苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.018883489058889708910688815889570.15
214.058927889328893030.04
单位质量响应值RSD%判断
6349.546356.090.08数据可信
长期24月-供试品溶液-2022032901批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min139754-3975443.90643.2017.1343.9143.2017.13
225772-2577228.46428.46
344127-4412748.73648.74
440932-4093245.20745.21
541779-4177946.14246.14
642340-4234046.76246.76
10min153980-5398059.61859.352.0360.0659.782.04
253265-5326558.82859.11
354159-5415959.81560.30
455255-5525561.02661.48
553795-5379559.41359.87
651963-5196357.39057.86
15min158711-5871164.84363.772.9365.8864.802.89
257913-5791363.96164.83
357724-5772463.75364.84
459679-5967965.91266.97
557787-5778763.82264.88
654650-5465060.35861.40
20min162275-6227568.77966.843.2070.4668.503.12
261327-6132767.73269.24
360176-6017666.46168.18
462344-6234468.85570.58
559777-5977766.02067.71
657217-5721763.19364.84
30min164910-6491071.68968.803.3474.0671.133.28
262309-6230968.81771.01
361232-6123267.62770.01
464402-6440271.12873.54
561559-6155967.98870.34
659366-5936665.56667.84
45min168095-6809575.20773.812.2278.3076.832.17
268240-6824075.36778.25
367030-6703074.03177.09
467164-6716474.17977.30
566263-6626373.18476.22
664206-6420670.91273.84
60min168071-6807175.18072.693.7779.0276.453.64
267702-6770274.77378.40
366468-6646873.41077.21
467284-6728474.31178.17
562720-6272069.27173.04
662661-6266169.20572.85
极限168209-6820975.33375.363.0579.9379.842.93
269388-6938876.63581.01
371091-7109178.51683.05
468925-6892576.12480.73
565377-6537772.20576.66
666396-6639673.33077.66
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.018905589041892028908889012890800.09
214.058984989679897640.14
单位质量响应值RSD%判断
6358.326388.900.34数据可信
长期24月-供试品溶液-2022033001批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min146512-4651251.20245.7615.5551.2045.7615.55
244741-4474149.25349.25
337414-3741441.18741.19
448532-4853253.42653.43
541060-4106045.20145.20
631167-3116734.31034.31
10min158097-5809763.95664.103.3064.4764.563.36
258599-5859964.50865.00
356730-5673062.45162.86
461819-6181968.05368.59
557460-5746063.25463.71
656657-5665762.37062.71
15min162141-6214168.40870.223.5669.5671.323.58
264571-6457171.08372.22
363082-6308269.44370.48
467971-6797174.82576.04
561796-6179668.02869.11
663153-6315369.52270.49
20min164854-6485471.39473.574.3373.2375.374.31
266313-6631373.00074.85
365009-6500971.56573.30
472349-7234979.64581.61
564990-6499071.54473.31
667475-6747574.27975.94
30min167662-6766274.48577.813.5677.0380.353.52
270871-7087178.01880.60
370011-7001177.07179.52
474445-7444581.95284.71
568580-6858075.49677.98
672520-7252079.83382.24
45min171949-7194979.20579.783.8882.5083.103.80
271250-7125078.43581.79
368672-6867275.59778.81
475790-7579083.43387.01
571403-7140378.60481.84
675786-7578683.42986.63
60min172830-7283080.17480.552.5284.2684.662.55
275258-7525882.84786.99
372361-7236179.65883.63
475602-7560283.22687.64
571197-7119778.37782.40
671768-7176879.00583.04
极限172367-7236779.66581.401.2484.5586.321.28
273846-7384681.29386.26
373804-7380481.24786.02
475151-7515182.72987.98
574260-7426081.74986.55
674256-7425681.74486.57
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.018928689200892228894289129891560.15
214.058959189616896040.02
单位质量响应值RSD%判断
6363.746377.510.16数据可信
长期24月-供试品溶液-2022033101批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min144621-4462149.14448.464.4549.1448.464.44
242500-4250046.80846.81
346588-4658851.31051.31
441288-4128845.47345.47
545475-4547550.08450.08
643524-4352447.93547.94
10min152318-5231857.62160.974.5158.1161.464.48
255921-5592161.58962.06
358032-5803263.91464.43
453547-5354758.97459.43
553974-5397459.44459.95
658381-5838164.29864.78
15min156577-5657762.31165.322.8863.3866.422.88
259765-5976565.82266.91
360937-6093767.11368.27
458159-5815964.05465.10
559440-5944065.46466.56
660994-6099467.17668.30
20min159930-5993066.00468.665.3067.6970.415.20
266411-6641173.14274.88
364939-6493971.52173.34
460919-6091967.09368.78
557826-5782663.68765.44
664041-6404170.53272.33
30min162137-6213768.43570.171.9870.7972.611.93
262723-6272369.08071.55
364601-6460171.14973.69
465503-6550372.14274.50
563207-6320769.61372.00
664119-6411970.61873.12
45min162528-6252868.86574.955.4371.9078.095.32
269992-6999277.08680.25
372000-7200079.29782.55
467209-6720974.02177.10
565345-6534571.96875.05
671257-7125778.47981.68
60min166432-6643273.16574.763.4776.8978.653.37
268198-6819875.11079.05
368326-6832675.25179.29
470257-7025777.37881.20
564024-6402470.51374.32
670048-7004877.14881.14
极限168160-6816075.06878.464.8479.5283.094.71
275479-7547983.12987.82
375112-7511282.72587.52
468568-6856875.51880.11
568182-6818275.09379.60
671916-7191679.20583.97
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