依折麦布阿托伐他汀片项目信息
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对照品来源工作对照品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%
110.221700981704951706101707121705271704880.14
210.161700091712981706540.54
单位质量响应值RSD%判断
16681.8016796.650.49数据可信
供试品溶液-2023120822批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min140092-4009221.48530.8821.0021.4830.8821.01
255064-5506429.50829.51
368947-6894736.94836.95
447750-4775025.58925.59
569971-6997137.49737.50
663936-6393634.26334.26
10min1123378-12337866.11770.998.8266.2471.168.82
2139682-13968274.85475.02
3146415-14641578.46378.67
4123932-12393266.41466.56
5118997-11899763.76963.98
6142390-14239076.30676.50
15min1165871-16587188.88987.395.2689.3887.965.26
2169066-16906690.60191.18
3168041-16804190.05290.69
4152754-15275481.86082.37
5151697-15169781.29381.86
6171004-17100491.64092.25
20min1171495-17149591.90393.243.6992.8894.293.70
2178211-17821195.50296.58
3172500-17250092.44193.58
4168336-16833690.21091.18
5168573-16857390.33791.35
6184851-18485199.060100.18
30min1181182-18118297.09495.762.9698.5897.332.92
2179687-17968796.29397.91
3169995-16999591.09992.75
4177541-17754195.14396.61
5177656-17765695.20496.72
6186080-18608099.719101.39
45min1180313-18031396.62895.802.5298.6697.902.49
2175091-17509193.83095.98
3174338-17433893.42695.59
4175345-17534593.96695.96
5182205-18220597.64299.69
6185264-18526499.281101.51
60min1179109-17910995.98395.012.2198.5597.642.18
2178875-17887595.85898.53
3172916-17291692.66495.34
4178916-17891695.88098.40
5172019-17201992.18394.77
6181893-18189397.475100.25
极限1183618-18361898.39995.582.53101.5098.742.48
2173937-17393793.21196.41
3176705-17670594.69597.89
4173667-17366793.06796.12
5178484-17848495.64898.75
6183755-18375598.473101.79
依折麦布阿托伐他汀片项目信息
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%
111.141541571543061544291543381542431542950.07
211.071540771551781546280.51
单位质量响应值RSD%判断
13850.5413968.200.60数据可信
供试品溶液-2023120822批-阿托伐他汀-pH6.8(内含0.2%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1116214-11621469.01474.2316.0169.0174.2216.01
2138325-13832582.14582.14
3106280-10628063.11563.11
4100428-10042859.64059.64
5148941-14894188.44988.45
6139752-13975282.99282.99
10min1156691-15669193.05292.944.5893.4493.364.62
2162229-16222996.34096.80
3148308-14830888.07388.42
4149687-14968788.89289.22
5155226-15522692.18292.67
6166923-16692399.12899.59
15min1169158-169158100.45596.983.14101.3697.923.13
2162882-16288296.72897.72
3155535-15553592.36593.21
4164562-16456297.72698.55
5159760-15976094.87495.88
6167990-16799099.762100.77
20min1164006-16400697.39697.474.3198.8598.944.30
2166067-16606798.620100.15
3152142-15214290.35091.70
4166985-16698599.165100.53
5162031-16203196.22397.75
6173579-173579103.081104.65
30min1164280-16428097.55897.173.4399.5699.183.43
2162445-16244596.46998.55
3154146-15414691.54093.40
4168109-16810999.832101.75
5162494-16249496.49898.56
6170287-170287101.126103.26
45min1161790-16179096.08096.613.4098.6299.163.35
2155555-15555592.37794.99
3157498-15749893.53195.89
4168529-168529100.082102.56
5163819-16381997.28599.89
6168869-168869100.284102.98
60min1160777-16077795.47895.522.9198.5598.602.87
2160236-16023695.15798.28
3156198-15619892.75995.64
4167072-16707299.217102.25
5155482-15548292.33495.48
6165267-16526798.145101.40
极限1163056-16305696.83296.402.47100.44100.012.41
2159351-15935194.63198.29
3160345-16034595.22298.62
4168497-168497100.063103.64
5157677-15767793.63797.29
6165005-16500597.989101.79
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