依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.872054412054512043692042932041182047340.33
211.842036012035082035540.04
单位质量响应值RSD%判断
17248.0217192.060.23数据可信
供试品溶液-X027068批-依折麦布-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min110359-103595.4015.773.625.405.783.65
211427-114275.9575.96
310865-108655.6645.66
411197-111975.8375.84
511280-112805.8815.88
611333-113335.9085.91
10min116932-169328.8279.092.248.869.122.23
217964-179649.3659.40
317162-171628.9478.98
417554-175549.1529.18
517763-177639.2619.29
617265-172659.0019.03
15min117553-175539.1519.161.099.239.241.07
217692-176929.2249.31
317822-178229.2919.37
417516-175169.1329.22
517594-175949.1729.26
617251-172518.9949.08
20min117137-171378.9348.970.769.069.100.76
217254-172548.9959.13
317081-170818.9059.04
417074-170748.9019.04
517406-174069.0749.21
617268-172689.0039.14
30min116878-168788.7998.861.188.989.051.18
216959-169598.8419.03
317163-171638.9489.13
417011-170118.8699.05
517287-172879.0129.20
616727-167278.7208.90
45min116735-167358.7258.661.548.958.891.52
216897-168978.8099.04
316155-161558.4228.65
416634-166348.6728.90
516726-167268.7208.96
616537-165378.6218.85
60min116971-169718.8488.602.099.128.882.03
216655-166558.6838.97
316198-161988.4458.72
416252-162528.4738.75
516788-167888.7529.04
616168-161688.4298.71
极限117028-170288.8778.582.079.208.901.99
216475-164758.5898.92
316335-163358.5168.84
416064-160648.3758.70
516607-166078.6588.99
616207-162078.4498.78
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.921542211548141538701538001537371540880.29
211.011532941535011533980.10
单位质量响应值RSD%判断
14110.6213932.610.90数据可信
供试品溶液-X027068批-阿托伐他汀钙-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min154447-5444732.07634.4418.8032.0834.4418.80
273162-7316243.10143.10
350926-5092630.00130.00
451377-5137730.26730.27
571771-7177142.28142.28
649116-4911628.93528.93
10min1131309-13130977.35680.014.7377.5380.204.76
2145406-14540685.66185.90
3130263-13026376.74076.91
4130963-13096377.15277.32
5142002-14200283.65583.89
6134914-13491479.48079.64
15min1156713-15671392.32293.181.5392.9393.821.52
2159405-15940593.90894.62
3161984-16198495.42796.02
4158677-15867793.47994.08
5157183-15718392.59993.30
6155043-15504391.33891.94
20min1159132-15913293.74795.981.3794.8797.141.37
2163783-16378396.48797.72
3165478-16547897.48598.61
4163867-16386796.53697.65
5163659-16365996.41497.63
6161637-16163795.22396.33
30min1162729-16272995.86697.701.9297.5199.391.89
2165094-16509497.25999.03
3171097-171097100.796102.46
4167992-16799298.966100.62
5165054-16505497.23698.99
6163128-16312896.10197.74
45min1164212-16421296.74097.561.6798.9199.791.64
2166738-16673898.228100.54
3164249-16424996.76198.99
4170699-170699100.561102.76
5164499-16449996.90999.20
6163245-16324596.17098.34
60min1166895-16689598.32097.831.22101.03100.601.18
2164676-16467697.01399.87
3167838-16783898.876101.64
4168265-16826599.127101.89
5165674-16567497.601100.43
6162987-16298796.01898.72
极限1168337-16833799.17098.221.07102.43101.531.03
2166035-16603597.814101.21
3169112-16911299.626102.94
4167034-16703498.402101.71
5165293-16529397.376100.75
6164497-16449796.908100.15
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