替米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)0
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.033849683863853844923861803860183856090.22
210.993884323892323888320.15
单位质量响应值RSD%判断
34960.0235380.530.85数据可信
供试品溶液-F11946批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157252-5725214.65116.2913.0114.6516.2813.00
271152-7115218.20818.21
361199-6119915.66115.66
457468-5746814.70614.71
558070-5807014.86114.86
676685-7668519.62419.62
10min1108236-10823627.69829.8011.0227.7829.8911.03
2134524-13452434.42634.53
3117763-11776330.13630.22
4107491-10749127.50827.59
5102206-10220626.15526.24
6128446-12844632.87032.98
15min1149076-14907638.15043.628.8138.3843.888.82
2184278-18427847.15847.45
3177580-17758045.44445.70
4163323-16332341.79642.03
5161050-16105041.21441.44
6187446-18744647.96948.26
20min1199817-19981751.13555.257.2151.5855.747.24
2227768-22776858.28758.84
3221720-22172056.74057.25
4203955-20395552.19452.66
5203966-20396652.19652.65
6238085-23808560.92861.49
30min1266977-26697768.32169.674.0969.0570.484.08
2259983-25998366.53167.41
3289925-28992574.19475.02
4269639-26963969.00369.76
5265825-26582568.02668.77
6281232-28123271.96972.87
45min1302790-30279077.48679.501.9378.6080.691.94
2315631-31563180.77282.02
3305101-30510178.07879.31
4317658-31765881.29182.43
5308952-30895279.06380.19
6313779-31377980.29881.59
60min1348771-34877189.25388.712.6890.7990.352.64
2346994-34699488.79890.49
3334177-33417785.51887.19
4358431-35843191.72593.32
5337770-33777086.43888.00
6353812-35381290.54392.29
90min1371034-37103494.95093.324.3496.9995.454.18
2336448-33644886.09988.29
3367207-36720793.97196.11
4378755-37875596.92699.03
5377058-37705896.49298.54
6357471-35747191.47993.72
120min1374317-37431795.79094.182.7198.3696.822.60
2350838-35083889.78292.45
3376078-37607896.24198.91
4365726-36572693.59296.23
5376701-37670196.40098.98
6364369-36436993.24596.00
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1354018-35401890.59693.753.9193.6996.923.81
2344660-34466088.20191.37
3383008-38300898.014101.21
4369097-36909794.45597.61
5371768-37176895.13898.25
6375608-37560896.12199.39
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