叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.151946841946521942461942511942691944200.12
217.311943331941991942660.05
单位质量响应值RSD%判断
11336.4411222.760.72数据可信
供试品溶液-24050801批-左氨氯地平-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1112248-112248100.53299.691.02100.5399.681.01
2112403-112403100.671100.67
3111264-11126499.65199.65
4111981-111981100.293100.29
5110249-11024998.74298.74
6109672-10967298.22598.23
10min1110986-11098699.40299.010.61100.52100.120.61
2110318-11031898.80499.92
3111249-11124999.638100.74
4111048-11104899.458100.57
5109487-10948798.06099.16
6110216-11021698.71399.80
15min1109783-10978398.32597.430.81100.5599.640.80
2108920-10892097.55299.77
3108415-10841597.10099.31
4108830-10883097.47199.69
5107295-10729596.09698.28
6109458-10945898.034100.22
20min1108611-10861197.27596.900.47100.59100.190.46
2107300-10730096.10199.40
3108663-10866397.322100.61
4108079-10807996.799100.10
5108431-10843197.114100.37
6108048-10804896.771100.05
30min1104919-10491993.96895.461.0098.3699.830.95
2107591-10759196.362100.73
3107335-10733596.132100.51
4107470-10747096.253100.63
5106113-10611395.03899.37
6106089-10608995.01699.37
45min1105558-10555894.54194.780.5899.98100.210.57
2106706-10670695.569101.01
3106467-10646795.355100.80
4105625-10562594.601100.05
5105240-10524094.25699.65
6105338-10533894.34499.75
60min1104867-10486793.92293.910.24100.41100.390.22
2104620-10462093.701100.20
3104742-10474293.810100.31
4104970-10497094.014100.51
5104662-10466293.738100.17
6105272-10527294.285100.74
90min1103279-10327992.50092.970.47100.03100.490.44
2103485-10348592.684100.23
3103785-10378592.953100.50
4104659-10465993.736101.28
5103660-10366092.841100.32
6103941-10394193.093100.60
极限1103179-10317992.41092.390.47100.97100.950.45
2103230-10323092.456101.03
3104061-10406193.200101.78
4102929-10292992.186100.77
5102868-10286892.131100.64
6102703-10270391.984100.52
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.741902791903561902581905381904811903820.07
215.781895591895521895560.01
单位质量响应值RSD%判断
12095.4312012.420.49数据可信
供试品溶液-24050801批-叶酸-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min127080-2708023.05023.253.7123.0523.263.71
228509-2850924.26624.27
327674-2767423.55623.56
428198-2819824.00224.00
525796-2579621.95721.96
626663-2666322.69522.70
10min146292-4629239.40340.023.3139.6640.283.31
248757-4875741.50141.77
348325-4832541.13441.40
447805-4780540.69140.96
544649-4464938.00538.25
646271-4627139.38539.64
15min157725-5772549.13549.673.0149.8350.383.01
260014-6001451.08351.81
359347-5934750.51551.23
459359-5935950.52651.24
555167-5516746.95747.62
658539-5853949.82850.52
20min164772-6477255.13355.892.1156.3757.142.13
266703-6670356.77758.07
366867-6686756.91658.20
466689-6668956.76558.04
563387-6338753.95455.14
665547-6554755.79357.04
30min171282-7128260.67462.932.2462.5364.812.23
275857-7585764.56866.50
374140-7414063.10765.02
475359-7535964.14466.06
573011-7301162.14663.93
673937-7393762.93464.80
45min178836-7883667.10468.212.7569.6370.792.74
282566-8256670.27972.93
381297-8129769.19971.81
481753-8175369.58772.21
576611-7661165.21067.69
679763-7976367.89370.46
60min182016-8201669.81171.592.6573.0874.932.64
286070-8607073.26276.69
386133-8613373.31576.70
485518-8551872.79276.19
580884-8088468.84772.05
684050-8405071.54274.86
90min185863-8586373.08575.383.1077.1379.513.07
290339-9033976.89581.14
391703-9170378.05682.25
489931-8993176.54880.75
584640-8464072.04476.01
688910-8891075.67979.79
极限188668-8866875.47377.723.0880.3382.693.04
294319-9431980.28385.38
394631-9463180.54985.61
491492-9149277.87782.93
587825-8782574.75579.52
690940-9094077.40782.36
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