熊去氧胆酸颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.051002101009481008481007431004121006320.31
2 10.071006861005851006360.08
单位质量响应值RSD%判断
10013.139993.640.14数据可信
中间条件24月-供试品溶液-2023111721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%
5min176062-7606268.22751.2818.1268.2351.2818.13
257736-5773651.78951.79
356159-5615950.37450.37
444614-4461440.01940.02
552990-5299047.53247.53
655425-5542549.71649.72
10min198634-9863488.47478.8910.9988.8579.1811.01
293417-9341783.79584.08
396496-9649686.55786.84
474713-7471367.01767.24
580100-8010071.84972.11
684341-8434175.65475.93
15min1104673-10467393.89188.416.4394.7689.136.47
2101964-10196491.46192.21
3105835-10583594.93495.69
491291-9129181.88882.48
594244-9424484.53785.20
693350-9335083.73584.43
20min1107293-10729396.24192.623.9697.6393.834.03
2104998-10499894.18395.44
3107492-10749296.42097.71
497923-9792387.83788.89
5102726-10272692.14593.28
699081-9908188.87590.04
30min1104563-10456393.79394.212.0395.7295.942.08
2105505-10550594.63896.42
3108325-10832597.16798.99
4101898-10189891.40292.94
5105812-10581294.91396.56
6104056-10405693.33894.99
45min1106407-10640795.44795.861.2097.8998.111.26
2107092-10709296.06198.37
3109121-10912197.881100.24
4105390-10539094.53496.58
5107105-10710596.07398.24
6106082-10608295.15597.33
60min1106007-10600795.08894.791.5998.0797.581.63
2104234-10423493.49896.34
3108125-10812596.98899.90
4104066-10406693.34795.92
5107084-10708496.05498.76
6104558-10455893.78896.49
极限1110152-11015298.80699.821.27102.31103.131.22
2111603-111603100.108103.47
3112502-112502100.914104.36
4112292-112292100.726103.81
5112152-112152100.600103.84
6108977-10897797.752100.98
熊去氧胆酸颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.051006651001751004171004301004541004280.18
2 10.071005691009081007380.24
单位质量响应值RSD%判断
9992.8410003.770.08数据可信
中间条件24月-供试品溶液-2023111821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%
5min159842-5984253.70553.096.1453.7153.096.14
258570-5857052.56452.56
352173-5217346.82346.82
461403-6140355.10655.11
560942-6094254.69354.69
661982-6198255.62655.63
10min187612-8761278.62875.135.7078.9375.435.70
284673-8467375.99076.28
374703-7470367.04267.30
485884-8588477.07777.38
582538-8253874.07474.38
686889-8688977.97978.29
15min197183-9718387.21782.705.0687.9583.425.06
292676-9267683.17283.89
383884-8388475.28275.91
493222-9322283.66284.40
590530-9053081.24681.96
695421-9542185.63686.38
20min1100007-10000789.75286.754.2090.9787.924.21
297692-9769287.67488.85
390252-9025280.99782.05
497751-9775187.72788.93
593441-9344183.85985.03
6100834-10083490.49491.71
30min1100832-10083290.49289.134.2392.2190.784.24
2102258-10225891.77293.44
392169-9216982.71784.22
4100012-10001289.75691.44
596862-9686286.92988.56
6103738-10373893.10094.82
45min1104354-10435493.65389.794.6795.8791.934.65
2104060-10406093.38995.56
393456-9345683.87285.83
4100226-10022689.94892.13
595300-9530085.52787.64
6102884-10288492.33394.57
60min1102290-10229091.80090.244.1894.5492.894.19
2103910-10391093.25495.95
394220-9422084.55886.98
4100945-10094590.59393.28
596895-9689586.95989.55
6105039-10503994.26897.02
极限1109298-10929898.09098.880.78101.34102.020.79
2110829-11082999.464102.67
3109231-10923198.030100.93
4109994-10999498.714101.90
5111404-11140499.980103.05
6110293-11029398.983102.26
熊去氧胆酸颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.051007281001721007911004891002621004880.28
2 10.07100087999801000340.08
单位质量响应值RSD%判断
9998.819933.860.47数据可信
中间条件24月-供试品溶液-2023111921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%
5min141939-4193937.75941.0615.4937.7641.0615.50
239359-3935935.43735.44
349933-4993344.95744.96
457718-5771851.96651.97
540074-4007436.08036.08
644620-4462040.17340.17
10min176455-7645568.83669.779.9069.0570.009.91
271582-7158264.44864.65
381983-8198373.81374.06
489212-8921280.32180.61
567497-6749760.77060.97
678223-7822370.42770.65
15min189203-8920380.31382.004.6780.9182.624.72
288147-8814779.36279.92
391340-9134082.23782.90
498033-9803388.26389.00
586200-8620077.60978.15
693512-9351284.19384.81
20min198581-9858188.75689.062.8289.7990.132.86
295425-9542585.91586.91
399002-9900289.13690.25
4103824-10382493.47794.70
599226-9922689.33790.31
697450-9745087.73888.82
30min1106453-10645395.84494.781.5397.3896.341.59
2102672-10267292.44093.91
3105241-10524194.75396.36
4106972-10697296.31198.06
5104185-10418593.80295.27
6106088-10608895.51597.08
45min1108738-10873897.90197.591.2299.9799.681.13
2108228-10822897.44299.43
3106990-10699096.32798.47
4107690-10769096.95899.24
5110799-11079999.757101.74
6107882-10788297.13199.23
60min1110392-11039299.39097.391.22102.00100.031.18
2107515-10751596.80099.33
3106738-10673896.10198.77
4107866-10786697.11699.93
5107537-10753796.82099.36
6108995-10899598.133100.77
极限1108018-10801897.25397.360.63100.41100.540.52
2109193-10919398.311101.38
3107660-10766096.931100.14
4107245-10724596.55799.91
5108418-10841897.613100.69
6108319-10831997.524100.71
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