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%
110.221691681693281702881702181711611700330.48
210.161705501711061708280.24
单位质量响应值RSD%判断
16637.2816813.780.75数据可信
供试品溶液-2023121221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%
5min143695-4369523.43523.3612.0923.4423.3612.08
238550-3855020.67620.68
349693-4969326.65226.65
436049-3604919.33419.33
546973-4697325.19325.19
646314-4631424.84024.84
10min1119445-11944564.06366.286.0464.1966.406.05
2116535-11653562.50262.62
3132213-13221370.91171.06
4114957-11495761.65661.76
5129590-12959069.50469.64
6128689-12868969.02169.16
15min1155527-15552783.41585.543.4983.9086.043.51
2157847-15784784.65985.12
3166727-16672789.42289.96
4151513-15151381.26281.71
5162366-16236687.08387.61
6162942-16294287.39287.91
20min1172654-17265492.60192.951.9593.5593.921.95
2170985-17098591.70692.64
3169032-16903290.65891.70
4172518-17251892.52893.43
5177517-17751795.20996.22
6177124-17712494.99896.01
30min1175673-17567394.22096.221.0895.6897.711.07
2179939-17993996.50897.95
3179147-17914796.08397.63
4180329-18032996.71798.13
5180349-18034996.72898.27
6180957-18095797.05498.59
45min1185955-18595599.73597.292.77101.7299.322.68
2186948-186948100.267102.25
3173236-17323692.91394.99
4180223-18022396.66198.61
5182775-18277598.029100.11
6179295-17929596.16398.24
60min1178941-17894195.97394.321.9198.5196.881.87
2177205-17720595.04297.58
3170775-17077591.59394.19
4172536-17253692.53895.03
5177716-17771695.31697.94
6177935-17793595.43398.04
极限1171950-17195092.22394.201.3095.3097.291.29
2174964-17496493.84096.90
3176352-17635294.58497.69
4175573-17557394.16797.17
5178987-17898795.99899.15
6176033-17603394.41397.55
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2500
标示量(mg)20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%
111.143001563008453019623021683033743017010.42
211.073038743056803047770.42
单位质量响应值RSD%判断
27082.6827531.801.17数据可信
供试品溶液-2023121221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%
5min1233037-23303770.49562.7525.6970.4962.7525.69
2137318-13731841.53941.54
3145128-14512843.90243.90
4238060-23806072.01472.01
5266762-26676280.69780.70
6224340-22434067.86467.86
10min1309316-30931693.56988.838.9293.9689.178.98
2259260-25926078.42778.66
3262103-26210379.28779.53
4300041-30004190.76491.16
5315333-31533395.39095.84
6315745-31574595.51495.89
15min1314410-31441095.11093.193.5696.0294.033.66
2292408-29240888.45589.12
3297352-29735289.95090.63
4313658-31365894.88395.79
5309533-30953393.63594.61
6321003-32100397.10598.01
20min1324091-32409198.03995.864.0799.4897.224.15
2304194-30419492.02093.18
3297975-29797590.13991.32
4323517-32351797.86599.30
5320426-32042696.93098.43
6331119-331119100.165101.61
30min1317008-31700895.89696.892.3397.8898.792.41
2311028-31102894.08795.76
3315509-31550995.44397.13
4328760-32876099.451101.43
5319963-31996396.79098.83
6329555-32955599.692101.70
45min1324995-32499598.31297.612.20100.83100.042.23
2327412-32741299.044101.24
3308706-30870693.38595.60
4327678-32767899.124101.65
5323177-32317797.762100.34
6324121-32412198.048100.61
60min1319344-31934496.60394.951.3899.6797.921.49
2312024-31202494.38997.13
3306838-30683892.82095.55
4313851-31385194.94198.02
5314233-31423395.05798.17
6317010-31701095.89799.00
极限1306100-30610092.59795.291.7296.2098.791.67
2310788-31078894.01597.28
3319145-31914596.54399.79
4319049-31904996.514100.12
5316284-31628495.67799.32
6318672-31867296.400100.03
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