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%
1 113.08782587829878678785787891878540.04
2 113.08717887299872380.10
单位质量响应值RSD%判断
777.47772.020.50数据可信
供试品溶液-1批-pH6.8(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%
5min171720-7172081.98379.813.4981.9879.813.49
269336-6933679.25879.26
369625-6962579.58979.59
473264-7326483.74883.75
568711-6871178.54478.54
666269-6626975.75275.75
10min178853-7885390.13787.112.4090.2787.242.40
275242-7524286.00986.14
374317-7431784.95285.08
477640-7764088.75088.89
574506-7450685.16885.30
676666-7666687.63787.76
15min179850-7985091.27788.552.2691.5688.832.25
275969-7596986.84087.12
375167-7516785.92486.20
478436-7843689.66089.95
576987-7698788.00488.28
678381-7838189.59889.87
20min180183-8018391.65789.122.2692.1089.542.25
276457-7645787.39887.82
375507-7550786.31286.73
478938-7893890.23490.67
577660-7766088.77389.19
679024-7902490.33390.75
30min180844-8084492.41390.202.3193.0090.772.31
277234-7723488.28688.85
376251-7625187.16387.72
480251-8025191.73592.32
578869-7886990.15590.72
680000-8000091.44892.02
45min181427-8142793.07990.952.2293.8391.672.22
278201-7820189.39290.10
376823-7682387.81788.52
480511-8051192.03292.77
579500-7950090.87791.59
680914-8091492.49393.22
60min181261-8126192.89091.332.1793.7992.202.16
278714-7871489.97890.84
377023-7702388.04588.90
481088-8108892.69293.59
579993-7999391.44092.31
681293-8129392.92693.80
极限182209-8220993.97392.192.3295.0393.222.31
279116-7911690.43891.45
377706-7770688.82689.83
481906-8190693.62794.68
580790-8079092.35193.37
682189-8218993.95094.98
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%
1 113.08697687194870228713087051870750.11
2 113.08742687361873940.06
单位质量响应值RSD%判断
770.58773.400.26数据可信
供试品溶液-2批-pH6.8(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%
5min155690-5569063.88676.739.0963.8976.739.09
271769-7176982.33282.33
369075-6907579.24179.24
469521-6952179.75379.75
564251-6425173.70773.71
670993-7099381.44181.44
10min167065-6706576.93585.045.1477.0485.165.14
278249-7824989.76589.90
375791-7579186.94587.08
474374-7437485.32085.45
573612-7361284.44684.57
675666-7566686.80286.94
15min172735-7273583.44087.612.9183.6787.872.92
279322-7932290.99691.28
377553-7755388.96789.24
475920-7592087.09387.37
575604-7560486.73186.99
677064-7706488.40688.69
20min174875-7487585.89588.582.2386.2789.002.24
279558-7955891.26791.71
378368-7836889.90290.33
476833-7683388.14188.56
575835-7583586.99687.40
677837-7783789.29389.72
30min176785-7678588.08689.782.0388.6090.342.03
280305-8030592.12492.71
379461-7946191.15691.73
477653-7765389.08189.65
576329-7632987.56388.12
679034-7903490.66691.24
45min178169-7816989.67390.852.0690.3491.562.06
280527-8052792.37893.12
380848-8084892.74793.47
478190-7819089.69890.41
576954-7695488.28088.98
680458-8045892.29993.03
60min179341-7934191.01891.662.1291.8392.522.12
280937-8093792.84993.75
381774-8177493.80994.69
478378-7837889.91390.78
577651-7765189.07989.93
681317-8131793.28594.17
极限180316-8031692.13692.842.2093.1093.862.20
281735-8173593.76494.82
382413-8241394.54295.58
479128-7912890.77491.79
578837-7883790.44091.43
683161-8316195.40096.44
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%
1 113.08723587378873858745287472873840.11
2 113.08780787908878580.09
单位质量响应值RSD%判断
773.31777.500.39数据可信
供试品溶液-49G03N批-pH6.8(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%
5min166313-6631375.73776.521.5275.7476.521.53
266556-6655676.01576.01
366643-6664376.11476.11
466944-6694476.45876.46
566517-6651775.97075.97
669035-6903578.84678.85
10min173572-7357284.02885.061.6284.1585.181.62
273581-7358184.03884.16
374593-7459385.19485.32
474708-7470885.32585.45
573703-7370384.17884.30
676695-7669587.59587.73
15min178263-7826389.38690.441.0289.6590.701.03
278606-7860689.77790.04
379485-7948590.78191.05
479302-7930290.57290.84
578890-7889090.10290.37
680550-8055091.99892.28
20min180820-8082092.30693.540.9792.7293.960.97
281229-8122992.77393.19
382322-8232294.02194.44
482189-8218993.87094.29
581851-8185193.48493.90
683015-8301594.81395.24
30min183752-8375295.65596.730.8896.2297.310.88
283761-8376195.66596.24
385216-8521697.32797.90
484954-8495497.02897.60
585092-8509297.18597.76
685411-8541197.54998.14
45min185238-8523897.35298.460.9898.0899.200.98
285121-8512197.21897.95
387207-8720799.601100.34
486561-8656198.86399.60
586698-8669899.01999.75
686446-8644698.73299.48
60min185805-8580597.99999.420.9198.89100.320.91
286340-8634098.61099.50
387772-87772100.246101.15
487576-87576100.022100.93
587318-8731899.727100.63
687460-8746099.890100.81
极限186820-8682099.159100.230.87100.21101.300.87
286813-8681399.151100.21
388623-88623101.218102.29
488217-88217100.754101.82
588014-88014100.522101.59
688073-88073100.590101.67
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