63484.89
20min11939400-193940087.48688.780.9387.9089.220.95
21973134-197313489.00889.46
31954329-195432988.16088.58
41986278-198627889.60190.06
51985432-198543289.56390.01
61969933-196993388.86489.31
30min12035801-203580191.83592.441.1292.4493.081.13
22040537-204053792.04992.70
32015488-201548890.91991.53
42075472-207547293.62594.29
52070196-207019693.38794.03
62057460-205746092.81293.46
45min12061906-206190693.01394.081.0393.8394.921.04
22067160-206716093.25094.10
32073835-207383593.55194.37
42100489-210048994.75395.62
52116699-211669995.48496.34
62093399-209339994.43395.28
60min12076004-207600493.64994.871.0494.6795.921.05
22113567-211356795.34396.40
32090399-209039994.29895.32
42138597-213859796.47297.55
52106033-210603395.00396.07
62094329-209432994.47595.54
极限12082334-208233493.93494.840.7995.1696.100.80
22101507-210150794.79996.07
32084999-208499994.05495.29
42122871-212287195.76397.06
52116736-211673695.48696.76
62106183-210618395.01096.28
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.182077139207781520774582076930207712520772930.02
210.302096474209682320966480.02
单位质量响应值RSD%判断
204056.29203558.060.18数据可信
加速6月-供试品溶液-2024112421(均一性1)批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1970632-97063242.82045.275.8042.8245.275.80
21016431-101643144.84044.84
31049839-104983946.31446.31
41133791-113379150.01850.02
51003462-100346244.26844.27
6983081-98308143.36943.37
10min11619131-161913171.42872.432.0871.5272.532.08
21646441-164644172.63372.73
31651477-165147772.85572.96
41700443-170044375.01675.13
51631766-163176671.98672.08
61601702-160170270.66070.76
15min11862199-186219982.15182.061.2682.4182.321.26
21824022-182402280.46780.73
31842407-184240781.27881.54
41883708-188370883.10083.38
51883172-188317283.07783.34
61865077-186507782.27882.53
20min11928027-192802785.05585.981.2585.4986.421.26
21956997-195699786.33386.77
31943962-194396285.75886.20
41989273-198927387.75788.22
51954897-195489786.24186.68
61921217-192121784.75585.19
30min11982886-198288687.47688.462.0688.1089.092.06
21977670-197767087.24587.88
32062439-206243990.98591.62
42044408-204440890.19090.85
52007505-200750588.56289.20
61955742-195574286.27886.90
45min12054351-205435190.62890.540.8091.4591.380.80
22048229-204822990.35891.18
32028517-202851789.48990.33
42070644-207064491.34792.21
52069724-206972491.30692.14
62042884-204288490.12290.94
60min12074084-207408491.49991.300.8092.5292.330.81
22056846-205684690.73891.76
32084830-208483091.97393.01
42090629-209062992.22993.29
52062204-206220490.97592.01
62048192-204819290.35791.37
极限12052746-205274690.55790.690.7791.7891.930.77
22043916-204391690.16891.40
32060920-206092090.91892.16
42072434-207243491.42692.69
52071772-207177291.39792.63
62033038-203303889.68890.91
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.181964672196679519661761963250196482719651440.08
210.301997860199640419971320.06
单位质量响应值RSD%判断
193039.69193896.310.32数据可信
加速6月-供试品溶液-2024112421(均一性2)批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1868463-86846340.36048.2710.0440.3648.2710.04
21039756-103975648.32148.32
3977388-97738845.42245.42
41139020-113902052.93452.93
51143122-114312253.12453.12
61064202-106420249.45749.46
10min11562183-156218372.59976.723.6672.6976.833.67
21650164-165016476.68876.80
31607892-160789274.72474.82
41723391-172339180.09180.21
51707642-170764279.35979.48
61654329-165432976.88276.99
15min11862665-186266586.56486.412.3686.8186.692.36
21858966-185896686.39286.67
31787341-178734183.06383.33
41902453-190245388.41388.71
51905623-190562388.56088.85
61839500-183950085.48785.77
20min11907708-190770888.65790.022.3789.1090.492.38
21925081-192508189.46489.93
31881970-188197087.46187.91
41993085-199308592.62593.12
51992677-199267792.60693.10
61921328-192132889.29089.76
30min11999363-199936392.91693.132.2893.5693.802.27
21920622-192062289.25789.93
32006357-200635793.24193.89
42028888-202888894.28994.99
52056266-205626695.56196.26
62012031-201203193.50594.17
45min12041414-204141494.87195.251.5195.7296.121.51
22056281-205628195.56296.43
32017203-201720393.74694.60
42037588-203758894.69395.60
52106987-210698797.91898.83
62037613-203761394.69495.57
60min12044092-204409294.99596.080.8596.0597.160.86
22055370-205537095.51996.60
32062090-206209095.83296.89
42093879-209387997.30998.43
52075342-207534296.44797.57
62073541-207354196.36497.45
极限12087424-208742497.00996.101.0998.2897.401.08
22027887-202788794.24295.53
32071867-207186796.28697.56
42081983-208198396.75698.09
52081501-208150196.73498.07
62056520-205652095.57396.87
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