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%
110.173028976303003230317583024820302518930281550.11
210.113029557302533030274440.10
单位质量响应值RSD%判断
297753.69299450.450.41数据可信
供试品溶液-2023011111批-pH12.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1730878-73087824.37924.549.7224.3824.549.73
2628209-62820920.95420.95
3737321-73732124.59424.59
4747933-74793324.94824.95
5852063-85206328.42128.42
6718656-71865623.97123.97
10min11362681-136268145.45349.117.4745.4949.157.47
21356699-135669945.25445.29
31589628-158962853.02353.06
41490536-149053649.71849.76
51609197-160919753.67653.72
61425522-142552247.54947.59
15min11917076-191707663.94568.236.9164.0568.346.91
21868603-186860362.32962.43
32183102-218310272.81972.94
42133621-213362171.16871.28
52190305-219030573.05973.18
61980444-198044466.05966.17
20min12360658-236065878.74181.924.6078.9482.144.61
22301589-230158976.77176.96
32523585-252358584.17684.40
42554775-255477585.21685.44
52578551-257855186.00986.24
62417262-241726280.62980.84
30min12827460-282746094.31295.632.3094.6395.962.31
22760033-276003392.06392.37
32877820-287782095.99296.34
42952988-295298898.49998.85
52893831-289383196.52696.89
62889084-288908496.36796.69
45min12953704-295370498.52399.251.5798.9899.731.58
22898975-289897596.69797.14
32960903-296090398.76399.26
43015002-3015002100.567101.06
53015089-3015089100.570101.08
63009492-3009492100.384100.86
60min12947252-294725298.30899.311.2198.9299.931.21
22942630-294263098.15398.74
32968853-296885399.02899.67
43034464-3034464101.217101.86
52964462-296446298.88299.54
63005362-3005362100.246100.87
极限12946844-294684498.29499.020.7899.0599.800.79
22942813-294281398.16098.90
32964869-296486998.89599.69
42995237-299523799.908100.71
52965501-296550198.91699.72
62996727-299672799.958100.73
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%
110.173031615303213630293243028790302817930300090.06
210.113025676302423730249560.04
单位质量响应值RSD%判断
297935.99299204.350.31数据可信
供试品溶液-2批-pH12.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1607159-60715920.25420.654.2720.2520.654.28
2624712-62471220.84020.84
3633361-63336121.12821.13
4661792-66179222.07722.08
5594824-59482419.84319.84
6592677-59267719.77119.77
10min11333196-133319644.47445.222.6044.5045.242.60
21364635-136463545.52345.55
31385090-138509046.20546.24
41405325-140532546.88046.91
51320990-132099044.06744.10
61323246-132324644.14244.17
15min11936788-193678864.61065.293.2364.7165.393.23
21962831-196283165.47865.58
31966605-196660565.60465.71
42065007-206500768.88768.99
51941513-194151364.76764.86
61870793-187079362.40862.50
20min12412951-241295180.49480.112.4280.6980.312.42
22383781-238378179.52179.72
32413921-241392180.52680.73
42493461-249346183.18083.39
52390027-239002779.72979.92
62314333-231433377.20477.39
30min12927779-292777997.66897.871.7197.9898.191.70
22908595-290859597.02897.35
32915161-291516197.24797.57
42958453-295845398.69199.02
53019276-3019276100.720101.03
62874446-287444695.88996.19
45min13053818-3053818101.873101.250.71102.33101.710.70
23038262-3038262101.354101.82
33049338-3049338101.723102.19
43011911-3011911100.475100.95
53051995-3051995101.812102.28
63005486-3005486100.260100.71
60min13064673-3064673102.235101.360.89102.85101.980.89
23046721-3046721101.636102.25
33060294-3060294102.089102.71
43015216-3015216100.585101.22
53047650-3047650101.667102.28
62996449-299644999.959100.56
极限13068238-3068238102.354101.600.65103.12102.370.64
23049607-3049607101.732102.50
33050815-3050815101.773102.54
43008682-3008682100.367101.15
53046085-3046085101.615102.38
63050786-3050786101.772102.52
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%
110.173022692302335630200883022731301917730216090.07
210.113024552302109730228240.09
单位质量响应值RSD%判断
297110.03298993.470.45数据可信
供试品溶液-25010702批-pH12.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1591215-59121519.75720.092.2119.7620.092.20
2585824-58582419.57719.58
3599246-59924620.02520.03
4598220-59822019.99119.99
5610060-61006020.38720.39
6622477-62247720.80220.80
10min11308519-130851943.72744.482.5743.7644.512.57
21309801-130980143.77043.80
31288083-128808343.04443.07
41366135-136613545.65345.68
51342262-134226244.85544.89
61371976-137197645.84845.88
15min11823484-182348460.93663.173.5961.0363.273.59
21865034-186503462.32462.42
31813322-181332260.59660.69
41980280-198028066.17666.27
51911727-191172763.88563.98
61948393-194839365.11065.21
20min12228810-222881074.48177.813.9974.6778.003.98
22317363-231736377.44077.63
32214418-221441874.00074.19
42443882-244388281.66881.87
52364243-236424379.00779.20
62401592-240159280.25580.45
30min12751345-275134591.94393.762.1092.2494.072.10
22827616-282761694.49194.80
32719814-271981490.88991.19
42876172-287617296.11496.43
52816610-281661094.12494.44
62842594-284259494.99295.31
45min12949840-294984098.57699.060.8699.0199.510.87
22970923-297092399.28099.73
32924353-292435397.72498.16
42974586-297458699.40399.87
52966449-296644999.13199.58
62999820-2999820100.246100.71
60min12974422-297442299.39799.480.5799.98100.080.57
22990346-299034699.929100.52
32955655-295565598.77099.35
42977632-297763299.505100.12
52962790-296279099.00999.61
63000590-3000590100.272100.88
极限12975311-297531199.42799.460.43100.16100.200.43
22989788-298978899.911100.66
32974389-297438999.396100.12
42969926-296992699.247100.01
52957342-295734298.82799.58
62990661-299066199.940100.70
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%
110.173031105302897630252603024256302555130270300.10
210.113034342302694830306450.18
单位质量响应值RSD%判断
297643.07299767.060.51数据可信
供试品溶液-25020301批-pH12.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1429321-42932114.31513.744.6714.3213.744.68
2436393-43639314.55114.55
3421254-42125414.04614.05
4400558-40055813.35613.36
5392219-39221913.07813.08
6393320-39332013.11513.11
10min1981705-98170532.73432.624.4632.7632.644.46
2987622-98762232.93232.95
31057037-105703735.24635.27
4960550-96055032.02932.05
5931746-93174631.06831.09
6951643-95164331.73231.75
15min11460723-146072348.70750.064.8448.7850.134.83
21502605-150260550.10350.17
31643784-164378454.81154.88
41488914-148891449.64749.71
51464081-146408148.81948.89
61447733-144773348.27448.34
20min11891677-189167763.07764.754.7563.2264.904.75
21950569-195056965.04065.19
32123975-212397570.82370.98
41905718-190571863.54563.69
51886446-188644662.90263.04
61893617-189361763.14163.28
30min12511534-251153483.74585.963.4283.9886.203.42
22592881-259288186.45886.70
32727369-272736990.94291.20
42469955-246995582.35982.60
52591442-259144286.41086.64
62574747-257474785.85386.09
45min12920570-292057097.38596.940.6897.7597.320.69
22924787-292478797.52597.90
32925722-292572297.55697.96
42876480-287648095.91496.28
52898572-289857296.65197.01
62898124-289812496.63697.00
60min12999212-2999212100.00798.580.92100.5299.100.91
22979315-297931599.34399.86
32941850-294185098.09498.64
42927402-292740297.61298.12
52945722-294572298.22398.73
62944899-294489998.19698.70
极限13006144-3006144100.23898.911.01100.9099.581.01
22977975-297797599.29999.97
32976380-297638099.24599.94
42924043-292404397.50098.15
52974877-297487799.19599.85
62938716-293871697.99098.64
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