盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品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2000
标示量(mg)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992104432101492103432103512103242103220.06
216.002112312116112114210.13
单位质量响应值RSD%判断
13153.3513213.810.33数据可信
供试品溶液-2024042421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%
5min11945-19450.9894.63118.490.994.62118.55
21956-19560.9940.99
324199-2419912.29912.30
421730-2173011.04411.04
51367-13670.6950.69
63423-34231.7401.74
10min176652-7665238.95841.967.8638.9641.987.87
279840-7984040.57940.58
388699-8869945.08145.15
479330-7933040.31940.38
592597-9259747.06247.07
678217-7821739.75439.76
15min1102608-10260852.15057.736.9352.3757.986.93
2116906-11690659.41759.65
3121333-12133361.66761.99
4110071-11007155.94356.23
5122320-12232062.16962.43
6108225-10822555.00555.24
20min1116420-11642059.17063.375.7659.6863.955.78
2130390-13039066.27166.83
3131416-13141666.79267.45
4120562-12056261.27561.87
5131559-13155966.86567.48
6117809-11780959.87660.41
30min1120168-12016861.07564.884.8461.9265.814.86
2131647-13164766.90967.84
3132548-13254867.36768.40
4123576-12357662.80763.74
5135083-13508368.65669.64
6122897-12289762.46263.33
45min1120077-12007761.02966.535.8362.2167.825.84
2136410-13641069.33070.63
3136034-13603469.13970.55
4128404-12840465.26166.55
5139544-13954470.92372.29
6124898-12489863.47964.69
60min1123499-12349962.76867.004.9464.2968.664.95
2139534-13953470.91872.60
3136327-13632769.28871.08
4130189-13018966.16867.82
5136023-13602369.13370.89
6125323-12532363.69565.26
极限1122047-12204762.03069.348.8663.9071.388.77
2145628-14562874.01576.10
3145325-14532573.86176.04
4137304-13730469.78571.80
5147360-14736074.89677.04
6120967-12096761.48163.40
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品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2000
标示量(mg)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992123482130382114132119662116872120900.30
216.002120362143912132140.79
单位质量响应值RSD%判断
13263.9113325.880.33数据可信
供试品溶液-2024042421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%
5min124580-2458012.38814.4328.0412.3914.4428.04
222299-2229911.23911.24
327783-2778314.00214.00
439198-3919819.75619.76
520238-2023810.20010.20
637739-3773919.02019.02
10min181895-8189541.27544.0015.8841.3444.0815.82
2103788-10378852.30852.37
3105722-10572253.28353.36
477176-7717638.89639.01
581549-8154941.10041.16
673721-7372137.15537.26
15min1115198-11519858.05962.354.7758.3662.684.78
2129959-12995965.49865.85
3129943-12994365.49065.86
4119278-11927860.11560.44
5125274-12527463.13763.42
6122653-12265361.81662.13
20min1132986-13298667.02468.023.0467.6468.693.04
2142130-14213071.63372.35
3134996-13499668.03768.77
4131158-13115866.10366.76
5136785-13678568.93969.57
6131704-13170466.37867.03
30min1133644-13364467.35670.013.7168.3571.063.70
2144170-14417072.66173.78
3140186-14018670.65371.77
4139419-13941970.26671.29
5144072-14407272.61173.63
6131931-13193166.49267.52
45min1129656-12965665.34668.035.1766.7169.465.13
2144801-14480172.97974.50
3135658-13565868.37169.88
4140248-14024870.68472.10
5133909-13390967.48968.91
6125562-12556263.28264.68
60min1121428-12142861.19964.777.6562.9366.597.51
2139192-13919270.15272.08
3127525-12752564.27266.16
4141512-14151271.32173.13
5124395-12439562.69464.49
6117069-11706959.00260.75
极限1110978-11097855.93260.119.2858.0062.289.09
2126482-12648263.74666.06
3124616-12461662.80665.05
4134682-13468267.87970.09
5113284-11328457.09459.24
6105520-10552053.18155.25
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