苯磺酸氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.881003961010411004161012541013491008910.46
213.961011051006321008680.34
单位质量响应值RSD%判断
7268.807225.500.43数据可信
供试品溶液-8178316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%
5min133331-3333129.03927.417.0529.0427.417.06
232496-3249628.31128.31
331610-3161027.53927.54
429748-2974825.91725.92
533644-3364429.31129.31
627954-2795424.35424.35
10min162728-6272854.65051.624.3254.7051.664.31
260495-6049552.70452.75
357724-5772450.29050.34
456911-5691149.58249.63
561134-6113453.26153.31
656490-5649049.21549.26
15min168844-6884459.97861.092.8360.1261.232.83
270755-7075561.64361.78
372770-7277063.39963.53
467282-6728258.61758.74
571585-7158562.36662.50
669519-6951960.56660.69
20min176257-7625766.43765.723.0066.6865.963.00
273983-7398364.45564.69
378140-7814068.07768.31
472847-7284763.46663.69
577771-7777167.75668.00
673624-7362464.14364.37
30min179672-7967269.41270.482.2069.7670.822.20
280392-8039270.03970.38
383916-8391673.10973.46
478770-7877068.62668.96
581206-8120670.74871.10
681442-8144270.95471.28
45min187380-8738076.12777.382.0376.5977.842.01
287657-8765776.36876.83
389733-8973378.17778.65
491579-9157979.78580.23
589647-8964778.10278.57
686928-8692875.73376.18
极限1107107-10710793.31495.451.8793.9196.041.86
2106937-10693793.16593.75
3111222-11122296.89997.50
4109841-10984195.69696.27
5111511-11151197.15097.75
6110748-11074896.48697.06
苯磺酸氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.881005251020441008491009521007841010310.59
213.961009531005811007670.27
单位质量响应值RSD%判断
7278.897218.270.60数据可信
供试品溶液-8178316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%
5min131950-3195027.83027.368.7027.8327.368.70
226070-2607022.70822.71
331390-3139027.34227.34
432608-3260828.40328.40
532714-3271428.49628.50
633725-3372529.37629.38
10min163497-6349755.30955.342.7155.3655.382.71
261552-6155253.61553.65
366041-6604157.52557.57
464143-6414355.87255.92
564299-6429956.00856.06
661637-6163753.68953.74
15min174197-7419764.63065.071.2664.7765.211.26
273828-7382864.30864.44
376152-7615266.33366.47
475002-7500265.33165.47
573780-7378064.26664.41
675275-7527565.56965.71
20min178959-7895968.77869.261.9769.0269.501.97
279996-7999669.68169.92
381781-8178171.23671.49
476959-7695967.03567.28
579700-7970069.42369.67
679658-7965869.38669.63
30min185524-8552474.49674.740.6574.8675.100.64
286349-8634975.21575.57
386527-8652775.37075.74
485870-8587074.79775.16
585472-8547274.45174.81
685099-8509974.12674.49
45min188852-8885277.39578.683.1377.8879.173.11
293082-9308281.08081.56
391195-9119579.43679.93
491821-9182179.98180.47
585300-8530074.30174.79
691718-9171879.89180.38
极限1110935-11093596.63094.331.7897.2494.951.76
2108245-10824594.28794.90
3109493-10949395.37496.00
4106433-10643392.70993.33
5108879-10887994.84095.45
6105808-10580892.16592.78
苯磺酸氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.881005291007411005031001791012441006390.40
213.96997301005561001430.59
单位质量响应值RSD%判断
7250.657173.570.76数据可信
供试品溶液-8178316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%
5min135611-3561131.17630.374.7031.1830.374.70
232123-3212328.12328.12
334997-3499730.63930.64
434480-3448030.18630.19
536963-3696332.36032.36
633970-3397029.74029.74
10min159186-5918651.81649.583.1951.8749.643.19
257311-5731150.17450.22
353795-5379547.09647.15
455632-5563248.70448.75
557013-5701349.91349.97
656892-5689249.80749.86
15min171033-7103362.18758.613.7362.3358.743.73
265664-6566457.48757.62
363893-6389355.93656.07
466996-6699658.65358.78
565739-6573957.55257.69
668351-6835159.83959.97
20min178476-7847668.70364.224.6268.9564.454.62
267983-6798359.51759.74
372234-7223463.23963.46
473656-7365664.48464.71
574346-7434665.08865.32
673417-7341764.27464.51
30min186514-8651475.74071.443.5976.1071.783.59
278354-7835468.59768.92
380134-8013470.15570.48
482790-8279072.48072.82
579546-7954669.64069.98
682251-8225172.00872.35
45min193838-9383882.15278.482.6182.6378.942.61
287469-8746976.57677.02
387722-8772276.79877.24
490420-9042079.16079.62
588821-8882177.76078.22
689618-8961878.45878.92
极限1116997-116997102.42797.982.44103.0598.572.45
2111666-11166697.76098.33
3110050-11005096.34596.92
4112065-11206598.10998.70
5109125-10912595.53696.12
6111602-11160297.70498.29
苯磺酸氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.881013721008811007221006661007851008850.29
213.961008061012741010400.33
单位质量响应值RSD%判断
7268.377237.820.30数据可信
供试品溶液-8178316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%
5min134695-3469530.20230.436.3430.2030.436.35
235745-3574531.11631.12
335346-3534630.76930.77
432209-3220928.03828.04
538563-3856333.56933.57
633182-3318228.88528.88
10min159536-5953651.82649.994.9351.8850.044.93
256356-5635649.05849.11
357693-5769350.22250.27
452278-5227845.50845.55
559736-5973652.00052.06
658983-5898351.34551.39
15min168903-6890359.98058.744.8060.1258.884.80
267039-6703958.35758.49
365465-6546556.98757.12
462570-6257054.46754.59
571905-7190562.59362.74
669023-6902360.08560.22
20min176642-7664266.71764.634.1266.9564.864.11
273299-7329963.80764.04
375160-7516065.42765.66
469355-6935560.37460.59
577962-7796267.86668.11
673072-7307263.60963.84
30min183610-8361072.78372.082.7973.1372.422.79
282090-8209071.45971.80
384274-8427473.36173.70
478738-7873868.54168.86
585390-8539074.33274.69
682723-8272372.01072.35
45min189113-8911377.57377.942.4578.0478.402.46
287959-8795976.56877.02
390495-9049578.77679.24
486265-8626575.09475.52
592082-9208280.15780.64
691323-9132379.49779.96
极限1109112-10911294.98297.152.4495.5897.742.43
2111389-11138996.96497.55
3109850-10985095.62496.22
4109472-10947295.29595.85
5114078-11407899.30599.92
6115707-115707100.723101.32
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