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%
115.762087922087372086482083882086232086380.08
215.802110802113922112360.11
单位质量响应值RSD%判断
13238.4513369.370.70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%
5min184815-8481542.71826.8130.2842.7226.8130.27
254098-5409827.24727.25
340001-4000120.14720.15
447040-4704023.69223.69
545716-4571623.02523.03
647737-4773724.04324.04
10min1182030-18203091.68192.334.6791.9292.484.68
2189305-18930595.34695.50
3167812-16781284.52084.63
4182176-18217691.75591.89
5186514-18651493.94094.07
6192082-19208296.74496.88
15min1192086-19208696.74696.742.8197.4997.402.82
2193954-19395497.68798.37
3185731-18573193.54594.13
4187915-18791594.64595.29
5191507-19150796.45597.10
6201239-201239101.356102.03
20min1192814-19281497.11398.343.1698.4099.543.16
2196057-19605798.74699.97
3186441-18644193.90395.00
4192313-19231396.86198.03
5199925-199925100.694101.88
6203921-203921102.707103.94
30min1192809-19280997.11099.353.5498.93101.103.53
2203674-203674102.583104.36
3188757-18875795.07096.69
4192547-19254796.97898.68
5199423-199423100.442102.19
6206378-206378103.945105.75
45min1189712-18971295.55198.562.4397.91100.862.40
2202002-202002101.741104.08
3195356-19535698.393100.54
4192016-19201696.71198.96
5194585-19458598.005100.31
6200442-200442100.955103.34
极限1190758-19075896.07799.042.5498.97101.892.51
2202015-202015101.747104.65
3195641-19564198.537101.23
4191583-19158396.49399.27
5197499-19749999.473102.32
6202390-202390101.936104.88
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%
115.762095082096502092192089432091242092890.14
215.802082152086222084180.14
单位质量响应值RSD%判断
13279.7613191.010.48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%
5min150033-5003325.33031.7536.2725.3331.7636.27
251910-5191026.28026.28
359864-5986430.30730.31
455940-5594028.32028.32
550088-5008825.35825.36
6108496-10849654.92754.93
10min1186939-18693994.64094.245.4994.7894.425.51
2167821-16782184.96185.11
3194451-19445198.44398.61
4181570-18157091.92292.08
5193447-19344797.93598.08
6192661-19266197.53797.84
15min1198580-198580100.53499.343.49101.20100.043.50
2185759-18575994.04394.66
3198727-198727100.608101.32
4191687-19168797.04497.71
5205828-205828104.203104.89
6196766-19676699.615100.46
20min1197928-197928100.20398.812.77101.43100.062.81
2185555-18555593.93995.08
3196976-19697699.722101.00
4192097-19209797.25198.46
5199163-199163100.829102.09
6199334-199334100.915102.32
30min1197777-197777100.12798.522.49101.91100.322.52
2186448-18644894.39296.05
3196251-19625199.354101.18
4191067-19106796.73098.48
5198810-198810100.650102.47
6197312-19731299.892101.85
45min1199089-199089100.79199.271.84103.13101.621.85
2194133-19413398.282100.47
3200053-200053101.279103.66
4190150-19015096.26698.55
5197053-19705399.760102.14
6196060-19606099.258101.77
极限1198339-198339100.41299.592.49103.31102.492.45
2195789-19578999.121101.85
3197460-19746099.967102.91
4189238-18923895.80498.62
5204256-204256103.407106.34
6195219-19521998.832101.90
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