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%
19.662875785287702328761152872618286841928739920.13
29.602867648286331628654820.11
单位质量响应值RSD%判断
297514.70298487.710.24数据可信
长期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%
5min1602573-60257320.14021.194.5420.1421.204.54
2639843-63984321.38521.39
3619788-61978820.71520.72
4614799-61479920.54820.55
5683398-68339822.84122.84
6644154-64415421.52921.53
10min11284671-128467142.93744.523.8642.9844.563.86
21341885-134188544.85044.89
31304782-130478243.60943.65
41289740-128974043.10743.15
51421471-142147147.51047.56
61349950-134995045.11945.16
15min11809258-180925860.47062.993.2260.6063.123.22
21904149-190414963.64263.77
31862894-186289462.26362.39
41843356-184335661.61061.74
51983109-198310966.28166.42
61905657-190565763.69263.83
20min12223712-222371274.32377.182.4774.5777.442.48
22328781-232878177.83478.09
32284202-228420276.34476.60
42291192-229119276.57876.83
52392143-239214379.95280.23
62336039-233603978.07778.34
30min12731567-273156791.29793.351.6391.6993.761.64
22825788-282578894.44694.86
32770356-277035692.59393.00
42766258-276625892.45692.86
52856437-285643795.47095.90
62807355-280735593.83094.25
45min12937818-293781898.19098.440.4198.7799.040.43
22949316-294931698.57499.18
32935436-293543698.11098.70
42937515-293751598.18098.77
52967499-296749999.18299.81
62943366-294336698.37598.98
60min12946881-294688198.49398.500.3599.2799.290.36
22950998-295099898.63199.43
32939442-293944298.24499.03
42935906-293590698.12698.91
52964680-296468099.08899.91
62944054-294405498.39899.20
极限12941600-294160098.31698.440.3699.2999.430.37
22951996-295199698.66499.66
32941933-294193398.32899.31
42935543-293554398.11499.10
52963383-296338399.044100.07
62937419-293741998.17799.17
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%
19.662868795287046428681142870183287155028698210.05
29.602870514287520828728610.12
单位质量响应值RSD%判断
297082.92299256.350.52数据可信
长期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%
5min1601027-60102720.07720.293.0120.0820.293.01
2630145-63014521.05021.05
3580130-58013019.37919.38
4625425-62542520.89220.89
5600820-60082020.07020.07
6606858-60685820.27220.27
10min11292237-129223743.16643.241.5643.2143.281.55
21317496-131749644.01044.05
31275581-127558142.61042.65
41320562-132056244.11244.15
51275717-127571742.61442.65
61285034-128503442.92642.97
15min11816169-181616960.66861.091.2360.7961.221.23
21848679-184867961.75461.88
31801963-180196360.19360.32
41862421-186242162.21362.34
51824064-182406460.93161.06
61820000-182000060.79660.92
20min12217885-221788574.08774.660.8574.3374.910.86
22235414-223541474.67274.93
32218477-221847774.10774.35
42268648-226864875.78276.04
52227922-222792274.42274.67
62242430-224243074.90775.15
30min12722127-272212790.93191.560.6591.3391.960.65
22734311-273431191.33891.74
32727689-272768991.11691.51
42771465-277146592.57992.98
52741436-274143691.57691.97
62749112-274911291.83292.23
45min12916587-291658797.42698.280.8598.0098.860.85
22912644-291264497.29597.88
32938479-293847998.15898.73
42963098-296309898.98099.57
52945976-294597698.40898.99
62975443-297544399.39299.97
60min12923246-292324697.64998.500.9498.4299.280.93
22912308-291230897.28398.06
32949448-294944898.52499.30
42962670-296267098.96699.75
52957535-295753598.79499.57
62987727-298772799.803100.58
极限12925204-292520497.71498.310.8998.6899.290.88
22906269-290626997.08298.06
32942175-294217598.28199.25
42961384-296138498.92399.91
52943648-294364898.33099.30
62980288-298028899.554100.53
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%
19.662872847287419528751972870403287624328737770.08
29.602872348287566828740080.09
单位质量响应值RSD%判断
297492.44299375.830.45数据可信
长期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%
5min1590790-59079019.71719.411.8519.7219.411.83
2582570-58257019.44319.44
3580787-58078719.38319.38
4595492-59549219.87419.87
5571554-57155419.07519.08
6567694-56769418.94718.95
10min11272968-127296842.48542.061.2042.5242.101.20
21258485-125848542.00142.04
31260686-126068642.07542.11
41278461-127846142.66842.71
51235370-123537041.23041.27
61256312-125631241.92941.97
15min11817307-181730760.65260.140.7460.7860.270.75
21797356-179735659.98660.11
31806967-180696760.30760.43
41809540-180954060.39360.52
51778677-177867759.36359.48
61802397-180239760.15460.28
20min12243902-224390274.88974.260.8475.1374.500.84
22228227-222822774.36674.61
32220508-222050874.10874.35
42235556-223555674.61174.86
52190468-219046873.10673.35
62231344-223134474.47074.71
30min12756176-275617691.98691.120.9692.3891.510.95
22750135-275013591.78492.18
32744070-274407091.58291.97
42725398-272539890.95991.35
52685917-268591789.64190.03
62718928-271892890.74391.13
45min12973647-297364799.24498.221.1599.8298.791.15
22946075-294607598.32498.90
32982390-298239099.536100.11
42947934-294793498.38698.96
52908779-290877997.07997.64
62898188-289818896.72697.30
60min12977637-297763799.37798.611.18100.1699.381.18
22958005-295800598.72299.49
32996446-2996446100.005100.78
42967001-296700199.02299.80
52928425-292842597.73598.49
62900764-290076496.81297.58
极限12972112-297211299.19398.571.07100.1799.541.07
22957071-295707198.69199.66
32990633-299063399.811100.78
42966028-296602898.99099.96
52932379-293237997.86798.82
62902642-290264296.87497.83
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%
19.662875919287065328751032870431287393728732090.09
29.602868542286695128677460.04
单位质量响应值RSD%判断
297433.64298723.540.31数据可信
长期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%
5min1572414-57241419.12720.184.3819.1320.184.38
2579567-57956719.36619.37
3593617-59361719.83519.84
4636120-63612021.25521.26
5611569-61156920.43520.44
6630445-63044521.06621.07
10min11238798-123879841.39342.983.8141.4343.023.81
21252138-125213841.83941.88
31250758-125075841.79341.83
41362509-136250945.52745.57
51288368-128836843.05043.09
61324356-132435644.25244.29
15min11752318-175231858.55260.613.3258.6760.743.32
21773912-177391259.27459.40
31775570-177557059.32959.45
41911096-191109663.85863.99
51814646-181464660.63560.76
61856203-185620362.02362.15
20min12163646-216364672.29673.981.9472.5374.231.94
22182318-218231872.92073.16
32187064-218706473.07973.32
42273639-227363975.97276.23
52232080-223208074.58374.83
62246059-224605975.05075.30
30min12634073-263407388.01590.081.3888.4090.481.38
22697022-269702290.11990.51
32673764-267376489.34289.73
42723030-272303090.98891.40
52735623-273562391.40991.81
62711640-271164090.60791.01
45min12868922-286892295.86397.241.3396.4297.821.33
22966402-296640299.12099.69
32881631-288163196.28796.85
42892273-289227396.64397.24
52947698-294769898.49599.08
62903623-290362397.02297.61
60min12879004-287900496.20097.481.3696.9598.251.36
22982934-298293499.672100.44
32894626-289462696.72297.48
42889498-288949896.55097.34
52945301-294530198.41599.19
62913231-291323197.34398.12
极限12896919-289691996.79897.611.4097.7498.581.39
22991532-299153299.960100.92
32889047-288904796.53597.49
42895245-289524596.74297.72
52949833-294983398.56699.54
62905266-290526697.07798.05
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