叶酸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%
115.777371473884736917357473657737040.16
215.857403874246741420.20
单位质量响应值RSD%判断
4673.684677.730.07数据可信
供试品溶液-2024092121批-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%
5min138866-3886683.97280.895.4483.9780.895.44
235622-3562276.96376.96
334436-3443674.40174.40
439834-3983486.06386.06
537662-3766281.37081.37
638211-3821182.55782.56
10min138034-3803482.17485.543.2983.1186.443.28
238271-3827182.68683.54
339026-3902684.31785.14
440647-4064787.82088.78
540849-4084988.25689.16
640728-4072887.99588.91
15min140427-4042787.34485.553.2489.1987.403.21
238815-3881583.86285.64
338316-3831682.78384.55
440064-4006486.56088.49
541519-4151989.70491.59
638429-3842983.02884.92
20min136993-3699379.92584.772.9582.7487.572.88
239146-3914684.57787.28
339428-3942885.18687.87
440135-4013586.71389.61
539975-3997586.36889.25
639736-3973685.85188.67
30min137699-3769981.45079.753.1785.1683.493.04
234821-3482175.23278.88
337747-3774781.55485.18
436918-3691879.76383.62
536419-3641978.68582.53
637856-3785681.79085.56
45min136498-3649878.85679.284.7783.4783.904.51
234555-3455574.65879.14
339510-3951085.36389.90
435897-3589777.55782.30
537856-3785681.79086.50
635837-3583777.42782.11
60min135119-3511975.87678.984.1181.3684.493.95
234738-3473875.05380.36
337114-3711480.18685.67
436787-3678779.48085.09
538903-3890384.05289.68
636677-3667779.24284.78
90min139244-3924484.78879.813.1191.1286.202.86
236359-3635978.55584.70
336227-3622778.27084.65
436721-3672179.33785.83
536364-3636478.56685.12
636727-3672779.35085.77
极限133181-3318171.68976.944.4378.9684.214.13
234757-3475775.09482.11
336170-3617078.14785.39
435361-3536176.39983.77
537800-3780081.66989.10
636388-3638878.61885.92
叶酸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%
115.589347993263934149356393571934580.14
215.529326793481933740.17
单位质量响应值RSD%判断
5998.596016.370.21数据可信
供试品溶液-2024092121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%
5min110026-1002617.12320.007.8017.1220.007.80
212195-1219520.82820.83
312731-1273121.74321.74
411716-1171620.00920.01
511936-1193620.38520.39
611670-1167019.93119.93
10min118679-1867931.90136.216.8132.0936.446.81
221649-2164936.97437.21
322952-2295239.19939.44
421311-2131136.39736.62
521918-2191837.43337.66
620709-2070935.36835.59
15min124757-2475742.28246.956.0842.8347.576.09
228012-2801247.84148.48
329690-2969050.70751.38
427300-2730046.62547.25
528395-2839548.49549.14
626773-2677345.72546.34
20min128609-2860948.86152.955.4549.8854.105.47
231676-3167654.09955.27
333180-3318056.66757.91
430847-3084752.68353.83
532139-3213954.88956.07
629584-2958450.52651.65
30min133203-3320356.70759.634.7058.2661.374.73
235308-3530860.30262.08
337545-3754564.12265.99
434252-3425258.49860.23
535778-3577861.10462.90
633410-3341057.06058.74
45min136358-3635862.09564.543.9464.2866.943.98
238641-3864165.99468.44
339494-3949467.45170.03
436461-3646162.27164.65
539235-3923567.00869.48
636561-3656162.44264.76
60min138463-3846365.69067.553.5468.5770.663.57
240522-4052269.20772.38
340928-4092869.90073.23
439406-3940667.30170.37
540587-4058769.31872.53
637397-3739763.86966.88
90min141199-4119970.36371.243.5973.9775.113.57
242968-4296873.38477.33
342602-4260272.75976.87
442346-4234672.32276.14
542262-4226272.17876.16
638914-3891466.46070.18
极限142227-4222772.11872.613.1676.5177.273.16
243654-4365474.55679.32
343175-4317573.73878.65
442840-4284073.16577.79
543248-4324873.86278.65
639958-3995868.24372.70
叶酸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%
115.777307573060732077317173018731060.11
215.857320873344732760.14
单位质量响应值RSD%判断
4635.764623.090.20数据可信
供试品溶液-2024092121批-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%
5min138055-3805583.04280.972.5883.0480.972.58
236440-3644079.51779.52
336671-3667180.02280.02
436989-3698980.71580.72
538465-3846583.93683.94
636021-3602178.60378.60
10min140034-4003487.36087.232.0288.2888.121.99
239140-3914085.40986.29
339805-3980586.86087.75
439301-3930185.76186.66
540158-4015887.63188.56
641395-4139590.33091.20
15min141421-4142190.38787.942.5492.2889.812.51
239887-3988787.03988.87
339488-3948886.16988.02
439076-3907685.27087.12
540357-4035788.06589.97
641578-4157890.72992.61
20min140477-4047788.32786.592.4291.2289.442.37
239843-3984386.94389.74
339820-3982086.89389.70
438488-3848883.98686.78
538615-3861584.26487.15
640847-4084789.13492.02
30min136191-3619178.97482.792.9882.8586.602.84
238336-3833683.65587.42
338393-3839383.77987.56
437558-3755881.95785.69
537594-3759482.03685.86
639573-3957386.35490.23
45min137696-3769682.25880.632.9087.0185.362.75
235494-3549477.45382.15
338352-3835283.69088.40
437157-3715781.08285.72
535939-3593978.42483.16
637069-3706980.89085.73
60min137549-3754981.93781.663.6187.6187.283.42
236200-3620078.99484.55
337709-3770982.28787.92
435658-3565877.81183.35
539450-3945086.08691.69
637963-3796382.84188.57
90min137268-3726881.32477.365.1487.9183.894.79
235376-3537677.19683.63
337453-3745381.72888.28
433499-3349973.10079.51
533170-3317072.38278.94
635934-3593478.41385.07
极限134842-3484276.03076.515.6883.5183.905.27
233533-3353373.17480.47
336031-3603178.62586.09
432131-3213170.11577.33
537607-3760782.06489.43
636239-3623979.07986.60
叶酸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%
115.589296193110931479282192605929290.24
215.529222892211922200.02
单位质量响应值RSD%判断
5964.635942.010.27数据可信
供试品溶液-2024092121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%
5min110919-1091918.81820.054.2218.8220.054.22
212122-1212220.89120.89
311505-1150519.82819.83
411552-1155219.90919.91
511438-1143819.71219.71
612259-1225921.12721.13
10min120814-2081435.87136.502.1536.0836.722.16
221689-2168937.37937.61
321243-2124336.61036.83
420961-2096136.12436.35
520635-2063535.56335.78
621721-2172137.43437.67
15min127287-2728747.02747.081.8447.6347.701.84
227307-2730747.06147.71
327363-2736347.15847.78
426747-2674746.09646.72
526974-2697446.48747.10
628217-2821748.63049.28
20min131333-3133354.00053.201.6955.1354.351.68
231226-3122653.81554.99
330835-3083553.14154.29
430421-3042152.42853.56
530084-3008451.84752.98
631302-3130253.94655.14
30min134884-3488460.12060.050.9761.8561.790.96
235385-3538560.98362.75
334578-3457859.59261.33
435021-3502160.35662.07
534445-3444559.36361.07
634755-3475559.89761.69
45min139200-3920067.55865.691.8869.9668.101.81
237686-3768664.94967.39
337314-3731464.30766.71
438760-3876066.80069.19
537782-3778265.11467.48
637957-3795765.41667.87
60min141624-4162471.73568.582.8874.8871.722.76
238801-3880166.87070.04
338798-3879866.86569.98
440548-4054869.88173.01
539015-3901567.23970.33
639982-3998268.90672.09
90min145000-4500077.55471.624.8781.5075.524.65
240500-4050069.79873.71
339664-3966468.35772.22
442925-4292573.97877.88
540258-4025869.38173.22
641009-4100970.67574.62
极限145071-4507177.67672.254.1382.4876.953.96
240708-4070870.15774.84
340881-4088170.45575.08
442570-4257073.36678.09
540490-4049069.78174.39
641824-4182472.08076.81
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