依折麦布瑞舒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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.871653491658101656941658611652461655920.17
210.931675061667231671140.34
单位质量响应值RSD%判断
15233.8515289.480.26数据可信
供试品溶液-CLB03646批-瑞舒伐他汀钙-pH4.5(内含%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1115522-11552264.81571.717.7564.8271.717.75
2119238-11923866.90066.90
3127621-12762171.60471.60
4127288-12728871.41771.42
5134462-13446275.44275.44
6142689-14268980.05880.06
10min1161539-16153990.63491.662.7490.9992.062.75
2160950-16095090.30390.68
3157644-15764488.44988.85
4163977-16397792.00292.40
5165449-16544992.82893.25
6170640-17064095.74096.18
15min1172671-17267196.88096.203.2897.7497.113.27
2172050-17205096.53197.40
3160666-16066690.14491.03
4174942-17494298.15499.06
5171817-17181796.40197.34
6176629-17662999.100100.08
20min1176682-17668299.13098.184.03100.5399.624.01
2172885-17288597.00098.41
3163048-16304891.48192.87
4180642-180642101.352102.81
5173639-17363997.42398.89
6183024-183024102.688104.22
30min1176442-17644298.99597.353.27100.9599.343.26
2171606-17160696.28298.23
3164154-16415492.10194.00
4178205-17820599.985102.00
5171334-17133496.13098.14
6179326-179326100.614102.71
45min1174928-17492898.14696.863.41100.6599.393.39
2172050-17205096.53199.01
3162421-16242191.12993.54
4177107-17710799.369101.94
5170519-17051995.67298.22
6178810-178810100.324102.98
60min1172273-17227396.65696.882.2099.7099.952.23
2170056-17005695.41398.43
3167546-16754694.00496.92
4175633-17563398.542101.67
5172420-17242096.73999.82
6178117-17811799.935103.15
极限1172740-17274096.91895.663.83100.5099.273.78
2168410-16841094.48998.04
3160837-16083790.24093.68
4179436-179436100.675104.35
5166918-16691893.65297.27
6174661-17466197.996101.77
依折麦布瑞舒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%
110.941876841865661873701868021864621869770.29
210.991876491873951875220.10
单位质量响应值RSD%判断
17091.1317062.970.12数据可信
供试品溶液-CLB03646批-依折麦布-pH4.5(内含%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min167796-6779635.64135.7716.4235.6435.7616.43
271515-7151537.59637.60
377198-7719840.58340.58
446079-4607924.22424.22
572973-7297338.36238.36
672642-7264238.18838.19
10min1152058-15205879.93884.637.9180.1484.837.91
2157874-15787482.99583.20
3164329-16432986.38986.61
4145545-14554576.51476.65
5182513-18251395.94896.16
6163626-16362686.01986.23
15min1182792-18279296.09595.521.0496.7496.191.02
2183495-18349596.46497.13
3179733-17973394.48795.19
4180535-18053594.90895.47
5179854-17985494.55095.30
6183832-18383296.64297.33
20min1187327-18732798.47998.792.1099.6599.992.06
2187248-18724898.43799.64
3182419-18241995.89997.13
4189824-18982499.792100.88
5186416-18641698.00099.27
6194273-194273102.130103.36
30min1189175-18917599.45098.221.21101.1799.961.16
2183677-18367796.56098.31
3186239-18623997.90799.67
4188562-18856299.128100.77
5184861-18486197.18399.00
6188447-18844799.068100.86
45min1185872-18587297.71497.711.4999.99100.001.42
2186376-18637697.979100.27
3183056-18305696.23498.54
4189341-18934199.538101.73
5182328-18232895.85198.21
6188169-18816998.922101.27
60min1185325-18532597.42698.221.23100.24101.051.20
2185965-18596597.763100.60
3191164-191164100.496103.34
4185983-18598397.772100.52
5185045-18504597.279100.17
6187472-18747298.555101.45
极限1185385-18538597.45896.461.92100.8299.841.82
2180174-18017494.71998.10
3183511-18351196.47399.87
4188158-18815898.916102.20
5178663-17866393.92497.35
6184991-18499197.251100.69
依折麦布瑞舒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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.871646261644751649681647751657101649110.30
210.931657301674081665690.72
单位质量响应值RSD%判断
15171.2115239.620.32数据可信
供试品溶液-CLB03646批-瑞舒伐他汀钙-pH4.5(内含%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1134807-13480775.91571.047.6575.9271.047.66
2126086-12608671.00471.00
3125263-12526370.54170.54
4138060-13806077.74777.75
5111061-11106162.54362.54
6121649-12164968.50668.51
10min1166940-16694094.01191.662.5594.4392.062.57
2159618-15961889.88890.28
3164583-16458392.68493.08
4165152-16515293.00493.44
5155916-15591687.80388.15
6164421-16442192.59292.97
15min1172851-17285197.34095.791.1698.2896.701.17
2168828-16882895.07495.97
3168445-16844594.85895.77
4170301-17030195.90496.85
5168177-16817794.70895.54
6172002-17200296.86297.76
20min1178053-178053100.26997.301.75101.7598.731.75
2173047-17304797.45098.87
3173867-17386797.91299.35
4170562-17056296.05197.53
5169746-16974695.59196.95
6171360-17136096.50097.93
30min1171305-17130596.46995.650.9598.5197.620.94
2167063-16706394.08096.04
3169414-16941495.40497.38
4169383-16938395.38797.40
5170709-17070996.13398.03
6171199-17119996.40998.38
45min1174874-17487498.47996.051.60101.0698.561.58
2168089-16808994.65897.14
3167538-16753894.34896.86
4170136-17013695.81198.36
5172266-17226697.01099.44
6170425-17042595.97398.48
60min1174375-17437598.19894.612.04101.3297.662.01
2166365-16636593.68796.70
3168373-16837394.81897.85
4164807-16480792.81095.89
5165858-16585893.40296.37
6168286-16828694.76997.81
极限1164511-16451192.64392.741.4696.3196.311.37
2166628-16662893.83597.37
3163586-16358692.12295.68
4160815-16081590.56294.15
5167618-16761894.39397.88
6164958-16495892.89596.46
依折麦布瑞舒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%
110.941834151842211833091843291851541840860.41
210.991834071853831843950.76
单位质量响应值RSD%判断
16826.8716778.430.21数据可信
供试品溶液-CLB03646批-依折麦布-pH4.5(内含%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min183438-8343844.58039.0217.8844.5839.0217.88
266385-6638535.46935.47
354034-5403428.87028.87
491035-9103548.63948.64
574043-7404339.56139.56
669302-6930237.02737.03
10min1159083-15908384.99782.903.1985.2483.123.22
2155562-15556283.11583.31
3151113-15111380.73880.90
4161873-16187386.48786.76
5148441-14844179.31179.53
6154925-15492582.77582.98
15min1185438-18543899.07896.662.0199.8097.342.03
2181116-18111696.76997.43
3178729-17872995.49396.10
4184441-18444198.54599.30
5175701-17570193.87694.54
6180040-18004096.19496.86
20min1191959-191959102.56299.552.12103.83100.762.11
2187650-187650100.260101.46
3188531-188531100.731101.87
4184396-18439698.52199.82
5180541-18054196.46297.64
6184802-18480298.73899.94
30min1184802-18480298.73898.761.30100.58100.521.28
2181232-18123296.83198.58
3186937-18693799.879101.58
4185272-18527298.989100.83
5183077-18307797.81799.53
6187696-187696100.284102.03
45min1194066-194066103.68899.932.26106.08102.242.26
2181271-18127196.85299.14
3185485-18548599.103101.36
4188312-188312100.614103.01
5185516-18551699.120101.38
6187514-187514100.187102.49
60min1193444-193444103.356100.872.99106.32103.742.92
2181675-18167597.06799.90
3188538-188538100.734103.54
4183453-18345398.017100.97
5189232-189232101.105103.92
6196398-196398104.934107.80
极限1177969-17796995.08798.542.6798.63101.972.55
2180716-18071696.55599.92
3191829-191829102.493105.86
4187261-187261100.052103.55
5185564-18556499.145102.52
6183228-18322897.897101.34
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