褪黑素颗粒项目信息
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520023-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
110.076623666359664376638966422663690.13
210.116629866285662920.02
单位质量响应值RSD%判断
6590.766557.070.37数据可信
供试品溶液-AFP05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%
5min166121-6612190.43393.612.6990.4393.612.69
271498-7149897.78797.79
367613-6761392.47392.47
469066-6906694.46194.46
567510-6751092.33392.33
668865-6886594.18694.19
10min169603-6960395.19596.431.1795.3596.581.17
271725-7172598.09798.26
369835-6983595.51295.67
470941-7094197.02597.18
569990-6999095.72495.88
670922-7092296.99997.16
15min169579-6957995.16296.011.1195.4796.331.11
271322-7132297.54697.87
369190-6919094.63094.94
470488-7048896.40596.72
569970-6997095.69796.01
670656-7065696.63596.95
20min169620-6962095.21895.791.0495.6996.261.04
271213-7121397.39797.89
369222-6922294.67495.15
470555-7055596.49796.98
569842-6984295.52295.99
669757-6975795.40695.89
30min169325-6932594.81595.351.1795.4495.991.17
270778-7077896.80297.45
369303-6930394.78595.41
470372-7037296.24796.89
568553-6855393.75994.39
669973-6997395.70196.34
褪黑素颗粒项目信息
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520023-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
110.076622266345662446636466330663010.10
210.116640366321663620.09
单位质量响应值RSD%判断
6584.016564.000.22数据可信
供试品溶液-AFP05批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min172708-7270899.44098.910.6199.4498.910.61
272167-7216798.70098.70
372124-7212498.64198.64
471607-7160797.93497.93
572574-7257499.25799.26
672738-7273899.48199.48
10min173115-7311599.99799.230.60100.1699.390.60
272269-7226998.84099.00
372735-7273599.47799.64
472010-7201098.48598.65
572270-7227098.84199.01
672924-7292499.73599.90
15min172851-7285199.63699.030.3999.9799.360.39
272306-7230698.89099.22
372649-7264999.35999.69
472162-7216298.69399.02
572175-7217598.71199.04
672313-7231398.90099.23
20min172705-7270599.43698.740.4199.9399.240.41
271999-7199998.47098.96
372400-7240099.01999.51
472009-7200998.48498.98
571994-7199498.46498.96
672072-7207298.57099.07
30min172653-7265399.36598.540.51100.0399.200.51
271834-7183498.24598.90
372272-7227298.84499.50
471648-7164897.99098.65
571868-7186898.29198.95
672041-7204198.52899.19
褪黑素颗粒项目信息
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520023-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
110.076638066537664916652466550664960.11
210.116637066393663820.03
单位质量响应值RSD%判断
6603.386565.970.41数据可信
供试品溶液-AFP05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%
5min169271-6927194.58693.451.1594.5993.451.15
268087-6808792.97092.97
367247-6724791.82391.82
468097-6809792.98392.98
568688-6868893.79093.79
669238-6923894.54194.54
10min170322-7032296.02195.530.7996.1895.690.79
269964-6996495.53395.69
368889-6888994.06594.22
470000-7000095.58295.74
570383-7038396.10596.26
670213-7021395.87396.03
15min170445-7044596.18995.610.6496.5195.930.64
269857-6985795.38795.70
369351-6935194.69695.01
469935-6993595.49395.81
570591-7059196.38996.71
669948-6994895.51195.83
20min170681-7068196.51295.590.7596.9996.060.75
269708-6970895.18395.66
369259-6925994.57095.04
469747-6974795.23695.71
570355-7035596.06796.54
670281-7028195.96596.44
30min170570-7057096.36095.300.7497.0095.940.74
269627-6962795.07295.70
369058-6905894.29694.92
469628-6962895.07495.71
570124-7012495.75196.39
669772-6977295.27095.91
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