厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
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%
113.663371233418334273345933414334860.39
213.723332833267332980.13
单位质量响应值RSD%判断
2451.392426.970.71数据可信
供试品溶液-8145761批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133952-3395243.94345.546.0943.9445.546.09
232710-3271042.33642.34
337992-3799249.17249.17
437489-3748948.52148.52
533741-3374143.67043.67
635219-3521945.58345.58
10min142199-4219954.61756.264.4854.8656.524.49
241704-4170453.97754.21
345899-4589959.40659.68
445770-4577059.23959.51
541733-4173354.01454.26
643513-4351356.31856.57
15min146295-4629559.91961.014.5660.4761.574.54
246946-4694660.76161.30
351109-5110966.14966.75
445315-4531558.65059.25
545442-4544258.81559.36
647706-4770661.74562.31
20min149236-4923663.72565.764.4464.6166.674.43
249366-4936663.89364.77
355096-5509671.31072.28
450408-5040865.24266.17
549404-4940463.94364.81
651343-5134366.45267.36
30min153328-5332869.02172.753.9570.2674.023.95
255529-5552971.87073.10
359545-5954577.06878.43
457854-5785474.87976.17
554797-5479770.92372.15
656181-5618172.71473.99
45min156603-5660373.26075.662.6974.8877.332.71
258207-5820775.33676.96
360880-6088078.79680.59
459646-5964677.19978.90
557280-5728074.13675.75
658114-5811475.21676.90
60min158316-5831675.47777.413.9977.5079.503.94
259971-5997177.61979.66
362949-6294981.47483.71
461426-6142679.50281.63
560082-6008277.76379.79
656122-5612272.63874.74
90min163179-6317981.77183.571.6184.2286.101.66
264277-6427783.19285.67
366347-6634785.87188.56
464863-6486383.95186.52
564260-6426083.17085.63
664490-6449083.46885.97
120min166576-6657686.16888.812.0989.0791.802.06
270877-7087791.73594.67
368942-6894289.23092.39
469148-6914889.49792.54
568111-6811188.15591.08
668030-6803088.05091.02
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限176568-7656899.10098.371.07102.48101.850.98
275218-7521897.353100.80
375620-7562097.873101.53
475075-7507597.168100.71
577039-7703999.710103.12
676492-7649299.002102.46
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
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%
113.663275332506324833263732540325840.35
213.723302132872329460.32
单位质量响应值RSD%判断
2385.362401.310.48数据可信
供试品溶液-8145761批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134705-3470545.77848.713.9745.7848.713.96
235506-3550646.83446.83
337711-3771149.74349.74
438213-3821350.40550.40
537364-3736449.28549.29
638060-3806050.20350.20
10min143497-4349757.37560.033.0557.6360.303.05
244287-4428758.41758.68
346679-4667961.57261.85
446256-4625661.01461.29
545376-4537659.85360.13
646967-4696761.95262.23
15min147313-4731362.40866.564.4962.9867.174.48
248187-4818763.56164.15
350621-5062166.77267.39
452642-5264269.43870.06
551292-5129267.65768.26
652716-5271669.53570.16
20min150358-5035866.42569.873.3867.3470.853.39
251233-5123367.57968.52
353711-5371170.84871.84
454643-5464372.07773.08
553268-5326870.26371.25
654616-5461672.04173.05
30min155606-5560673.34775.272.0874.6476.632.07
257424-5742475.74577.06
357499-5749975.84477.23
458992-5899277.81479.22
556485-5648574.50775.88
656356-5635674.33675.75
45min156974-5697475.15278.693.6576.8580.463.63
257440-5744075.76677.50
361393-6139380.98182.78
462063-6206381.86483.70
558925-5892577.72579.51
661123-6112380.62482.45
60min159531-5953178.52482.483.0480.6484.703.04
261439-6143981.04183.20
364797-6479785.47187.72
464046-6404684.48086.77
562247-6224782.10784.33
663106-6310683.24085.51
90min162637-6263782.62184.551.9885.1787.222.01
262478-6247882.41285.02
364804-6480485.48088.21
465597-6559786.52689.29
564297-6429784.81187.49
664764-6476485.42788.16
120min163280-6328083.47086.962.5386.4890.102.54
264929-6492985.64588.71
366056-6605687.13190.34
468174-6817489.92593.17
566467-6646787.67390.82
666635-6663587.89591.10
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限171023-7102393.68395.431.4697.1699.061.50
271217-7121793.93997.48
372620-7262095.79099.48
473767-7376797.303101.04
572983-7298396.26899.90
672492-7249295.62199.32
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