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%
110.112917359292447529199282922876292305829215390.10
210.172894058289675628954070.07
单位质量响应值RSD%判断
288975.17284700.791.06数据可信
供试品溶液-25010201批-shui(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1701843-70184324.37223.912.4024.3723.912.39
2664256-66425623.06723.07
3699707-69970724.29824.30
4694484-69448424.11624.12
5699365-69936524.28624.29
6670881-67088123.29723.30
10min11423744-142374449.44048.622.0149.4848.652.01
21347540-134754046.79446.83
31413020-141302049.06849.10
41420054-142005449.31249.35
51402288-140228848.69548.73
61393316-139331648.38348.42
15min11943325-194332567.48366.471.6967.5966.571.69
21852452-185245264.32764.43
31927462-192746266.93267.04
41931686-193168667.07867.19
51908316-190831666.26766.38
61920945-192094566.70666.81
20min12261920-226192078.54677.691.1978.7677.901.19
22188319-218831975.99076.19
32240801-224080177.81378.02
42258425-225842578.42578.64
52233473-223347377.55877.77
62240668-224066877.80878.02
30min12553676-255367688.67788.190.7089.0188.510.70
22510565-251056587.18087.50
32530644-253064487.87888.20
42560247-256024788.90689.23
52540622-254062288.22488.55
62541742-254174288.26388.59
45min12737864-273786495.07394.170.8495.5494.630.85
22680715-268071593.08993.53
32696469-269646993.63694.09
42737911-273791195.07595.54
52711749-271174994.16694.62
62707209-270720994.00994.47
60min12832282-283228298.35296.891.0198.9697.491.02
22755517-275551795.68696.27
32766433-276643396.06596.66
42810256-281025697.58798.19
52791403-279140396.93297.53
62785697-278569796.73497.33
极限12850661-285066198.99098.200.8099.7498.950.80
22810872-281087297.60998.34
32797442-279744297.14297.89
42854946-285494699.13999.89
52822360-282236098.00798.75
62831437-283143798.32399.07
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%
110.112897787289590928982592902591289912028987330.09
210.172871737288508628784120.33
单位质量响应值RSD%判断
286719.39283029.700.92数据可信
供试品溶液-25010201批-pH4.5(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1386563-38656313.51613.033.7213.5213.033.73
2362576-36257612.67712.68
3379416-37941613.26613.27
4351572-35157212.29212.29
5370017-37001712.93712.94
6385409-38540913.47613.48
10min1866872-86687230.31029.662.6930.3329.682.69
2824917-82491728.84328.86
3843766-84376629.50229.52
4821319-82131928.71728.74
5878667-87866730.72230.74
6854515-85451529.87729.90
15min11315374-131537445.99144.322.0046.0644.382.00
21244172-124417243.50243.56
31267905-126790544.33144.40
41250870-125087043.73643.80
51258287-125828743.99544.06
61268345-126834544.34744.41
20min11675385-167538558.57956.911.5758.7157.041.56
21605708-160570856.14256.27
31634033-163403357.13357.26
41612981-161298156.39756.52
51613216-161321656.40556.54
61625108-162510856.82156.95
30min12173516-217351675.99575.061.0376.2275.281.03
22132450-213245074.55974.77
32173742-217374276.00376.22
42146109-214610975.03775.25
52128591-212859174.42574.64
62126171-212617174.34074.56
45min12586107-258610790.42190.200.6190.7690.530.61
22569396-256939689.83790.16
32608898-260889891.21891.55
42572191-257219189.93590.26
52574623-257462390.02090.35
62567590-256759089.77490.10
60min12759057-275905796.46896.270.4896.9496.740.48
22767100-276710096.75097.21
32764857-276485796.67197.14
42754586-275458696.31296.77
52736374-273637495.67596.14
62739004-273900495.76796.23
极限12834402-283440299.10399.020.3799.7299.630.36
22847026-284702699.544100.15
32837552-283755299.21399.82
42831669-283166999.00799.61
52822173-282217398.67599.28
62819314-281931498.57599.18
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