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)5
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1250
标示量(mg)80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%
111.868169258147608159858157888147428156400.12
211.658154548131968143250.20
单位质量响应值RSD%判断
68772.3469899.141.15数据可信
供试品溶液-F73103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%
5min199909-9990912.96913.163.5012.9713.163.49
298494-9849412.78612.79
3107108-10710813.90413.90
498571-9857112.79612.80
599685-9968512.94012.94
6104348-10434813.54613.55
10min1199590-19959025.90925.462.9625.9825.532.97
2196167-19616725.46525.54
3204299-20429926.52026.60
4192299-19229924.96325.03
5187502-18750224.34024.41
6196897-19689725.56025.63
15min1279393-27939336.26836.182.3136.4836.402.31
2282436-28243636.66436.88
3289027-28902737.51937.74
4276655-27665535.91336.12
5271168-27116835.20135.41
6273686-27368635.52835.74
20min1356399-35639946.26544.782.2246.6845.202.21
2337726-33772643.84144.26
3350522-35052245.50245.93
4339922-33992244.12644.54
5338063-33806343.88544.29
6347223-34722345.07445.49
30min1464943-46494360.35560.521.3961.0361.181.39
2471553-47155361.21361.87
3471911-47191161.26061.95
4458483-45848359.51660.17
5458679-45867959.54260.19
6471646-47164661.22561.89
45min1586801-58680176.17476.031.1777.1877.031.17
2591777-59177776.82077.82
3593047-59304776.98478.01
4573933-57393374.50375.49
5584236-58423675.84176.82
6584388-58438875.86076.87
60min1640496-64049683.14483.770.7084.5885.200.69
2653087-65308784.77886.20
3647547-64754784.05985.51
4644223-64422383.62885.03
5642047-64204783.34584.74
6644713-64471383.69185.12
极限1702326-70232691.17090.760.5293.0792.650.49
2699086-69908690.75092.65
3692320-69232089.87191.79
4700158-70015890.88992.75
5701803-70180391.10292.96
6699226-69922690.76892.66
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)5
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1250
标示量(mg)80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%
111.868165768168668154968149978148808157630.12
211.658121118140958131030.18
单位质量响应值RSD%判断
68782.7269794.251.04数据可信
供试品溶液-F73103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%
5min1161019-16101920.91621.736.7820.9221.736.78
2169876-16987622.06722.07
3158085-15808520.53520.54
4161450-16145020.97220.97
5188893-18889324.53724.54
6164197-16419721.32921.33
10min1322926-32292641.94841.778.9042.0641.898.90
2314666-31466640.87541.00
3302620-30262039.31039.42
4320791-32079141.67041.79
5375154-37515448.73248.87
6293066-29306638.06938.19
15min1454452-45445259.03358.369.7559.3858.719.74
2445107-44510757.81958.17
3426003-42600355.33755.67
4439304-43930457.06557.41
5530053-53005368.85369.26
6400601-40060152.03852.37
20min1564758-56475873.36173.597.5074.0474.277.51
2572966-57296674.42875.10
3535541-53554169.56670.21
4550209-55020971.47172.14
5646328-64632883.95784.75
6529459-52945968.77669.40
30min1708063-70806391.97693.071.7893.0694.151.83
2727921-72792194.55695.64
3717690-71769093.22794.25
4711072-71107292.36793.43
5733906-73390695.33396.59
6700081-70008190.94091.94
45min1720705-72070593.61994.251.7095.2195.851.69
2745317-74531796.81698.43
3735395-73539595.52797.07
4714319-71431992.78994.36
5722921-72292193.90695.69
6714817-71481792.85494.36
60min1697893-69789390.65591.241.4592.7793.371.44
2719378-71937893.44695.59
3695119-69511990.29592.37
4709843-70984392.20894.30
5699273-69927390.83593.14
6693083-69308390.03192.05
极限1704417-70441791.50390.383.5094.1293.013.47
2720025-72002593.53096.20
3701829-70182991.16793.74
4694120-69412090.16592.77
5705010-70501091.58094.39
6649204-64920484.33186.85
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