乌帕替尼缓释片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1151746761743891751211750151747901747980.17
215.031733081742841737960.40
单位质量响应值RSD%判断
11653.2011563.270.55数据可信
供试品溶液-2025032321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%
30min126774-2677413.76714.263.2513.7714.263.24
227497-2749714.13914.14
328612-2861214.71214.71
428023-2802314.40914.41
528768-2876814.79214.79
626666-2666613.71213.71
60min147946-4794624.65425.482.6324.6825.502.63
251352-5135226.40526.43
350798-5079826.12026.14
449584-4958425.49625.52
548843-4884325.11525.14
648777-4877725.08125.10
120min177821-7782140.01540.671.2440.0840.731.24
279375-7937540.81440.88
380306-8030641.29341.36
479571-7957140.91540.98
577992-7799240.10340.17
679467-7946740.86140.93
240min1117620-11762060.48061.170.6960.6161.300.70
2118999-11899961.18961.32
3120209-12020961.81161.95
4118914-11891461.14561.28
5119059-11905961.21961.35
6118958-11895861.16861.30
360min1142609-14260973.32974.070.9373.5674.300.93
2144995-14499574.55674.79
3145543-14554374.83775.08
4144313-14431374.20574.44
5142239-14223973.13873.37
6144604-14460474.35574.59
480min1159230-15923081.87582.500.7782.2382.860.77
2160537-16053782.54782.91
3161385-16138582.98383.35
4160919-16091982.74483.10
5158721-15872181.61381.97
6161865-16186583.23083.59
600min1169354-16935487.08187.970.8887.5788.460.88
2171854-17185488.36688.87
3172997-17299788.95489.46
4171435-17143588.15188.65
5169206-16920687.00587.50
6171603-17160388.23788.73
720min1175291-17529190.13491.150.7890.7791.800.78
2177710-17771091.37792.02
3178443-17844391.75492.41
4178066-17806691.56192.21
5175795-17579590.39391.03
6178342-17834291.70292.35
960min1184160-18416094.69495.750.9195.4896.550.91
2186042-18604295.66296.46
3188072-18807296.70697.51
4186710-18671096.00596.80
5184398-18439894.81695.61
6187933-18793396.63497.43
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1187680-18768096.50497.270.7197.4598.230.71
2189389-18938997.38398.34
3190056-19005697.72698.69
4189913-18991397.65298.61
5187395-18739596.35797.30
6190625-19062598.01898.98
1440min1189378-18937897.37798.331.2698.4899.451.25
2190361-19036197.88399.00
3191498-19149898.46799.60
4191266-19126698.34899.47
5189172-18917297.27198.38
6195742-195742100.649101.77
极限1189182-18918297.27698.150.7398.5499.430.74
2190268-19026897.83599.12
3191942-19194298.69599.99
4191280-19128098.35599.64
5189730-18973097.55898.83
6192838-19283899.156100.45
乌帕替尼缓释片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1151740861733801732621736301741691737050.24
215.031736061736741736400.03
单位质量响应值RSD%判断
11580.3311552.890.17数据可信
供试品溶液-2025032321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%
30min129397-2939715.17014.842.4915.1714.842.51
228490-2849014.70214.70
328722-2872214.82214.82
428409-2840914.66014.66
529739-2973915.34615.35
627759-2775914.32514.32
60min150684-5068426.15525.892.1826.1825.912.17
249139-4913925.35825.38
351309-5130926.47726.50
449651-4965125.62225.65
551330-5133026.48826.51
648861-4886125.21425.24
120min179656-7965641.10541.081.2941.1741.141.29
278764-7876440.64540.71
380295-8029541.43541.50
478830-7883040.67940.75
581269-8126941.93842.01
678786-7878640.65740.72
240min1118520-11852061.16161.051.0461.3061.191.04
2117033-11703360.39360.53
3118726-11872661.26761.40
4117349-11734960.55760.69
5120438-12043862.15162.29
6117803-11780360.79160.92
360min1142420-14242073.49473.821.1973.7374.061.19
2141579-14157973.06073.30
3143318-14331873.95774.20
4141310-14131072.92173.16
5145910-14591075.29575.54
6143717-14371774.16374.40
480min1157453-15745381.25282.081.5181.6182.441.51
2157336-15733681.19181.55
3158775-15877581.93482.30
4157977-15797781.52281.88
5163739-16373984.49584.86
6159077-15907782.09082.45
600min1167748-16774886.56487.371.1387.0687.871.13
2166743-16674386.04686.54
3169768-16976887.60788.11
4169058-16905887.24087.73
5172012-17201288.76589.27
6170564-17056488.01788.51
720min1175449-17544990.53891.811.3191.1892.451.31
2175424-17542490.52591.16
3178151-17815191.93392.58
4177423-17742391.55792.20
5181193-18119393.50294.16
6179809-17980992.78893.43
960min1182483-18248394.16895.021.0994.9695.821.09
2182062-18206293.95194.74
3184794-18479495.36196.16
4182900-18290094.38395.17
5187168-18716896.58697.40
6185444-18544495.69696.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1185665-18566595.81097.001.3496.7697.961.33
2185252-18525295.59796.54
3188769-18876997.41298.37
4186705-18670596.34797.30
5191476-19147698.80999.78
6190006-19000698.05099.01
1440min1188007-18800797.01997.961.3098.1399.081.30
2186777-18677796.38497.49
3190406-19040698.25799.38
4188958-18895897.50998.62
5193683-19368399.948101.09
6191192-19119298.66299.78
极限1187609-18760996.81398.081.3098.0899.361.30
2187213-18721396.60997.87
3190432-19043298.27099.55
4189513-18951397.79699.07
5193446-19344699.825101.13
6192148-19214899.156100.44
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