替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1107.65760475745225749805738285739155746580.16
2107.25796575773595785080.29
单位质量响应值RSD%判断
5340.695396.530.74数据可信
供试品溶液-25071401批-pH4.0(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1387529-38752963.92861.054.1763.9361.054.18
2377426-37742662.26162.26
3346825-34682557.21357.21
4355705-35570558.67858.68
5375607-37560761.96161.96
6377420-37742062.26062.26
10min1422692-42269269.72967.502.1769.8467.612.17
2409937-40993767.62567.73
3405043-40504366.81766.91
4396755-39675565.45065.55
5406277-40627767.02167.12
6414560-41456068.38768.49
15min1439855-43985572.56071.511.3472.7871.721.35
2433663-43366371.53971.75
3428487-42848770.68570.89
4426002-42600270.27570.48
5432755-43275571.38971.60
6440256-44025672.62672.84
20min1455048-45504875.06674.080.9275.4174.410.93
2447590-44759073.83674.17
3444986-44498673.40673.73
4444899-44489973.39273.72
5449205-44920574.10274.44
6452676-45267674.67575.01
30min1472685-47268577.97676.581.4578.4477.041.45
2468519-46851977.28877.75
3463241-46324176.41876.86
4452595-45259574.66275.11
5464028-46402876.54877.01
6464237-46423776.58277.05
45min1483969-48396979.83778.721.5780.4479.311.57
2476577-47657778.61879.21
3477642-47764278.79379.37
4463255-46325576.42076.99
5483152-48315279.70280.29
6478727-47872778.97279.56
60min1488723-48872380.62179.971.2981.3580.681.29
2486855-48685580.31381.03
3477673-47767378.79979.50
4476053-47605378.53179.23
5489074-48907480.67981.40
6490143-49014380.85681.58
90min1496588-49658881.91981.381.6282.7982.231.62
2496200-49620081.85582.71
3481079-48107979.36080.20
4486011-48601180.17481.00
5498520-49852082.23883.09
6501506-50150682.73083.59
120min1502569-50256982.90582.631.5783.9183.621.57
2503238-50323883.01684.00
3489627-48962780.77181.74
4493578-49357881.42282.38
5505802-50580283.43984.43
6510707-51070784.24885.24
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1512926-51292684.61484.531.0285.7585.651.02
2508583-50858383.89885.02
3508148-50814883.82684.93
4508181-50818183.83184.93
5515754-51575485.08186.21
6520971-52097185.94187.08
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1107.65828835823415826055818275840865827480.15
2107.25900055867885883960.39
单位质量响应值RSD%判断
5415.875488.770.95数据可信
供试品溶液-25071501批-pH4.0(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1422032-42203268.55265.874.1068.5565.874.10
2414216-41421667.28367.28
3405907-40590765.93365.93
4412492-41249267.00367.00
5404195-40419565.65565.65
6374250-37425060.79160.79
10min1458859-45885974.53472.571.4974.6572.681.49
2449130-44913072.95473.07
3442397-44239771.86071.97
4443636-44363672.06172.17
5446016-44601672.44872.56
6440634-44063471.57471.68
15min1476040-47604077.32575.711.5777.5675.941.57
2474029-47402976.99877.23
3458104-45810474.41174.64
4460278-46027874.76575.00
5464239-46423975.40875.64
6463961-46396175.36375.58
20min1490365-49036579.65277.711.5680.0278.061.56
2480912-48091278.11678.48
3467392-46739275.92076.27
4477104-47710477.49877.85
5477834-47783477.61677.97
6476784-47678477.44677.79
30min1497244-49724480.76979.151.4681.2779.631.46
2488789-48878979.39679.89
3475826-47582677.29077.77
4490522-49052279.67780.16
5486833-48683379.07879.56
6484307-48430778.66879.14
45min1508119-50811982.53680.562.1483.1781.182.13
2508638-50863882.62083.24
3482305-48230578.34278.95
4496111-49611180.58581.20
5490102-49010279.60980.23
6490579-49057979.68680.29
60min1511901-51190183.15081.791.9383.9282.541.92
2516767-51676783.94084.70
3489733-48973379.54980.29
4502987-50298781.70282.45
5498231-49823180.92981.68
6501458-50145881.45482.19
90min1517374-51737484.03983.131.5384.9584.021.53
2524758-52475885.23886.14
3504130-50413081.88882.76
4509960-50996082.83583.72
5507123-50712382.37483.26
6507172-50717282.38283.26
120min1523412-52341285.02083.731.6286.0784.751.62
2525863-52586385.41886.46
3506141-50614182.21483.22
4518329-51832984.19485.22
5507520-50752082.43883.46
6511452-51145283.07784.09
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1528890-52889085.90984.931.1787.1086.101.17
2525610-52561085.37786.56
3512548-51254883.25584.40
4526488-52648885.51986.69
5518624-51862484.24285.40
6524944-52494485.26886.42
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