塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.032956812295732229654302967002296694329627020.18
29.992969543297624029728920.16
单位质量响应值RSD%判断
295384.05297586.790.53数据可信
中间条件24月-供试品溶液-2023011011批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1383326-38332612.87713.065.0612.8813.065.03
2367870-36787012.35812.36
3379451-37945112.74712.75
4388887-38888713.06413.06
5425809-42580914.30514.30
6387505-38750513.01813.02
10min1920788-92078830.93331.833.1230.9531.853.12
2912654-91265430.66030.68
3937359-93735931.49031.51
4962770-96277032.34332.36
5991292-99129233.30133.32
6960636-96063632.27232.29
15min11406358-140635847.24548.061.5147.3148.131.51
21407365-140736547.27947.34
31424329-142432947.84947.92
41438426-143842648.32348.39
51453352-145335248.82448.90
61454354-145435448.85848.93
20min11805495-180549560.65461.401.0360.7961.541.04
21820844-182084461.16961.30
31817155-181715561.04661.18
41825811-182581161.33661.48
51836758-183675861.70461.85
61859762-185976262.47762.62
30min12372222-237222279.69279.940.9979.9280.170.99
22384520-238452080.10680.33
32347104-234710478.84979.08
42376213-237621379.82780.06
52377322-237732279.86480.10
62419248-241924881.27281.51
45min12778008-277800893.32492.911.0793.6793.261.07
22767945-276794592.98693.33
32727670-272767091.63391.98
42765774-276577492.91393.27
52742537-274253792.13392.49
62812911-281291194.49794.85
60min12892159-289215997.15996.560.9897.6597.050.97
22874021-287402196.55097.04
32838887-283888795.37095.86
42873972-287397296.54897.04
52850300-285030095.75396.25
62916113-291611397.96498.46
极限12923402-292340298.20997.530.7798.8498.170.77
22899918-289991897.42098.05
32875472-287547296.59997.23
42907658-290765897.68098.32
52881900-288190096.81597.45
62931353-293135398.47699.12
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.032968557297361629748722969660297307129719550.10
29.993009141300658630078640.07
单位质量响应值RSD%判断
296306.58301087.491.14数据可信
中间条件24月-供试品溶液-2023011011批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1376861-37686112.56713.094.3312.5713.094.35
2383931-38393112.80312.80
3423585-42358514.12514.13
4387243-38724312.91312.91
5399676-39967613.32813.33
6383682-38368212.79512.79
10min1918011-91801130.61331.682.0130.6331.692.01
2948592-94859231.63331.65
3977244-97724432.58832.61
4947007-94700731.58031.60
5955250-95525031.85531.87
6953109-95310931.78331.80
15min11397686-139768646.60947.741.5246.6747.811.52
21432173-143217347.75947.83
31465395-146539548.86648.94
41425692-142569247.54247.61
51435589-143558947.87347.94
61433003-143300347.78647.85
20min11806265-180626560.23360.940.7760.3761.080.77
21823238-182323860.79960.94
31845276-184527661.53461.68
41820316-182031660.70260.84
51831328-183132861.06961.21
61838559-183855961.31061.45
30min12366629-236662978.92079.400.5979.1479.630.59
22371865-237186579.09479.32
32402003-240200380.09980.34
42371069-237106979.06879.30
52392212-239221279.77380.00
62381778-238177879.42579.66
45min12772610-277261092.45892.370.4692.8092.720.46
22750183-275018391.71092.06
32780294-278029492.71493.07
42785170-278517092.87793.22
52768652-276865292.32692.68
62762649-276264992.12692.48
60min12885625-288562596.22795.840.4396.7196.320.43
22856194-285619495.24595.73
32880332-288033296.05096.55
42883958-288395896.17196.66
52862088-286208895.44295.93
62875295-287529595.88296.37
极限12911135-291113597.07896.890.4097.7097.520.40
22893606-289360696.49397.12
32915259-291525997.21597.85
42919736-291973697.36498.00
52894365-289436596.51897.15
62898339-289833996.65197.28
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.032985470297436629757752974449297489229769900.17
29.992991434299287829921560.04
单位质量响应值RSD%判断
296808.57299515.120.65数据可信
中间条件24月-供试品溶液-2023011111批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1392305-39230513.10512.004.6913.1112.004.71
2345514-34551411.54211.54
3352112-35211211.76211.76
4350296-35029611.70211.70
5357838-35783811.95411.95
6358001-35800111.95911.96
10min1981800-98180032.79730.194.4332.8230.204.43
2885298-88529829.57429.59
3900843-90084330.09330.11
4868169-86816929.00229.02
5888430-88843029.67829.70
6897196-89719629.97129.99
15min11492337-149233749.85246.413.8049.9246.483.80
21378356-137835646.04446.11
31388782-138878246.39346.46
41348088-134808845.03345.09
51353804-135380445.22445.29
61374789-137478945.92545.99
20min11867653-186765362.39059.812.5462.5359.942.54
21794387-179438759.94260.07
31804497-180449760.28060.41
41756010-175601058.66058.79
51736240-173624058.00058.13
61784435-178443559.61059.74
30min12404919-240491980.33778.781.8980.5779.001.89
22370703-237070379.19479.41
32395260-239526080.01580.24
42331547-233154777.88678.10
52284754-228475476.32376.54
62363140-236314078.94279.16
45min12792044-279204493.26992.891.6293.6393.231.62
22795194-279519493.37493.71
32836330-283633094.74995.09
42737267-273726791.43991.77
52716769-271676990.75591.09
62806187-280618793.74294.08
60min12888391-288839196.48897.001.5596.9997.481.54
22924337-292433797.68998.17
32963854-296385499.00999.49
42868611-286861195.82796.30
52843488-284348894.98895.46
62933736-293373698.00398.48
极限12932020-293202097.94598.461.4898.5999.091.48
22966913-296691399.11199.74
33008023-3008023100.484101.12
42918651-291865197.49998.11
52886564-288656496.42797.04
62972306-297230699.29199.92
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.032972491297338229701532970151296543929703230.11
29.992994663299570429951840.03
单位质量响应值RSD%判断
296143.87299818.220.88数据可信
中间条件24月-供试品溶液-2023011111批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1373114-37311412.47212.033.0512.4712.033.04
2351167-35116711.73811.74
3356689-35668911.92311.92
4373884-37388412.49812.50
5349310-34931011.67611.68
6354420-35442011.84711.85
10min1927988-92798831.01930.092.4231.0430.102.42
2884548-88454829.56729.58
3899123-89912330.05430.07
4924881-92488130.91530.93
5875508-87550829.26529.28
6888769-88876929.70829.73
15min11423374-142337447.57846.431.8147.6446.501.81
21369991-136999145.79445.86
31369463-136946345.77645.84
41417907-141790747.39547.46
51370035-137003545.79545.86
61383908-138390846.25946.32
20min11818194-181819460.77559.761.3060.9159.891.30
21772253-177225359.24059.37
31765596-176559659.01759.15
41810787-181078760.52860.66
51766172-176617259.03659.17
61794003-179400359.96760.10
30min12389806-238980679.88278.701.0880.1178.921.09
22347682-234768278.47478.69
32322990-232299077.64977.87
42366379-236637979.09979.33
52330577-233057777.90278.12
62369772-236977279.21379.43
45min12779647-277964792.91392.770.6093.2693.110.60
22786043-278604393.12793.46
32763973-276397392.38992.73
42765799-276579992.45092.80
52755713-275571392.11392.45
62800463-280046393.60993.95
60min12913544-291354497.38997.050.8197.8897.530.81
22906565-290656597.15597.63
32895492-289549296.78597.26
42881288-288128896.31196.79
52881091-288109196.30496.78
62942738-294273898.36598.85
极限12947707-294770798.53198.560.9399.1699.190.93
22975137-297513799.448100.07
32952081-295208198.67799.30
42917010-291701097.50598.13
52918281-291828197.54798.17
62981700-298170099.667100.30
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