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%
19.961527981152851215260931527041152573315270720.08
29.921526444152770815270760.06
单位质量响应值RSD%判断
153320.48153939.110.29数据可信
中间条件24月-供试品溶液-2023010511批-pH4.5(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%
5min1138259-1382598.9649.558.668.969.558.67
2158353-15835310.26610.27
3160184-16018410.38510.38
4129236-1292368.3798.38
5156369-15636910.13810.14
6141359-1413599.1659.16
10min1368737-36873723.90623.525.8623.9223.545.86
2373559-37355924.21824.23
3384305-38430524.91524.93
4338794-33879421.96521.98
5377721-37772124.48824.50
6333738-33373821.63721.65
15min1600294-60029438.91837.375.2238.9737.425.23
2597448-59744838.73338.79
3589652-58965238.22838.28
4547196-54719635.47635.52
5593907-59390738.50438.56
6529773-52977334.34634.39
20min1809323-80932352.47050.014.2252.5850.114.22
2786376-78637650.98251.09
3767499-76749949.75849.87
4752228-75222848.76848.87
5793604-79360451.45051.56
6718988-71898846.61346.71
30min11133999-113399973.51970.413.6173.7170.583.61
21119481-111948172.57872.76
31060380-106038068.74668.93
41071127-107112769.44369.61
51100959-110095971.37771.56
61029931-102993166.77266.94
45min11385709-138570989.83888.291.5190.1388.571.51
21382890-138289089.65589.95
31331592-133159286.32986.62
41357416-135741688.00388.28
51363529-136352988.40088.69
61349597-134959787.49687.76
60min11436056-143605693.10293.401.0993.5393.821.08
21457944-145794494.52194.95
31431068-143106892.77893.20
41437094-143709493.16993.58
51420969-142096992.12392.55
61460941-146094194.71595.11
极限11472069-147206995.43695.951.2496.0196.511.23
21504858-150485897.56298.13
31479968-147996895.94896.51
41479020-147902095.88796.43
51451288-145128894.08994.65
61492912-149291296.78897.33
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%
19.961521709153058215287281528298152599515270620.23
29.921519364151854415189540.04
单位质量响应值RSD%判断
153319.48153120.360.10数据可信
中间条件24月-供试品溶液-2023010511批-pH4.5(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%
5min1148190-1481909.6339.712.409.639.702.38
2154506-15450610.04410.04
3148371-1483719.6459.64
4151959-1519599.8789.88
5148804-1488049.6739.67
6144070-1440709.3659.37
10min1368889-36888923.97923.653.0023.9923.662.99
2361940-36194023.52823.54
3362427-36242723.55923.57
4351080-35108022.82222.84
5355991-35599123.14123.16
6382268-38226824.84924.86
15min1590820-59082038.40637.162.2438.4637.212.24
2567160-56716036.86836.92
3564644-56464436.70436.75
4568001-56800136.92336.97
5556464-55646436.17336.22
6583218-58321837.91237.96
20min1789973-78997351.35249.522.1151.4649.622.11
2751954-75195448.88048.99
3746670-74667048.53748.64
4754775-75477549.06449.17
5756253-75625349.16049.26
6771081-77108150.12450.23
30min11107771-110777172.01070.281.8272.2070.461.82
21090244-109024470.87171.05
31052514-105251468.41868.60
41089711-108971170.83671.01
51081103-108110370.27770.45
61065737-106573769.27869.46
45min11386777-138677790.14787.591.6490.4487.881.64
21328230-132823086.34186.63
31336987-133698786.91087.19
41351630-135163087.86288.15
51352772-135277287.93688.22
61328383-132838386.35186.64
60min11429734-142973492.93992.570.6193.3792.990.61
21416717-141671792.09392.51
31426435-142643592.72593.14
41430594-143059492.99593.41
51430790-143079093.00893.42
61410049-141004991.66092.08
极限11468839-146883995.48194.950.6996.0595.510.69
21460823-146082394.96095.51
31452897-145289794.44594.99
41462268-146226895.05495.61
51473316-147331695.77296.33
61446305-144630594.01794.57
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%
19.961513728151319815125851514535151367315135440.05
29.921510435150879715096160.08
单位质量响应值RSD%判断
151962.25152179.030.11数据可信
中间条件24月-供试品溶液-2023010611批-pH4.5(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%
5min1134703-1347038.8228.495.358.828.495.36
2129190-1291908.4618.46
3120224-1202247.8747.87
4124389-1243898.1478.15
5129405-1294058.4758.48
6139500-1395009.1379.14
10min1328966-32896621.54621.804.7721.5621.824.77
2337973-33797322.13622.15
3333453-33345321.84021.85
4313291-31329120.51920.53
5323437-32343721.18421.20
6360137-36013723.58823.60
15min1526521-52652134.48535.313.9434.5335.353.94
2544503-54450335.66335.71
3548405-54840535.91835.96
4511940-51194033.53033.57
5530048-53004834.71634.76
6573089-57308937.53537.58
20min1718150-71815047.03648.083.5147.1348.183.51
2744645-74464548.77148.87
3750937-75093749.18349.28
4705244-70524446.19146.28
5713635-71363546.74046.84
6771764-77176450.54750.65
30min11045599-104559968.48269.182.1868.6569.352.19
21066558-106655869.85570.03
31066490-106649069.85170.02
41028323-102832367.35167.51
51039227-103922768.06568.23
61091644-109164471.49871.68
45min11377423-137742390.21689.251.2190.4989.531.21
21352863-135286388.60788.88
31371670-137167089.83990.12
41356523-135652388.84789.11
51337853-133785387.62487.89
61380014-138001490.38590.67
60min11470003-147000396.27995.121.2796.6995.531.26
21419207-141920792.95293.36
31462236-146223695.77096.18
41462629-146262995.79696.19
51454731-145473195.27995.68
61444871-144487194.63395.06
极限11496593-149659398.02196.831.3498.5797.381.33
21442669-144266994.48995.04
31494433-149443397.87998.43
41486029-148602997.32997.87
51477388-147738896.76397.31
61473104-147310496.48297.05
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%
19.961511539151241515109051511318151293915118230.06
29.921515214151502815151210.01
单位质量响应值RSD%判断
151789.46152733.970.44数据可信
中间条件24月-供试品溶液-2023010611批-pH4.5(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%
5min1132681-1326818.6798.858.708.688.858.71
2121398-1213987.9417.94
3146695-1466959.5969.60
4152402-1524029.9699.97
5129331-1293318.4608.46
6129485-1294858.4708.47
10min1328870-32887021.51321.642.5421.5321.662.53
2324302-32430221.21421.23
3339735-33973522.22422.24
4321769-32176921.04821.06
5327959-32795921.45321.47
6342452-34245222.40122.41
15min1528574-52857434.57635.082.6434.6235.132.65
2529970-52997034.66834.71
3547883-54788335.83935.89
4523008-52300834.21234.26
5529103-52910334.61134.66
6559493-55949336.59936.65
20min1723695-72369547.34047.822.1547.4447.922.15
2731196-73119647.83147.93
3734606-73460648.05448.16
4710862-71086246.50146.60
5727091-72709147.56247.66
6758324-75832449.60549.71
30min11046629-104662968.46568.981.1268.6369.151.12
21051746-105174668.79968.97
31063980-106398069.60069.77
41042128-104212868.17068.34
51049348-104934868.64268.81
61073268-107326870.20770.38
45min11346326-134632688.06988.640.8588.3488.910.85
21363185-136318589.17289.44
31346747-134674788.09788.37
41355465-135546588.66788.94
51344797-134479787.96988.24
61373583-137358389.85290.13
60min11450991-145099194.91694.860.6795.3295.270.66
21453401-145340195.07395.48
31445702-144570294.57094.98
41465744-146574495.88196.28
51436458-143645893.96594.37
61448951-144895194.78295.20
极限11449329-144932994.80795.970.9395.3596.520.92
21477998-147799896.68297.23
31471267-147126796.24296.79
41483877-148387797.06797.61
51453777-145377795.09895.64
61466499-146649995.93096.49
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%
19.961520251151898515194681519095152005615195710.04
29.921527191152332615252580.18
单位质量响应值RSD%判断
152567.37153755.850.55数据可信
中间条件24月-供试品溶液-2023010711批-pH4.5(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%
5min1160230-16023010.42013.5013.1210.4213.5013.12
2236565-23656515.38415.38
3211332-21133213.74313.74
4224051-22405114.57014.57
5219860-21986014.29814.30
6193735-19373512.59912.60
10min1401990-40199026.14232.3811.3826.1632.4011.38
2560829-56082936.47136.49
3514818-51481833.47933.50
4532228-53222834.61134.63
5514170-51417033.43733.46
6463782-46378230.16030.18
15min1638824-63882441.54349.7710.3541.6049.8410.35
2851922-85192255.40155.48
3795061-79506151.70351.77
4825556-82555653.68653.76
5772173-77217350.21550.29
6708060-70806046.04546.11
20min1838275-83827554.51364.9110.3654.6365.0610.36
21111741-111174172.29772.46
31044874-104487467.94968.10
41080949-108094970.29470.45
5991803-99180364.49764.64
6921387-92138759.91860.05
30min11158053-115805375.30984.366.3775.5184.606.38
21370153-137015389.10289.37
31349945-134994587.78788.04
41358539-135853988.34688.61
51302621-130262184.71084.95
61244303-124430380.91781.14
45min11424840-142484092.65894.471.1692.9794.831.19
21459660-145966094.92295.33
31453024-145302494.49194.87
41459390-145939094.90595.30
51474532-147453295.88996.26
61444339-144433993.92694.27
60min11470207-147020795.60895.980.6396.0696.490.63
21471699-147169995.70596.25
31472649-147264995.76796.29
41476984-147698496.04996.58
51493896-149389697.14997.66
61470092-147009295.60196.09
极限11489762-148976296.88097.140.5697.4797.800.55
21488118-148811896.77397.46
31491824-149182497.01497.68
41488495-148849596.79797.48
51509884-150988498.18898.85
61494850-149485097.21197.84
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%
19.961515196151504715167751517479151849415165980.10
29.921505194150567515054340.03
单位质量响应值RSD%判断
152268.88151757.460.24数据可信
中间条件24月-供试品溶液-2023010711批-pH4.5(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%
5min1199204-19920413.05213.576.3313.0513.576.35
2216068-21606814.15714.16
3207390-20739013.58813.59
4189907-18990712.44312.44
5227199-22719914.88614.89
6203080-20308013.30613.31
10min1477004-47700431.25432.495.1231.2732.515.13
2521288-52128834.15534.18
3487769-48776931.95931.98
4468360-46836030.68730.71
5532393-53239334.88334.91
6488202-48820231.98732.01
15min1737890-73789048.34750.214.9248.4150.284.93
2807503-80750352.90852.98
3747343-74734348.96749.03
4731844-73184447.95148.02
5820066-82006653.73153.81
6753458-75345849.36749.44
20min1969121-96912163.49865.164.6563.6465.304.65
21057885-105788569.31369.47
3950785-95078562.29662.44
4955641-95564162.61462.75
51045099-104509968.47668.63
6988413-98841364.76264.90
30min11250048-125004881.90484.713.1282.1484.953.13
21346940-134694088.25388.51
31269953-126995383.20883.44
41260328-126032882.57882.81
51334981-133498187.46987.73
61294789-129478984.83685.07
45min11447499-144749994.84195.120.6295.2095.480.62
21452974-145297495.20095.59
31457765-145776595.51495.87
41438821-143882194.27394.63
51464483-146448395.95496.34
61448521-144852194.90895.27
60min11463000-146300095.85796.450.4396.3696.960.43
21468837-146883796.23996.77
31478624-147862496.88197.38
41468592-146859296.22396.72
51477665-147766596.81897.35
61475541-147554196.67997.19
极限11488000-148800097.49597.470.4298.1498.130.42
21484330-148433097.25597.93
31495534-149553497.98998.64
41486387-148638797.38998.03
51493237-149323797.83898.52
61478327-147832796.86197.51
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