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)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%
115.992115732115242114462112472115772114730.07
216.002136102132672134380.12
单位质量响应值RSD%判断
13225.3313339.880.61数据可信
供试品溶液-2024042721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%
5min182094-8209441.41420.7753.2341.4120.7753.23
250115-5011525.28125.28
332356-3235616.32316.32
427126-2712613.68413.68
529575-2957514.92014.92
625766-2576612.99813.00
10min1188647-18864795.16688.613.8495.4088.723.90
2172668-17266887.10587.25
3169413-16941385.46385.55
4173366-17336687.45787.53
5173478-17347887.51487.60
6176323-17632388.94989.02
15min1190284-19028495.99297.190.7196.7597.800.65
2193252-19325297.48998.11
3193563-19356397.64698.21
4192264-19226496.99197.55
5192448-19244897.08497.65
6194190-19419097.96298.53
20min1197080-19708099.42099.170.30100.71100.320.35
2197316-19731699.539100.71
3196300-19630099.027100.13
4195707-19570798.72899.83
5196379-19637999.067100.18
6196739-19673999.248100.36
30min1193214-19321497.47099.341.4199.31101.041.35
2199245-199245100.512102.23
3199653-199653100.718102.38
4193850-19385097.79199.44
5198393-198393100.083101.74
6197128-19712899.444101.11
45min1194355-19435598.04699.431.65100.43101.681.60
2199512-199512100.647102.92
3199317-199317100.549102.77
4191808-19180896.76198.95
5198674-198674100.224102.44
6198974-198974100.376102.59
极限1191158-19115896.43399.192.1699.36101.992.08
2199051-199051100.415103.25
3200245-200245101.017103.79
4192043-19204396.87999.61
5201047-201047101.421104.19
6196157-19615798.955101.73
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)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%
115.992123362127162129622133832134672129730.23
216.002126622131052128840.15
单位质量响应值RSD%判断
13319.1413305.250.08数据可信
供试品溶液-2024042721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%
5min150281-5028125.30822.7544.1325.3122.7644.14
227879-2787914.03214.03
338900-3890019.58019.58
482641-8264141.59641.60
540502-4050220.38620.39
631040-3104015.62415.62
10min1172387-17238786.76988.503.6486.9188.623.70
2174009-17400987.58587.66
3174324-17432487.74387.85
4188060-18806094.65794.89
5176425-17642588.80188.91
6169724-16972485.42885.51
15min1194553-19455397.92597.420.7398.5598.040.67
2193687-19368797.49098.05
3194089-19408997.69298.29
4190723-19072395.99896.75
5194161-19416197.72898.33
6194087-19408797.69198.25
20min1198892-198892100.10999.481.07101.28100.641.10
2196514-19651498.913100.02
3197414-19741499.366100.50
4200748-200748101.044102.33
5194562-19456297.93099.08
6197728-19772899.524100.63
30min1200601-200601100.97099.711.14102.69101.421.10
2195360-19536098.33299.99
3198928-198928100.128101.82
4195821-19582198.564100.42
5197509-19750999.413101.11
6200396-200396100.866102.52
45min1200824-200824101.08299.761.96103.37102.021.90
2192214-19221496.74898.95
3199449-199449100.390102.64
4194649-19464997.974100.37
5200019-200019100.677102.92
6202021-202021101.684103.90
极限1197613-19761399.46698.962.23102.31101.782.14
2193203-19320397.24699.99
3200447-200447100.892103.70
4191220-19122096.24899.19
5194626-19462697.962100.77
6202582-202582101.967104.75
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