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)10供试品稀释倍数5系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.052508422510502510772504872505402507990.12
211.152534932531502533220.10
单位质量响应值RSD%判断
22696.7422719.460.08数据可信
供试品溶液-506376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%
5min1201282-20128275.51677.995.5875.5277.995.57
2201527-20152775.60875.61
3212575-21257579.75279.75
4193932-19393272.75872.76
5211089-21108979.19579.19
6226858-22685885.11185.11
10min1229620-22962086.14787.317.0186.9988.186.99
2228996-22899685.91386.75
3230828-23082886.60187.49
4210668-21066879.03779.85
5235004-23500488.16789.05
6261168-26116897.98398.93
15min1244661-24466191.79090.904.4293.5992.744.43
2232885-23288587.37289.17
3235197-23519788.24090.09
4236675-23667588.79490.48
5242116-24211690.83592.70
6262196-26219698.369100.40
20min1249516-24951693.61291.344.2796.4394.184.28
2234751-23475188.07290.84
3235405-23540588.31891.15
4237093-23709388.95191.62
5242590-24259091.01393.88
6261374-26137498.061101.19
30min1255889-25588996.00392.554.5699.8696.414.54
2238213-23821389.37193.12
3233951-23395187.77291.58
4242070-24207090.81894.48
5246232-24623292.38096.26
6263777-26377798.962103.18
45min1264698-26469899.30894.613.69104.2399.503.63
2246920-24692092.63897.37
3240867-24086790.36795.15
4254884-25488495.626100.30
5245360-24536092.05396.96
6260326-26032697.667102.98
60min1266075-26607599.82493.934.50105.8599.874.44
2238667-23866789.54195.31
3240217-24021790.12395.91
4245043-24504391.93497.67
5250869-25086994.119100.05
6261277-26127798.024104.43
极限1273435-273435102.58697.283.44109.72104.273.36
2248925-24892593.390100.15
3252020-25202094.551101.34
4263058-26305898.692105.45
5255860-25586095.992102.97
6262498-26249898.482105.97
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)10供试品稀释倍数5系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.052514442508702503322504912510172508310.18
211.152508112502782505440.16
单位质量响应值RSD%判断
22699.6422470.310.72数据可信
供试品溶液-506376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%
5min1210685-21068579.47678.826.9279.4878.826.92
2209629-20962979.07879.08
3224471-22447184.67784.68
4206508-20650877.90177.90
5219488-21948882.79782.80
6182826-18282668.96768.97
10min1246693-24669393.06089.486.0093.9490.356.00
2223375-22337584.26385.14
3254971-25497196.18297.12
4232638-23263887.75888.62
5246084-24608492.83093.75
6219445-21944582.78183.55
15min1244932-24493292.39590.444.4494.3192.314.44
2221803-22180383.67085.49
3252024-25202495.07197.08
4242930-24293091.64093.48
5243525-24352591.86593.82
6233291-23329188.00489.69
20min1245605-24560592.64990.223.9995.5993.104.01
2223917-22391784.46887.21
3250532-25053294.50897.57
4238715-23871590.05092.91
5243098-24309891.70394.68
6233169-23316987.95890.62
30min1245989-24598992.79489.893.8896.7793.773.88
2222194-22219483.81887.50
3248112-24811293.59597.71
4237745-23774589.68493.54
5240081-24008190.56594.56
6235604-23560488.87692.52
45min1241868-24186891.23988.612.6596.2493.482.67
2223790-22379084.42089.03
3234378-23437888.41493.57
4235957-23595789.01093.87
5239267-23926790.25895.26
6234061-23406188.29492.92
60min1241813-24181391.21989.742.9997.2495.603.05
2226021-22602185.26290.81
3244514-24451492.23898.38
4238549-23854989.98795.83
5243291-24329191.77697.78
6233187-23318787.96593.57
极限1254861-25486196.14193.143.46103.17100.003.41
2231622-23162287.37493.87
3248831-24883193.866101.03
4254619-25461996.049102.89
5246414-24641492.95499.97
6245113-24511392.46499.05
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