塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
19.662871170286986928701672868552286853528696590.04
29.602865301285784728615740.19
单位质量响应值RSD%判断
297066.15298080.620.25数据可信
中间条件18月-供试品溶液-2023011011批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1580209-58020919.42021.1911.1319.4221.1911.12
2594912-59491219.91219.91
3762889-76288925.53525.53
4591418-59141819.79519.80
5603340-60334020.19420.19
6665538-66553822.27622.28
10min11205325-120532540.34342.677.2940.3842.727.30
21215629-121562940.68840.73
31434608-143460848.01848.07
41219236-121923640.80940.85
51233075-123307541.27241.31
61341542-134154244.90344.95
15min11719798-171979857.56359.815.1357.6859.935.14
21727845-172784557.83257.95
31933136-193313664.70464.85
41731745-173174557.96358.08
51737238-173723858.14758.27
61870997-187099762.62462.76
20min12124615-212461571.11372.633.5471.3572.883.55
22101725-210172570.34670.58
32302065-230206577.05277.33
42135936-213593671.49271.73
52132633-213263371.38171.62
62222357-222235774.38474.64
30min12663223-266322389.14088.301.5989.5288.691.60
22573715-257371586.14486.52
32683682-268368289.82590.26
42637784-263778488.28988.67
52604469-260446987.17487.56
62665592-266559289.22089.63
45min12881161-288116196.43594.631.7596.9995.201.74
22751371-275137192.09192.64
32818238-281823894.32994.94
42863275-286327595.83696.39
52792782-279278293.47794.03
62857038-285703895.62796.21
60min12894045-289404596.86694.452.1297.6195.212.11
22768531-276853192.66593.40
32836256-283625694.93295.73
42881264-288126496.43897.19
52746257-274625791.92092.66
62805603-280560393.90694.68
极限12892363-289236396.81096.311.0797.7597.261.07
22827971-282797194.65595.57
32890288-289028896.74097.73
42917356-291735697.64698.59
52861364-286136495.77296.70
62874815-287481596.22297.19
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
19.662871120287031228687682868901286992928698060.04
29.602872245287027028712580.05
单位质量响应值RSD%判断
297081.37299089.380.48数据可信
中间条件18月-供试品溶液-2023011011批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1634325-63432521.19520.442.9521.2020.442.96
2602095-60209520.11820.12
3628192-62819220.99020.99
4586091-58609119.58319.58
5603059-60305920.15020.15
6615855-61585520.57820.58
10min11286908-128690843.00041.692.3943.0441.722.38
21229837-122983741.09341.13
31259443-125944342.08342.12
41207549-120754940.34940.39
51231004-123100441.13241.17
61270725-127072542.46042.50
15min11785028-178502859.64458.461.7359.7758.591.73
21728914-172891457.76957.89
31772205-177220559.21659.34
41703615-170361556.92457.04
51744409-174440958.28758.41
61763944-176394458.94059.07
20min12181261-218126172.88471.691.5873.1371.931.58
22123296-212329670.94771.18
32157929-215792972.10472.35
42093393-209339369.94870.18
52139909-213990971.50271.74
62177667-217766772.76473.01
30min12693354-269335489.99588.191.5390.3988.581.54
22599795-259979586.86987.25
32633961-263396188.01088.40
42591580-259158086.59486.97
52641818-264181888.27388.65
62676105-267610589.41889.81
45min12872248-287224895.97295.221.2196.5595.781.21
22797238-279723893.46694.02
32851651-285165195.28495.85
42858960-285896095.52896.08
52824223-282422394.36894.93
62893232-289323296.67397.24
60min12891451-289145196.61495.621.1997.3896.371.19
22813597-281359794.01294.75
32874803-287480396.05896.81
42855585-285558595.41596.15
52833844-283384494.68995.44
62901576-290157696.95297.71
极限12899770-289977096.89297.270.8997.8598.220.88
22874732-287473296.05596.98
32930106-293010697.90598.85
42916067-291606797.43698.37
52899193-289919396.87397.81
62947263-294726398.47999.43
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
19.662869744286458928646982864038286258128651300.10
29.602862419286332928628740.03
单位质量响应值RSD%判断
296597.31298216.040.39数据可信
中间条件18月-供试品溶液-2023011111批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1783232-78323226.23021.3911.1826.2321.3911.18
2601504-60150420.14420.14
3619833-61983320.75820.76
4596597-59659719.98019.98
5614095-61409520.56620.57
6617216-61721620.67020.67
10min11405787-140578747.07942.535.4047.1342.585.41
21247203-124720341.76941.81
31235384-123538441.37341.41
41215328-121532840.70140.74
51252823-125282341.95742.00
61263635-126363542.31942.36
15min11908192-190819263.90559.663.7964.0559.783.80
21746522-174652258.49158.61
31748328-174832858.55158.68
41716506-171650657.48557.61
51776259-177625959.48659.61
61792032-179203260.01560.14
20min12333183-233318378.13873.183.7078.4173.433.70
22139257-213925771.64371.88
32134568-213456871.48671.73
42113204-211320470.77171.01
52178828-217882872.96873.21
62212037-221203774.08174.33
30min12807647-280764794.02789.343.0194.4689.733.02
22649493-264949388.73189.11
32606727-260672787.29987.68
42600355-260035587.08587.46
52626278-262627887.95388.34
62715380-271538090.93791.33
45min13019538-3019538101.12498.152.77101.7498.722.77
22991073-2991073100.170100.73
32843341-284334195.22395.78
42834356-283435694.92295.47
52904749-290474997.27997.85
62990916-2990916100.165100.74
60min13040195-3040195101.81599.132.63102.6499.902.63
23020043-3020043101.140101.90
32983348-298334899.912100.66
42846477-284647795.32896.07
52882904-288290496.54897.31
62986471-2986471100.016100.79
极限13053485-3053485102.260100.391.84103.29101.361.85
23060116-3060116102.483103.45
32991733-2991733100.192101.14
42921287-292128797.83398.77
52950653-295065398.81799.77
63008337-3008337100.748101.72
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
19.662861587286444128605602863948286040428621880.07
29.602879012287512528770680.10
单位质量响应值RSD%判断
296292.75299694.580.81数据可信
中间条件18月-供试品溶液-2023011111批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1595264-59526419.89619.461.7119.9019.461.71
2585679-58567919.57619.58
3590497-59049719.73719.74
4572489-57248919.13519.14
5578915-57891519.35019.35
6570412-57041219.06619.07
10min11292765-129276543.21042.441.7943.2542.481.79
21288231-128823143.05943.10
31287368-128736843.03043.07
41246276-124627641.65641.69
51261224-126122442.15642.19
61242247-124224741.52241.56
15min11854176-185417661.97560.541.5462.1060.661.54
21825371-182537161.01261.14
31818438-181843860.78160.91
41787985-178798559.76359.88
51805295-180529560.34160.46
61776456-177645659.37759.50
20min12283347-228334776.32074.461.5476.5774.701.54
22236311-223631174.74875.00
32231301-223130174.58074.83
42194006-219400673.33473.57
52232166-223216674.60974.85
62188720-218872073.15773.40
30min12770941-277094192.61891.330.8593.0291.720.85
22706707-270670790.47190.87
32740929-274092991.61592.01
42711959-271195990.64691.03
52736715-273671591.47491.87
62727505-272750591.16691.55
45min12953790-295379098.72998.260.8799.3298.840.87
22901014-290101496.96597.54
32932572-293257298.02098.60
42936467-293646798.15098.72
52978384-297838499.551100.13
62936118-293611898.13998.71
60min12958533-295853398.88898.470.9999.6799.240.98
22904439-290443997.08097.85
32934989-293498998.10198.88
42945972-294597298.46899.23
52992425-2992425100.021100.80
62939566-293956698.25499.02
极限12954020-295402098.73798.450.9199.7299.420.90
22904650-290465097.08798.05
32942167-294216798.34199.31
42944034-294403498.40399.37
52987499-298749999.856100.83
62940443-294044398.28399.24
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