左氨氯地平叶酸片项目信息
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%
116.741824241823671822731824021822301823390.05
217.071892201892021892110.01
单位质量响应值RSD%判断
10892.4111084.421.24数据可信
供试品溶液-8153342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%
5min133509-3350930.80887.3931.8230.8187.3931.82
2110659-110659101.741101.74
3108004-10800499.30099.30
4106934-10693498.31698.32
5107689-10768999.01099.01
6103483-10348395.14395.14
10min160532-6053255.65492.2519.5156.0093.2219.63
2111016-111016102.069103.20
3107479-10747998.81799.92
4108093-10809399.382100.47
5108764-10876499.999101.10
6106126-10612697.57398.63
15min179167-7916772.78796.2412.3373.7598.2312.58
2108978-108978100.195102.46
3109837-109837100.985103.19
4107331-10733198.681100.88
5106864-10686498.252100.46
6115857-115857106.520108.66
20min194738-9473887.10396.054.7188.8799.125.19
2107834-10783499.144102.52
3107307-10730798.659101.98
4105654-10565497.139100.43
5106767-10676798.163101.47
6104538-10453896.11399.44
30min1111337-111337102.36497.422.84105.10101.562.18
2107176-10717698.539103.02
3105222-10522296.742101.16
4104358-10435895.948100.32
5105000-10500096.538100.93
6102689-10268994.41398.81
45min1124927-124927114.85998.988.00118.73104.196.99
2106141-10614197.587103.16
3104843-10484396.394101.89
4104487-10448796.066101.50
5104204-10420495.806101.27
6101328-10132893.16298.60
60min1129983-129983119.50898.5010.53124.66104.819.37
2104931-10493196.474103.13
3103170-10317094.855101.42
4101987-10198793.768100.27
5101137-10113792.98699.52
6101585-10158593.39899.88
90min1130983-130983120.42798.1811.19126.91105.599.98
2103859-10385995.489103.22
3102969-10296994.671102.29
4101721-10172193.523101.07
5101575-10157593.389100.95
699613-9961391.58599.10
极限1132059-132059121.41697.6911.95129.23106.1810.69
2102492-10249294.232103.02
3102164-10216493.930102.60
4101017-10101792.876101.46
5100273-10027392.192100.79
699490-9949091.472100.00
左氨氯地平叶酸片项目信息
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%
116.381999041998751997991997841996961998120.05
216.302010382011732011060.05
单位质量响应值RSD%判断
12198.5312337.790.81数据可信
供试品溶液-8153342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%
5min1-0.00017.2752.540.0017.2652.54
227495-2749522.99523.00
327204-2720422.75222.75
426786-2678622.40222.40
525294-2529421.15421.15
617085-1708514.28914.29
10min1-0.00027.4151.000.0027.6051.00
240146-4014633.57633.83
338907-3890732.53932.79
439710-3971033.21133.46
546215-4621538.65138.89
631631-3163126.45426.61
15min1-0.00033.9551.500.0034.4451.47
246891-4689139.21739.85
346023-4602338.49139.11
446857-4685739.18839.81
561190-6119051.17651.84
642566-4256635.60036.05
20min1-0.00037.9852.370.0038.8552.31
251339-5133942.93744.00
349751-4975141.60942.65
450096-5009641.89742.95
571256-7125659.59460.83
650023-5002341.83642.68
30min1-0.00043.2753.500.0044.5653.37
255940-5594046.78548.33
353518-5351844.75946.26
453826-5382645.01746.54
582915-8291569.34571.24
664194-6419453.68855.00
45min1-0.00048.0055.300.0049.7855.06
258903-5890349.26351.32
355896-5589646.74848.75
457135-5713547.78449.80
592391-9239177.27079.94
680025-8002566.92868.84
60min1-0.00050.4457.160.0052.7556.79
259784-5978450.00052.61
356762-5676247.47249.99
457550-5755048.13150.68
597721-9772181.72885.25
690049-9004975.31177.96
90min1-0.00053.1458.480.0056.0158.03
261490-6149051.42654.59
358417-5841748.85651.90
459404-5940449.68252.77
5103844-10384486.84991.28
698098-9809882.04385.53
极限1-0.00063.8250.770.0067.2850.84
284019-8401970.26874.00
382755-8275569.21172.80
483126-8312669.52173.16
5105156-10515687.94693.34
6102775-10277585.95590.36
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