阿齐沙坦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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.152976042973862979272975952972162975460.09
211.102968652966372967510.06
单位质量响应值RSD%判断
26685.7426734.320.13数据可信
供试品溶液-2024010921批-阿齐沙坦-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%
5min1123878-12387841.63740.1717.8741.6440.1717.86
280120-8012026.92926.93
3145352-14535248.85448.85
4119948-11994840.31640.32
5124637-12463741.89241.89
6123115-12311541.38041.38
10min1238005-23800579.99683.106.7280.2383.326.73
2226282-22628276.05676.21
3261531-26153187.90388.17
4256911-25691186.35086.57
5233985-23398578.64578.88
6266742-26674289.65589.88
15min1263288-26328888.49491.955.1489.1792.635.15
2254768-25476885.63086.20
3279669-27966994.00094.76
4290560-29056097.66098.36
5266990-26699089.73890.41
6286110-28611096.16496.89
20min1276337-27633792.88094.843.1294.0596.043.16
2267681-26768189.97091.02
3286037-28603796.14097.42
4288026-28802696.80898.05
5283188-28318895.18296.35
6291743-29174398.05899.32
30min1290297-29029797.57297.722.2099.2699.442.24
2278512-27851293.61195.16
3291753-29175398.06199.88
4292467-29246798.301100.09
5296290-29629099.586101.28
6295109-29510999.189101.00
45min1293290-29329098.57898.540.56100.80100.810.58
2291785-29178598.072100.14
3290792-29079297.738100.10
4293681-29368198.709101.04
5294926-29492699.128101.38
6294646-29464699.033101.39
60min1298629-298629100.37299.120.68103.15101.940.66
2293624-29362498.690101.30
3293806-29380698.751101.65
4293538-29353898.661101.54
5295698-29569899.387102.19
6294190-29419098.880101.79
极限1293264-29326498.56999.180.91101.90102.540.79
2300231-300231100.911104.07
3293225-29322598.556102.01
4293503-29350398.649102.08
5294879-29487999.112102.46
6295298-29529899.253102.71
阿齐沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.976588365730655166581365776657440.22
215.926459964758646780.18
单位质量响应值RSD%判断
4116.724062.690.94数据可信
供试品溶液-2024010921批-氨氯地平-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%
5min118008-1800828.54931.0512.2128.5531.0512.21
218571-1857129.44229.44
321529-2152934.13134.13
416787-1678726.61426.61
523246-2324636.85436.85
619367-1936730.70430.70
10min152960-5296083.96177.475.7584.1277.645.74
246001-4600172.92973.09
347837-4783775.83976.03
445819-4581972.64072.79
550076-5007679.38979.59
650495-5049580.05380.22
15min156191-5619189.08486.882.7089.7187.482.69
253697-5369785.13085.70
352499-5249983.23083.84
454654-5465486.64787.20
555652-5565288.22988.87
656099-5609988.93889.55
20min156863-5686390.14985.893.6591.2786.983.65
251449-5144981.56682.61
353779-5377985.26086.33
452609-5260983.40584.44
555533-5553388.04089.18
654834-5483486.93288.04
30min159056-5905693.62689.224.0995.2590.784.08
253450-5345084.73886.23
354995-5499587.18788.73
454401-5440186.24687.74
557468-5746891.10892.73
658307-5830792.43894.03
45min156996-5699690.36089.323.2392.5091.383.23
253960-5396085.54787.51
354703-5470386.72488.76
456029-5602988.82790.80
557481-5748191.12993.26
658866-5886693.32495.43
60min159748-5974894.72390.134.8997.3792.694.85
253547-5354784.89287.33
355102-5510287.35789.87
454496-5449686.39688.87
559556-5955694.41897.06
658676-5867693.02395.65
极限160335-6033595.65392.473.7598.8295.533.73
255498-5549887.98590.90
356145-5614589.01192.01
457878-5787891.75894.71
559424-5942494.20997.37
660694-6069496.22299.36
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