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%
110.173021057302599330265343019812302189530230580.11
210.113017728303041230240700.30
单位质量响应值RSD%判断
297252.51299116.720.45数据可信
供试品溶液-23004N1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%
5min1783361-78336126.16620.3515.0526.1720.3515.06
2554190-55419018.51118.51
3569259-56925919.01519.01
4542202-54220218.11118.11
5638118-63811821.31521.31
6567875-56787518.96818.97
10min11485837-148583749.63141.5810.2449.6741.6110.24
21159748-115974838.73838.77
31186475-118647539.63139.66
41151350-115135038.45838.49
51285388-128538842.93542.97
61199217-119921740.05740.09
15min12059649-205964968.79759.498.2168.9159.588.22
21682126-168212656.18756.27
31722784-172278457.54557.63
41669281-166928155.75855.84
51817274-181727460.70160.80
61735009-173500957.95458.04
20min12467887-246788782.43372.896.6382.6573.076.64
22085605-208560569.66469.83
32108262-210826270.42170.60
42098315-209831570.08970.26
52184303-218430372.96173.15
62148564-214856471.76771.94
30min12839366-283936694.84289.992.7395.1890.282.75
22650611-265061188.53788.81
32669255-266925589.16089.44
42649594-264959488.50388.78
52656644-265664488.73889.04
62699621-269962190.17490.46
45min12945638-294563898.39297.391.3098.8797.821.30
22883287-288328796.30996.72
32973786-297378699.33299.75
42882044-288204496.26796.67
52890705-289070596.55796.99
62918472-291847297.48497.90
60min12946053-294605398.40597.971.1199.0498.541.12
22907060-290706097.10397.65
32991223-299122399.914100.48
42905242-290524297.04297.59
52916703-291670397.42598.00
62932381-293238197.94998.51
极限12956151-295615198.74398.901.5599.5299.621.54
22945700-294570098.39499.09
33052697-3052697101.968102.68
42934623-293462398.02498.72
52940799-294079998.23098.95
62935567-293556798.05598.77
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%
110.173022499302098130212633023275302110630218250.04
210.113011385301160130114930.01
单位质量响应值RSD%判断
297131.27297872.700.18数据可信
供试品溶液-23004N1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%
5min1649846-64984621.75623.858.4321.7623.858.43
2775292-77529225.95625.96
3716346-71634623.98223.98
4738513-73851324.72524.72
5763871-76387125.57325.57
6629910-62991021.08921.09
10min11263600-126360042.30446.007.2542.3446.047.25
21471679-147167949.27049.31
31325067-132506744.36244.40
41441516-144151648.26048.30
51473394-147339449.32749.37
61269019-126901942.48542.52
15min11798422-179842260.20964.636.6860.3164.746.68
22064942-206494269.13269.24
31843679-184367961.72461.83
42011123-201112367.33067.44
52061759-206175969.02569.14
61802741-180274160.35460.45
20min12231845-223184574.72078.274.8274.9178.474.83
22452850-245285082.11982.34
32222234-222223474.39874.59
42410213-241021380.69180.90
52454082-245408282.16082.38
62255258-225525875.50375.69
30min12750171-275017192.07292.831.9992.3793.152.00
22839468-283946895.06295.40
32706750-270675090.61990.93
42813598-281359894.19694.53
52807695-280769593.99894.34
62719103-271910391.03291.33
45min12928626-292862698.04798.390.5898.4898.850.60
22967837-296783799.36099.84
32919636-291963697.74698.19
42932009-293200998.16098.63
52947515-294751598.67999.16
62937370-293737098.34098.78
60min12943162-294316298.53499.540.9499.12100.140.94
22984640-298464099.922100.55
33021099-3021099101.143101.73
42972623-297262399.520100.14
52965343-296534399.27699.90
62951671-295167198.81899.40
极限12960911-296091199.12899.540.5599.86100.290.57
23002951-3002951100.535101.32
32957307-295730799.00799.75
42968341-296834199.377100.15
52977400-297740099.680100.46
62971784-297178499.492100.22
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%
110.173027579302594330226343020897302381830241740.09
210.113020584301910430198440.04
单位质量响应值RSD%判断
297362.24298698.710.32数据可信
供试品溶液-24123101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%
5min1635242-63524221.23019.4212.0521.2319.4212.05
2523414-52341417.49217.49
3522761-52276117.47017.47
4580164-58016419.38919.39
5692830-69283023.15423.15
6532524-53252417.79717.80
10min11395809-139580946.64743.747.9446.6843.767.95
21211978-121197840.50440.53
31228390-122839041.05241.08
41284389-128438942.92442.95
51474037-147403749.26249.30
61257566-125756642.02742.05
15min12011350-201135067.21863.845.7667.3263.945.77
21836403-183640361.37261.46
31799973-179997360.15460.24
41873689-187368962.61862.71
52080093-208009369.51669.62
61860700-186070062.18462.27
20min12480633-248063382.90279.213.7283.1079.403.72
22360573-236057378.88979.07
32303540-230354076.98377.16
42280350-228035076.20876.40
52477028-247702882.78182.99
62319618-231961877.52177.70
30min13014220-3014220100.73496.522.62101.0696.832.62
22922701-292270197.67597.97
32840078-284007894.91495.21
42800937-280093793.60693.91
52900000-290000096.91797.25
62851233-285123395.28795.59
45min12988446-298844699.873100.401.04100.35100.851.04
23028047-3028047101.196101.64
33008185-3008185100.532100.97
42950616-295061698.60899.05
53012336-3012336100.671101.15
63037474-3037474101.511101.95
60min12996482-2996482100.141101.001.87100.77101.601.86
23126641-3126641104.491105.09
33014509-3014509100.744101.33
42964684-296468499.07899.67
52994272-2994272100.067100.70
63036233-3036233101.470102.06
极限12994709-2994709100.082100.320.49100.86101.080.49
23025564-3025564101.113101.87
33011581-3011581100.646101.38
42989973-298997399.924100.66
53001310-3001310100.302101.09
62987454-298745499.839100.59
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%
110.173020239301899130173523011566301168130159660.14
210.113025759302160730236830.10
单位质量响应值RSD%判断
296555.16299078.440.60数据可信
供试品溶液-24123102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%
5min1501889-50188916.78517.402.9716.7917.402.97
2543886-54388618.19018.19
3509108-50910817.02717.03
4527136-52713617.63017.63
5527744-52774417.65017.65
6511906-51190617.12017.12
10min11130884-113088437.82140.413.8837.8540.433.88
21239550-123955041.45541.48
31200201-120020140.13940.17
41216863-121686340.69740.72
51268578-126857842.42642.45
61192828-119282839.89339.92
15min11678398-167839856.13259.363.1056.2159.453.10
21835440-183544061.38461.47
31760359-176035958.87358.96
41779084-177908459.50059.59
51818563-181856360.82060.91
61777723-177772359.45459.54
20min12126089-212608971.10574.682.7871.2774.862.78
22303925-230392577.05277.23
32219498-221949874.22974.40
42228100-222810074.51774.69
52283763-228376376.37876.56
62237016-223701674.81574.99
30min12756369-275636992.18493.331.4292.4693.621.42
22838670-283867094.93695.23
32794714-279471493.46693.75
42740140-274014091.64191.93
52831624-283162494.70195.00
62782410-278241093.05593.34
45min12955426-295542698.84199.090.8399.2599.520.83
22999430-2999430100.313100.75
32965745-296574599.18699.61
42959733-295973398.98599.41
52972708-297270899.41999.86
62924249-292424997.79998.23
60min12949683-294968398.64999.180.8799.2199.750.87
23011920-3011920100.731101.32
32965691-296569199.18599.76
42962066-296206699.06399.64
52966754-296675499.22099.81
62936364-293636498.20498.78
极限12943651-294365198.44799.000.9199.1599.730.91
22992142-2992142100.069100.81
32979247-297924799.638100.36
42967495-296749599.24599.97
52962267-296226799.07099.81
62917048-291704897.55898.28
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