瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101028-202405对照品来源中检所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)20供试品稀释倍数10系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.052545472548422552492551092555622550620.16
211.152558092561342559720.09
单位质量响应值RSD%判断
23082.5322957.130.39数据可信
供试品溶液-WK0055批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1166263-16626361.53366.884.3461.5366.884.34
2182223-18222367.44067.44
3186963-18696369.19469.19
4180037-18003766.63166.63
5188163-18816369.63869.64
6180567-18056766.82766.83
10min1201501-20150174.57574.852.4575.2675.592.44
2209208-20920877.42778.18
3204783-20478375.78976.56
4198741-19874173.55374.29
5204089-20408975.53276.31
6195122-19512272.21472.96
15min1203962-20396275.48576.322.9277.0077.892.89
2214074-21407479.22880.84
3209183-20918377.41879.03
4208098-20809877.01678.57
5205768-20576876.15477.77
6196180-19618072.60574.15
20min1206477-20647776.41676.202.6978.7778.632.63
2212556-21255678.66681.16
3201596-20159674.61077.08
4212131-21213178.50980.92
5203436-20343675.29177.75
6199214-19921473.72876.08
30min1213704-21370479.09179.922.6582.2983.202.59
2225415-22541583.42586.79
3213978-21397879.19282.49
4208761-20876177.26180.55
5219248-21924881.14384.44
6214642-21464279.43882.61
45min1223282-22328282.63680.971.9086.7185.121.78
2214388-21438879.34483.63
3220037-22003781.43585.61
4214290-21429079.30883.45
5223456-22345682.70086.90
6217185-21718580.37984.43
60min1228096-22809684.41783.052.5289.4188.112.38
2228213-22821384.46189.63
3213718-21371879.09684.18
4222930-22293082.50587.53
5228111-22811184.42389.54
6225380-22538083.41288.36
极限1237947-23794788.06388.391.6394.0094.371.57
2244075-24407590.33196.44
3237541-23754187.91393.88
4232614-23261486.08992.03
5239625-23962588.68494.74
6241230-24123089.27895.15
瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101028-202405对照品来源中检所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)20供试品稀释倍数10系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.052519362519372530172530142533472526500.27
211.152513302517152515220.11
单位质量响应值RSD%判断
22864.2522558.030.96数据可信
供试品溶液-WK0055批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1158111-15811159.31465.4011.4859.3165.4011.48
2151435-15143556.80956.81
3199257-19925774.74974.75
4165239-16523961.98861.99
5196924-19692473.87473.87
6175040-17504065.66565.66
10min1197498-19749874.08977.968.1674.7578.688.18
2190070-19007071.30371.93
3218220-21822081.86382.69
4194517-19451772.97173.66
5234500-23450087.97088.79
6212019-21201979.53780.27
15min1209594-20959478.62779.347.2980.1180.947.31
2191540-19154071.85473.28
3216722-21672281.30183.04
4199074-19907474.68176.18
5235519-23551988.35390.15
6216563-21656381.24182.85
20min1223506-22350683.84677.7813.4286.2080.2613.16
2190980-19098071.64473.87
3221551-22155183.11385.76
4157618-15761859.12961.46
5221451-22145183.07585.86
6228986-22898685.90288.42
30min1240712-24071290.30182.208.0193.5985.547.91
2213036-21303679.91882.94
3215601-21560180.88184.45
4191416-19141671.80874.79
5235091-23509188.19291.90
6218824-21882482.09085.56
45min1240964-24096490.39583.577.2794.6987.827.02
2230590-23059086.50490.41
3201339-20133975.53080.00
4204397-20439776.67880.46
5233135-23313587.45892.14
6226235-22623584.87089.25
60min1228628-22862885.76878.3411.8791.0683.5211.18
2227375-22737585.29790.16
3163976-16397661.51466.82
4196897-19689773.86478.50
5220116-22011682.57488.23
6216056-21605681.05186.38
极限1263676-26367698.91591.006.10105.1697.055.85
2221314-22131483.02488.84
3233613-23361387.63893.63
4249221-24922193.49398.95
5249709-24970993.676100.25
6237935-23793589.25995.49
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