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DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.182122732124182124352121342119312122380.10
216.222133112133962133540.03
单位质量响应值RSD%判断
13117.3113153.760.20数据可信
供试品溶液-2022060501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%
5min18041-80414.0962.16116.154.102.16116.16
26129-61293.1223.12
3-0.0000.00
4-0.0000.00
511246-112465.7295.73
6-0.0000.00
10min180675-8067541.09537.958.0141.1237.968.00
267649-6764934.46034.48
380708-8070841.11241.11
477457-7745739.45639.46
572379-7237936.86936.90
668106-6810634.69334.69
15min1105795-10579553.89154.053.5054.1454.273.51
2101756-10175651.83452.04
3109082-10908255.56555.79
4106142-10614254.06854.29
5111366-11136656.72956.97
6102478-10247852.20152.39
20min1116995-11699559.59659.493.1860.1560.013.19
2111376-11137656.73457.23
3120051-12005161.15361.69
4118855-11885560.54461.06
5120196-12019661.22761.78
6113215-11321557.67158.15
30min1113300-11330057.71459.353.5458.6060.213.53
2112487-11248757.30058.11
3120447-12044761.35562.23
4118383-11838360.30361.16
5121607-12160761.94662.84
6112885-11288557.50358.31
45min1116417-11641759.30261.233.0960.5062.413.08
2116511-11651159.35060.48
3124035-12403563.18264.40
4123881-12388163.10464.29
5122677-12267762.49163.73
6117650-11765059.93061.05
60min1120181-12018161.21962.993.1662.7564.523.14
2118060-11806060.13961.60
3127064-12706464.72566.29
4123152-12315262.73364.27
5127706-12770665.05266.64
6125812-12581264.08865.54
极限1124425-12442563.38165.422.5865.2567.292.58
2124490-12449063.41465.21
3131502-13150266.98668.91
4131080-13108066.77168.66
5131003-13100366.73268.68
6128081-12808165.24367.05
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DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.182132922129772129152130332128832130200.08
216.222130502130932130720.02
单位质量响应值RSD%判断
13165.6413136.370.16数据可信
供试品溶液-2022060501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%
5min1-0.0002.53152.980.002.53152.97
22908-29081.4801.48
33603-36031.8331.83
43160-31601.6081.61
5-0.0000.00
620134-2013410.24410.24
10min179143-7914340.26738.045.5240.2738.065.48
274028-7402837.66537.67
374255-7425537.78037.79
471464-7146436.36036.37
580070-8007040.73940.74
669653-6965335.43935.50
15min1108612-10861255.26153.402.4255.4853.632.41
2103919-10391952.87353.09
3102727-10272752.26752.49
4103810-10381052.81853.03
5107714-10771454.80455.03
6102984-10298452.39752.65
20min1119178-11917860.63758.582.6461.1759.102.64
2114295-11429558.15258.66
3110815-11081556.38256.89
4113688-11368857.84458.35
5114821-11482158.42058.95
6117988-11798860.03160.58
30min1120387-12038761.25259.551.5762.1260.401.56
2115361-11536158.69559.53
3117225-11722559.64360.47
4116260-11626059.15259.98
5117421-11742159.74360.60
6115637-11563758.83559.71
45min1126018-12601864.11761.432.6165.3262.612.59
2122347-12234762.24963.41
3117804-11780459.93861.09
4117542-11754259.80460.96
5120458-12045861.28862.48
6120245-12024561.18062.38
60min1127013-12701364.62362.691.7566.1964.211.75
2123077-12307762.62164.13
3121771-12177161.95663.44
4120748-12074861.43662.92
5122895-12289562.52864.06
6123764-12376462.97064.52
极限1131160-13116066.73366.141.5968.6668.001.55
2133370-13337067.85869.71
3128534-12853465.39767.23
4129298-12929865.78667.61
5129989-12998966.13768.01
6127577-12757764.91066.81
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