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%
110.951703711698341700081705851703511702300.18
211.031696451695071695760.06
单位质量响应值RSD%判断
15546.1215374.070.79数据可信
供试品溶液-2023122321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%
5min1144228-14422879.88580.497.4579.8880.497.44
2152669-15266984.56084.56
3135454-13545475.02575.03
4129668-12966871.82071.82
5154102-15410285.35485.35
6155815-15581586.30386.30
10min1174706-17470696.76695.251.9297.2195.701.94
2172029-17202995.28395.75
3168992-16899293.60194.02
4167019-16701992.50892.91
5174448-17444896.62397.10
6174631-17463196.72597.20
15min1177027-17702798.05296.931.1699.0397.901.18
2174406-17440696.60097.60
3173245-17324595.95796.89
4172255-17225595.40896.32
5177102-17710298.09399.10
6175984-17598497.47498.49
20min1179568-17956899.45997.702.51100.9999.222.51
2173045-17304595.84697.38
3172956-17295695.79797.27
4171422-17142294.94796.39
5181865-181865100.731102.29
6179538-17953899.442101.00
30min1176118-17611897.54896.612.3099.6398.672.26
2168143-16814393.13195.20
3170751-17075194.57596.58
4177808-17780898.484100.45
5177583-17758398.360100.48
6176139-17613997.56099.67
45min1174378-17437896.58496.992.6999.2099.592.65
2168363-16836393.25395.84
3171894-17189495.20997.74
4175525-17552597.22099.74
5180784-180784100.133102.79
6179758-17975899.564102.22
60min1173187-17318795.92595.581.9399.0898.721.92
2168383-16838393.26496.37
3169141-16914193.68496.74
4173244-17324495.95699.01
5177321-17732198.214101.43
6174165-17416596.46699.67
极限1174305-17430596.54496.681.54100.23100.351.51
2172519-17251995.55599.18
3171674-17167495.08798.66
4177970-17797098.574102.16
5177713-17771398.432102.20
6173152-17315295.90599.65
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ZT-705-231101-1-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(%)100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%
111.061800461804261797901794811800191799520.20
211.131779321787951783640.35
单位质量响应值RSD%判断
16270.5216025.521.08数据可信
供试品溶液-2023122321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%
5min193418-9341852.06956.0311.4652.0756.0311.46
2111946-11194662.39662.40
398506-9850654.90554.90
481983-8198345.69545.70
5109723-10972361.15761.16
6107576-10757659.96059.96
10min1157539-15753987.80890.011.9188.1090.321.93
2163311-16331191.02691.37
3162434-16243490.53790.84
4158137-15813788.14288.40
5165498-16549892.24592.58
6161969-16196990.27890.61
15min1168195-16819593.74895.841.2394.5296.651.23
2172195-17219595.97796.83
3173688-17368896.81097.62
4173590-17359096.75597.50
5173079-17307996.47097.32
6170959-17095995.28896.12
20min1174936-17493697.50597.981.4598.8099.331.44
2172433-17243396.11097.50
3175843-17584398.01199.36
4174993-17499397.53798.82
5180178-180178100.427101.82
6176369-17636998.30499.67
30min1178104-17810499.27197.821.22101.1199.711.17
2173978-17397896.97198.89
3172898-17289896.36998.26
4178040-17804099.235101.06
5175152-17515297.62699.57
6174835-17483597.44999.36
45min1175560-17556097.85398.321.28100.24100.761.27
2174393-17439397.20299.66
3174026-17402696.99899.42
4176211-17621198.216100.59
5178846-17884699.684102.17
6179406-17940699.997102.45
60min1174272-17427297.13596.870.72100.0799.840.73
2173909-17390996.93399.93
3172645-17264596.22899.19
4173096-17309696.48099.40
5175997-17599798.096101.14
6172839-17283996.33699.34
极限1178037-17803799.23498.211.41102.71101.721.34
2177503-17750398.936102.47
3174399-17439997.206100.71
4178602-17860299.548103.00
5176500-17650098.377101.96
6172122-17212295.93799.48
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