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DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67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%
110.021691901690581687831686791681401687700.25
210.031687961692321690140.19
单位质量响应值RSD%判断
16843.3116850.850.04数据可信
供试品溶液-2024011223批-依折麦布-pH6.8(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%
5min154633-5463329.09036.6621.8129.0936.6621.81
266808-6680835.57235.57
350528-5052826.90426.90
470451-7045137.51237.51
589704-8970447.76347.76
681003-8100343.13043.13
10min1154284-15428482.14982.136.1782.3182.336.19
2154414-15441482.21882.42
3140348-14034874.72974.88
4147449-14744978.51078.72
5165650-16565088.20188.47
6163306-16330686.95387.19
15min1179360-17936095.50193.612.6796.1294.272.70
2174513-17451392.92093.57
3168688-16868889.81990.38
4172908-17290892.06692.71
5177934-17793494.74295.50
6181444-18144496.61197.33
20min1184080-18408098.01497.511.7499.1698.691.79
2182709-18270997.28498.45
3179654-17965495.65896.72
4180071-18007195.88097.04
5188374-188374100.301101.58
6183899-18389997.91899.18
30min1186536-18653699.322100.181.68101.01101.901.73
2185745-18574598.901100.61
3184175-18417598.06599.66
4189885-189885101.105102.79
5192533-192533102.515104.35
6189957-189957101.143102.95
45min1186917-18691799.52599.470.84101.77101.750.89
2186161-18616199.122101.38
3186129-18612999.105101.25
4185193-18519398.607100.86
5189740-189740101.028103.44
6186772-18677299.448101.81
60min1184505-18450598.24099.520.99101.04102.351.02
2188626-188626100.435103.25
3186126-18612699.104101.79
4185379-18537998.706101.50
5187688-18768899.935102.91
6189082-189082100.678103.60
极限1186411-18641199.25599.212.13102.60102.592.15
2184002-18400297.973101.34
3182657-18265797.257100.50
4182909-18290997.391100.74
5192549-192549102.524106.05
6189386-189386100.839104.32
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%
111.171591801586281588611584381586041587420.19
211.111585611592371588990.31
单位质量响应值RSD%判断
14211.4614302.340.46数据可信
供试品溶液-2024011223批-阿托伐他汀钙-pH6.8(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%
5min1144147-14414783.51582.0010.3983.5282.0010.39
2115907-11590767.15467.15
3133226-13322677.18877.19
4148932-14893286.28786.29
5155377-15537790.02190.02
6151625-15162587.84887.85
10min1163478-16347894.71596.402.1595.1896.862.17
2165437-16543795.85096.22
3161203-16120393.39793.83
4169559-16955998.23898.72
5169606-16960698.26598.77
6169070-16907097.95598.44
15min1169084-16908497.96397.251.8798.9598.241.88
2166139-16613996.25797.16
3164225-16422595.14896.10
4171381-17138199.294100.32
5165066-16506695.63596.68
6171187-17118799.181100.21
20min1167440-16744097.01097.401.0098.5498.931.03
2167089-16708996.80798.25
3165754-16575496.03497.51
4170175-17017598.595100.17
5169663-16966398.29899.88
6168569-16856997.66599.25
30min1166112-16611296.24197.552.5098.3199.622.51
2163737-16373794.86596.84
3164401-16440195.25097.26
4174075-174075100.855102.98
5170683-17068398.889101.01
6171211-17121199.195101.32
45min1165374-16537495.81396.201.0798.4298.811.11
2164019-16401995.02897.53
3164210-16421095.13997.68
4168285-16828597.500100.18
5166936-16693696.71899.39
6167390-16739096.98299.66
60min1162899-16289994.38096.181.5397.5299.331.53
2166195-16619596.28999.32
3163981-16398195.00698.07
4168528-16852897.641100.87
5165093-16509395.65198.86
6169359-16935998.122101.34
极限1164623-16462395.37895.752.1399.0499.442.13
2161858-16185893.77697.34
3160947-16094793.24996.84
4165843-16584396.08599.85
5169134-16913497.992101.73
6169231-16923198.048101.81
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