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%
115.762092332085132087612087882089282088450.13
215.802084092084862084480.03
单位质量响应值RSD%判断
13251.5913192.910.32数据可信
供试品溶液-2024042421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%
5min118942-189429.59910.3431.169.6010.3431.14
225076-2507612.70812.71
331043-3104315.73115.73
416507-165078.3658.37
515110-151107.6577.66
615747-157477.9807.98
10min1163463-16346382.83782.711.9182.8982.771.90
2166325-16632584.28784.36
3159576-15957680.86780.95
4163601-16360182.90782.95
5166712-16671284.48384.53
6159645-15964580.90280.95
15min1183430-18343092.95594.752.4493.4795.272.43
2190358-19035896.46697.01
3181110-18111091.78092.32
4190190-19019096.38196.89
5192350-19235097.47697.99
6184445-18444593.47093.96
20min1186875-18687594.70197.051.9695.7398.091.94
2190932-19093296.75797.83
3188177-18817795.36196.41
4195528-19552899.086100.13
5196065-19606599.358100.41
6191466-19146697.02898.04
30min1184847-18484793.67397.252.6095.2398.832.58
2193659-19365998.13999.75
3188267-18826795.40796.98
4197534-197534100.103101.70
5196766-19676699.714101.32
6190369-19036996.47298.02
45min1182483-18248392.47596.382.2994.5598.502.27
2188738-18873895.64597.80
3189434-18943495.99898.10
4193746-19374698.183100.33
5193510-19351098.064100.22
6193184-19318497.89899.99
极限1184064-18406493.27796.591.9995.8799.251.96
2188337-18833795.44298.13
3191012-19101296.79899.44
4193615-19361598.117100.81
5193266-19326697.940100.64
6193328-19332897.971100.60
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%
115.762097112100512097842074642097622093540.51
215.802068492070482069480.07
单位质量响应值RSD%判断
13283.8813097.971.00数据可信
供试品溶液-2024042421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%
5min120622-2062210.47613.4348.5910.4813.4348.57
223972-2397212.17712.18
348275-4827524.52324.52
414420-144207.3257.33
516652-166528.4598.46
634704-3470417.62917.63
10min1166867-16686784.76683.282.9384.8283.362.91
2167662-16766285.17085.24
3164172-16417283.39783.53
4162140-16214082.36582.41
5167585-16758585.13185.18
6155218-15521878.84978.95
15min1185679-18567994.32393.611.7194.8594.141.67
2183465-18346593.19893.74
3180033-18003391.45592.05
4184590-18459093.76994.27
5189311-18931196.16896.69
6182526-18252692.72193.26
20min1186687-18668794.83595.601.1995.8996.661.19
2191912-19191297.48998.55
3188807-18880795.91297.02
4186345-18634594.66195.68
5189182-18918296.10297.16
6186176-18617694.57595.63
30min1188774-18877495.89595.620.7997.4797.210.78
2188885-18888595.95197.55
3186963-18696394.97596.62
4186194-18619494.58496.13
5188307-18830795.65897.25
6190332-19033296.68698.26
45min1184689-18468993.82095.341.5095.9397.451.48
2189060-18906096.04098.17
3187830-18783095.41597.58
4186015-18601594.49396.56
5192464-19246497.76999.89
6185975-18597594.47396.59
极限1186441-18644194.71094.541.4897.3497.191.44
2183869-18386993.40396.07
3183042-18304292.98395.68
4185216-18521694.08796.68
5190659-19065996.85299.52
6187406-18740695.20097.84
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