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)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%
118.192036722033762033272036992036062035360.09
218.382037152040252038700.11
单位质量响应值RSD%判断
11189.4411091.950.62数据可信
供试品溶液-20231106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%
5min1183231-18323183.07686.219.7183.0886.219.71
2184694-18469483.73983.74
3218384-21838499.01499.01
4169729-16972976.95476.95
5178280-17828080.83180.83
6206542-20654293.64593.65
10min1216093-21609397.97596.701.4798.9097.661.51
2208350-20835094.46595.40
3216456-21645698.14099.24
4211010-21101095.67196.53
5213398-21339896.75497.65
6214430-21443097.22198.26
15min1214397-21439797.20696.602.1299.2298.642.11
2204014-20401492.49994.48
3216181-21618198.015100.21
4214952-21495297.45899.38
5213863-21386396.96498.94
6214977-21497797.46999.59
20min1212367-21236796.28695.431.8099.3898.541.79
2202831-20283191.96394.97
3211792-21179296.02599.31
4212003-21200396.12199.12
5212518-21251896.35599.41
6211420-21142095.85799.06
30min1211144-21114495.73294.581.8899.8998.741.86
2201003-20100391.13495.16
3210595-21059595.48399.83
4211419-21141995.85699.93
5208709-20870994.62898.75
6208733-20873394.63898.91
45min1207345-20734594.00993.341.7799.2398.551.73
2199035-19903590.24195.28
3205583-20558393.21098.62
4209776-20977695.111100.25
5206789-20678993.75798.93
6206636-20663693.68899.01
60min1204748-20474892.83292.321.5099.1098.581.50
2197855-19785589.70695.75
3205647-20564793.23999.68
4205741-20574193.28299.47
5205172-20517293.02499.24
6202576-20257691.84798.21
90min1203157-20315792.11091.691.5199.4198.971.52
2196122-19612288.92195.96
3203464-20346492.25099.73
4204594-20459492.76299.99
5203241-20324192.14899.40
6202775-20277591.93799.32
极限1201680-20168091.44190.821.6599.7799.121.63
2193870-19387087.90095.93
3201611-20161191.40999.91
4202952-20295292.017100.28
5201711-20171191.45599.73
6200066-20006690.70999.11
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%
115.721900591901401899431902591902901901380.08
215.741900741900321900530.02
单位质量响应值RSD%判断
12095.2912074.520.13数据可信
供试品溶液-20231106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%
5min116013-1601313.59516.4835.1913.5916.4835.19
220484-2048417.39117.39
329802-2980225.30225.30
412402-1240210.52910.53
513280-1328011.27511.27
624492-2449220.79420.79
10min141531-4153135.26035.4219.6635.4135.6019.74
241245-4124535.01735.21
353941-5394145.79646.08
432697-3269727.76027.88
533305-3330528.27628.40
647580-4758040.39540.63
15min156906-5690648.31348.4311.8348.8649.0111.97
255453-5545347.07947.66
367001-6700156.88357.67
451442-5144243.67444.10
548988-4898841.59042.03
662494-6249453.05753.74
20min166348-6634856.32956.847.2957.4157.967.50
266507-6650756.46457.57
374373-7437363.14264.56
463058-6305853.53654.45
560966-6096651.76052.66
670482-7048259.83961.11
30min178060-7806066.27266.573.8867.9868.314.12
277082-7708265.44267.17
383130-8313070.57772.70
477459-7745965.76267.27
574288-7428863.07064.55
680420-8042068.27670.21
45min186187-8618773.17273.122.1575.6175.602.40
285647-8564772.71475.17
388322-8832274.98577.89
486019-8601973.03075.27
582987-8298770.45572.63
687564-8756474.34177.03
60min189738-8973876.18776.551.5979.4479.851.75
290068-9006876.46779.73
392874-9287478.84982.59
490103-9010376.49779.54
589589-8958976.06079.02
688627-8862775.24478.76
90min192456-9245678.49580.421.3782.6084.561.50
294388-9438880.13584.25
396400-9640081.84386.46
494911-9491180.57984.48
594892-9489280.56384.37
695265-9526580.87985.23
极限195708-9570881.25581.760.4386.2386.800.60
295972-9597281.48086.49
396698-9669882.09687.62
496220-9622081.69086.48
596711-9671182.10786.81
696525-9652581.94987.20
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