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%
110.146624566223661926620866317662370.08
210.106622366162661920.07
单位质量响应值RSD%判断
6532.256553.660.24数据可信
供试品溶液-2025311521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%
5min168940-6894094.73489.565.0994.7389.565.09
259574-5957481.86481.86
366589-6658991.50391.50
463290-6329086.97086.97
567075-6707592.17192.17
665602-6560290.14790.15
10min170191-7019196.45394.991.8096.6195.141.80
268229-6822993.75793.89
370222-7022296.49696.65
468895-6889594.67294.82
567192-6719292.33292.49
670015-7001596.21196.36
15min170237-7023796.51694.831.6496.8495.141.65
268131-6813193.62293.92
369938-6993896.10696.42
468798-6879894.53994.84
567325-6732592.51592.82
669618-6961895.66695.98
20min170272-7027296.56494.811.7697.0495.281.76
268143-6814393.63994.09
369540-6954095.55996.03
468528-6852894.16894.63
567274-6727492.44592.91
670213-7021396.48396.95
30min170174-7017496.43094.521.8397.0795.141.83
268083-6808393.55694.16
369768-6976895.87296.50
468533-6853394.17594.79
566764-6676491.74492.36
669388-6938895.35095.98
极限169273-6927395.19294.341.4495.9995.121.44
267936-6793693.35494.12
369281-6928195.20396.00
468574-6857494.23195.01
567117-6711792.22993.00
669730-6973095.82096.61
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%
110.146608766144661556626466117661530.11
210.106606466097660800.04
单位质量响应值RSD%判断
6523.966542.570.21数据可信
供试品溶液-2025311521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%
5min165789-6578990.53892.472.1390.5492.472.13
266466-6646691.47091.47
369858-6985896.13896.14
466871-6687192.02792.03
567586-6758693.01193.01
666585-6658591.63491.63
10min167264-6726492.56893.331.3092.7293.491.30
267201-6720192.48192.63
369518-6951895.67095.83
467583-6758393.00793.16
567968-6796893.53793.69
667387-6738792.73792.89
15min167471-6747192.85393.191.4593.1693.501.46
267133-6713392.38892.69
369575-6957595.74896.07
467100-6710092.34292.65
568004-6800493.58693.90
667008-6700892.21692.52
20min167252-6725292.55293.321.5693.0193.781.56
267634-6763493.07793.54
369746-6974695.98496.46
466712-6671291.80892.27
568113-6811393.73694.20
667391-6739192.74393.20
30min167364-6736492.70693.461.4293.3294.081.42
267587-6758793.01393.63
369648-6964895.84996.49
466968-6696892.16192.78
568345-6834594.05694.68
667552-6755292.96493.58
极限166957-6695792.14693.051.7292.9193.821.72
266938-6693892.11992.89
369743-6974395.98096.78
466628-6662891.69392.46
568091-6809193.70694.49
667323-6732392.64993.42
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%
110.146627166155661676630666299662400.12
210.106621366231662220.02
单位质量响应值RSD%判断
6532.546556.630.27数据可信
供试品溶液-2025311521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%
5min166893-6689391.89892.380.6991.9092.390.69
267163-6716392.26992.27
367918-6791893.30793.31
466656-6665691.57391.57
567597-6759792.86692.87
667255-6725592.39692.40
10min168146-6814693.62094.140.5093.7794.290.50
268326-6832693.86794.02
368924-6892494.68994.84
468217-6821793.71793.87
568888-6888894.63994.79
668635-6863594.29294.45
15min168402-6840293.97194.120.4194.2894.440.41
268348-6834893.89794.21
368683-6868394.35794.67
468100-6810093.55793.87
568858-6885894.59894.91
668682-6868294.35694.67
20min168210-6821093.70894.040.3694.1794.510.36
268388-6838893.95294.42
368687-6868794.36394.83
468308-6830893.84294.31
568815-6881594.53995.01
668298-6829893.82994.30
30min168234-6823493.74194.300.5194.3694.920.51
268558-6855894.18694.81
368771-6877194.47895.11
468321-6832193.86094.48
569177-6917795.03695.66
668779-6877994.48995.11
极限168271-6827193.79194.210.3594.5795.000.35
268605-6860594.25095.03
368562-6856294.19194.98
468364-6836493.91994.70
568899-6889994.65495.44
668772-6877294.48095.26
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