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)0
对照品批号101028-202405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(%)98.4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%
111.121700771700941699241709451693131700710.35
211.121713201718571715880.23
单位质量响应值RSD%判断
15294.1515430.580.63数据可信
供试品溶液-CLB3645批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1125571-12557169.63972.707.1669.6472.707.16
2135340-13534075.05775.06
3143455-14345579.55779.56
4133118-13311873.82473.82
5115911-11591164.28264.28
6133151-13315173.84373.84
10min1164128-16412891.02291.951.3291.4192.351.34
2165876-16587691.99192.41
3170035-17003594.29894.74
4165355-16535591.70292.11
5164313-16431391.12491.48
6165069-16506991.54491.95
15min1172711-17271195.78298.222.0996.6799.142.08
2174142-17414296.57597.50
3180381-180381100.035101.00
4181550-181550100.684101.60
5179152-17915299.354100.22
6174758-17475896.91797.84
20min1171803-17180395.27897.651.7996.7099.111.77
2175183-17518397.15398.62
3177106-17710698.21999.74
4176495-17649597.88099.36
5181274-181274100.531101.95
6174565-17456596.81098.27
30min1169602-16960294.05897.772.3296.0199.772.28
2177398-17739898.381100.39
3176175-17617597.70399.77
4175905-17590597.55399.58
5182380-182380101.144103.12
6176276-17627697.75999.75
45min1170443-17044394.52497.152.5397.0099.702.48
2173558-17355896.25298.80
3176246-17624697.742100.35
4175162-17516297.14199.71
5183192-183192101.594104.13
6172482-17248295.65598.19
60min1170385-17038594.49296.532.4097.4999.612.36
2174078-17407896.54099.63
3179368-17936899.474102.63
4170885-17088594.76997.87
5178908-17890899.219102.32
6170684-17068494.65897.73
极限1168663-16866393.53795.802.1397.0699.422.10
2173174-17317496.03999.66
3174262-17426296.642100.35
4171014-17101494.84198.47
5179030-17903099.286102.94
6170306-17030694.44898.04
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)0
对照品批号R075K0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(%)99.8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%
111.051869341847331858271870651865481862210.52
211.141885181884681884930.02
单位质量响应值RSD%判断
16852.5816920.380.29数据可信
供试品溶液-CLB3645批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147942-4794225.50134.1224.4625.5034.1224.46
260575-6057532.22032.22
386689-8668946.11046.11
454330-5433028.89928.90
554912-5491229.20829.21
680420-8042042.77642.78
10min1149287-14928779.40782.634.7379.5582.824.77
2159193-15919384.67684.85
3164335-16433587.41187.67
4151196-15119680.42280.58
5146406-14640677.87478.04
6161662-16166285.98986.23
15min1185630-18563098.73899.991.5999.32100.641.61
2186989-18698999.461100.11
3190946-190946101.566102.31
4192037-192037102.146102.75
5184456-18445698.11398.71
6187860-18786099.924100.64
20min1186408-18640899.152101.711.37100.28102.911.37
2193103-193103102.713103.91
3190238-190238101.189102.49
4193373-193373102.856104.03
5191857-191857102.050103.19
6192347-192347102.311103.58
30min1185480-18548098.658101.921.82100.34103.681.80
2193940-193940103.158104.93
3189719-189719100.913102.78
4193657-193657103.008104.75
5194654-194654103.538105.24
6192173-192173102.218104.06
45min1187228-18722899.588100.891.17101.82103.221.13
2189551-189551100.824103.17
3187620-18762099.796102.23
4192357-192357102.316104.63
5192217-192217102.242104.52
6189069-189069100.567102.97
60min1185498-18549898.66899.760.93101.45102.650.96
2189423-189423100.755103.66
3189416-189416100.752103.73
4188141-188141100.074102.96
5185720-18572098.786101.64
6187077-18707799.508102.47
极限1183910-18391097.82398.910.92101.15102.360.89
2187657-18765799.816103.28
3184145-18414597.948101.49
4187224-18722499.586103.03
5187390-18739099.674103.07
6185400-18540098.616102.13
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)0
对照品批号101028-202405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(%)98.4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%
111.121714211713581713171709181715091713050.14
211.121693291691941692620.06
单位质量响应值RSD%判断
15405.1315221.400.85数据可信
供试品溶液-CLB3645批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1141379-14137978.65874.816.8378.6674.816.83
2121632-12163267.67267.67
3143923-14392380.07480.07
4126136-12613670.17870.18
5141268-14126878.59778.60
6132470-13247073.70273.70
10min1169441-16944194.27192.803.0494.7193.223.06
2161854-16185490.05090.43
3173201-17320196.36396.81
4160873-16087389.50489.89
5170790-17079095.02295.46
6164619-16461991.58892.00
15min1181424-181424100.93898.951.87101.9099.881.87
2180723-180723100.548101.42
3179604-17960499.926100.91
4172868-17286896.17897.06
5176955-17695598.45299.42
6175513-17551397.64998.57
20min1177325-17732598.65899.171.99100.18100.651.98
2180879-180879100.635102.07
3183463-183463102.073103.61
4174757-17475797.22998.65
5178651-17865199.395100.91
6174371-17437197.01498.47
30min1177256-17725698.61999.572.12100.69101.602.10
2183156-183156101.902103.90
3183352-183352102.011104.11
4175149-17514997.44799.41
5179965-179965100.126102.19
6174920-17492097.32099.32
45min1180151-180151100.23098.632.29102.85101.222.27
2180996-180996100.700103.26
3181273-181273100.854103.52
4172152-17215295.78098.28
5175679-17567997.742100.36
6173414-17341496.48299.02
60min1175597-17559797.69697.512.25100.87100.642.23
2179520-17952099.879103.00
3179841-179841100.057103.29
4170791-17079195.02298.06
5174750-17475097.225100.39
6171048-17104895.16598.24
极限1177026-17702698.49198.072.00102.21101.752.01
2179064-17906499.625103.30
3179485-17948599.859103.64
4170970-17097095.12298.68
5178234-17823499.163102.87
6172880-17288096.18599.79
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)0
对照品批号R075K0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(%)99.8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%
111.051862141871941869781876411868841869820.28
211.141859371859771859570.02
单位质量响应值RSD%判断
16921.4516692.730.97数据可信
供试品溶液-CLB3645批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182614-8261444.15236.1130.6144.1536.1130.61
238196-3819620.41420.41
383252-8325244.49344.49
444277-4427723.66323.66
581636-8163643.63043.63
675472-7547240.33540.34
10min1163418-16341887.33781.2912.8887.5881.4912.92
2118764-11876463.47263.59
3165618-16561888.51388.76
4137322-13732273.39173.52
5161984-16198486.57186.81
6165495-16549588.44788.67
15min1192387-192387102.82099.073.25103.5599.723.33
2176145-17614594.13994.61
3186513-18651399.680100.42
4180577-18057796.50897.05
5186742-18674299.803100.53
6189833-189833101.455102.17
20min1190616-190616101.873101.011.07103.17102.221.18
2185540-18554099.160100.15
3189653-189653101.359102.65
4187682-187682100.305101.38
5190026-190026101.558102.84
6190511-190511101.817103.10
30min1188910-188910100.961101.670.75102.83103.440.70
2191301-191301102.239103.78
3191563-191563102.379104.24
4190605-190605101.867103.50
5191023-191023102.091103.93
6188055-188055100.505102.35
45min1191137-191137102.152100.241.20104.58102.571.25
2186911-18691199.893102.00
3189348-189348101.196103.62
4185092-18509298.921101.12
5186589-18658999.721102.13
6186332-18633299.584101.99
60min1187053-18705399.96999.200.80102.97102.080.88
2184238-18423898.465101.13
3187683-187683100.306103.29
4184506-18450698.608101.36
5184452-18445298.579101.54
6185709-18570999.251102.21
极限1186972-18697299.92699.511.16103.48102.941.26
2183526-18352698.084101.29
3187334-187334100.119103.66
4183401-18340198.017101.31
5187919-187919100.432103.94
6188016-188016100.484103.99
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