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%
19.712925625292449829202942929401292214829243930.12
29.772930094293140529307500.04
单位质量响应值RSD%判断
301173.33299974.410.29数据可信
供试品溶液-2023011011批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1336184-33618411.14011.2510.2611.1411.2510.26
2400674-40067413.27713.28
3349400-34940011.57811.58
4300877-3008779.9709.97
5335934-33593411.13211.13
6313125-31312510.37610.38
10min1819372-81937227.15127.176.5027.1727.196.51
2903729-90372929.94729.97
3836591-83659127.72227.74
4738901-73890124.48524.50
5819946-81994627.17027.19
6801549-80154926.56126.58
15min11273008-127300842.18342.054.9742.2442.104.98
21358456-135845645.01545.08
31290971-129097142.77942.84
41162849-116284938.53338.58
51264977-126497741.91741.97
61262919-126291941.84941.90
20min11653060-165306054.77754.904.2154.9055.024.21
21744561-174456157.80957.94
31685284-168528455.84555.97
41531933-153193350.76350.87
51656325-165632554.88555.01
61668599-166859955.29255.41
30min12190057-219005772.57173.202.9472.7773.402.94
22283397-228339775.66475.88
32234521-223452174.04574.25
42092382-209238269.33569.52
52218058-221805873.49973.70
62236579-223657974.11374.31
45min12653339-265333987.92387.991.8088.2388.311.81
22702218-270221889.54389.88
32679126-267912688.77889.10
42564046-256404684.96485.25
52669426-266942688.45688.77
62664850-266485088.30488.62
60min12814065-281406593.24993.510.9493.6993.960.95
22845356-284535694.28694.75
32841489-284148994.15894.61
42773145-277314591.89392.31
52830209-283020993.78494.23
62827594-282759493.69794.14
极限12886947-288694795.66495.600.9596.2596.180.96
22909506-290950696.41297.02
32900172-290017296.10296.69
42832140-283214093.84894.40
52888978-288897895.73196.32
62892240-289224095.83996.42
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%
19.712933281293308229334852933189293204529330160.02
29.772934311293302729336690.04
单位质量响应值RSD%判断
302061.38300273.180.42数据可信
供试品溶液-第1批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1347423-34742311.49010.7713.5811.4910.7713.59
2297734-2977349.8479.85
3325136-32513610.75310.75
4299108-2991089.8929.89
5402377-40237713.30713.31
6281716-2817169.3179.32
10min1847627-84762728.03227.0611.0728.0527.0811.07
2760769-76076925.16025.17
3837764-83776427.70627.72
4749988-74998824.80324.82
5976619-97661932.29832.32
6736444-73644424.35524.37
15min11310043-131004343.32542.378.7343.3842.428.73
21203036-120303639.78639.84
31316137-131613743.52743.58
41193167-119316739.46039.51
51475961-147596148.81248.88
61188167-118816739.29539.35
20min11702736-170273656.31255.546.1956.4455.666.19
21630574-163057453.92654.04
31724999-172499957.04857.17
41576882-157688252.15052.26
51852735-185273561.27361.41
61588048-158804852.51952.63
30min12234374-223437473.89473.494.0374.1073.694.04
22149493-214949371.08771.28
32262806-226280674.83575.04
42142029-214202970.84071.03
52375739-237573978.57078.80
62168299-216829971.70971.90
45min12655079-265507987.80887.891.5188.1388.201.53
22638790-263879087.26987.57
32658664-265866487.92688.25
42621652-262165286.70287.00
52734490-273449090.43490.79
62636028-263602887.17887.47
60min12808665-280866592.88793.220.7093.3493.660.71
22812423-281242393.01193.44
32803116-280311692.70493.16
42809283-280928392.90893.33
52856758-285675894.47894.96
62821842-282184293.32393.75
极限12869894-286989494.91295.350.5095.5095.930.50
22878844-287884495.20895.78
32864226-286422694.72595.32
42894595-289459595.72996.29
52899175-289917595.88096.51
62891350-289135095.62296.19
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%
19.712914833291732029199792919828291118229166280.13
29.772922591292752829250600.12
单位质量响应值RSD%判断
300373.64299392.020.24数据可信
供试品溶液-2023011011批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1331347-33134711.00510.397.6211.0110.407.63
2306567-30656710.18210.18
3319143-31914310.60010.60
4338928-33892811.25711.26
5310580-31058010.31510.32
6271202-2712029.0079.01
10min1824352-82435227.37925.126.4627.4025.146.46
2724558-72455824.06524.08
3768602-76860225.52825.54
4771643-77164325.62925.65
5769028-76902825.54225.56
6680616-68061622.60522.62
15min11263561-126356141.96738.595.6342.0238.645.63
21108104-110810436.80436.85
31193099-119309939.62639.68
41180292-118029239.20139.26
51144741-114474138.02038.07
61081266-108126635.91235.96
20min11587694-158769452.73250.283.6452.8550.393.65
21468552-146855248.77548.88
31547127-154712751.38551.50
41539495-153949551.13151.25
51501590-150159049.87249.98
61438277-143827747.77047.87
30min12076001-207600168.95067.761.9169.1567.951.92
22007685-200768566.68166.86
32070727-207072768.77568.97
42065023-206502368.58668.78
52041931-204193167.81968.00
61979869-197986965.75865.93
45min12538036-253803684.29683.802.0784.6084.092.07
22469686-246968682.02682.31
32510772-251077283.39083.68
42531808-253180884.08984.38
52612749-261274986.77787.06
62475880-247588082.23282.50
60min12714261-271426190.14990.331.6490.5890.741.63
22668669-266866988.63589.04
32703122-270312289.77990.20
42714359-271435990.15290.57
52714571-271457190.15990.58
62803020-280302093.09793.49
极限12792339-279233992.74292.420.4993.3192.970.49
22757588-275758891.58892.12
32792553-279255392.74993.30
42791150-279115092.70393.26
52780157-278015792.33892.89
62782893-278289392.42892.96
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%
19.712919052292338129202972918750291748629197930.08
29.772929848293480629323270.12
单位质量响应值RSD%判断
300699.59300135.820.14数据可信
供试品溶液-第1批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1339057-33905711.24110.6911.0411.2410.6911.06
2324491-32449110.75810.76
3272135-2721359.0229.02
4335393-33539311.12011.12
5371476-37147612.31612.32
6291737-2917379.6729.67
10min1788242-78824226.13325.206.8226.1525.216.83
2786485-78648526.07526.09
3696429-69642923.08923.10
4760912-76091225.22725.24
5826732-82673227.40927.43
6701533-70153323.25923.27
15min11205164-120516439.95638.775.5940.0138.825.60
21214720-121472040.27340.33
31096450-109645036.35236.40
41128819-112881937.42537.48
51257978-125797841.70741.77
61112718-111271836.89136.94
20min11575902-157590252.24751.026.0852.3651.136.07
21594028-159402852.84852.96
31456019-145601948.27348.38
41447177-144717747.98048.09
51681297-168129755.74155.86
61478079-147807949.00449.11
30min12108595-210859569.90868.762.7370.1068.952.74
22135861-213586170.81271.01
32007129-200712966.54466.72
42046126-204612667.83768.02
52126225-212622570.49370.70
62019317-201931766.94867.13
45min12560799-256079984.90083.891.8085.2084.181.81
22576005-257600585.40585.71
32490473-249047382.56982.84
42476516-247651682.10682.39
52575537-257553785.38985.70
62502625-250262582.97283.25
60min12736335-273633590.72090.120.8991.1590.530.90
22744175-274417590.98091.41
32685491-268549189.03489.43
42704062-270406289.65090.06
52736776-273677690.73591.17
62701899-270189989.57889.98
极限12804972-280497292.99693.811.9793.5694.371.96
22808031-280803193.09793.66
32778382-277838292.11492.65
42799962-279996292.83093.37
52930195-293019597.14797.72
62856328-285632894.69895.24
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