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%
19.996562265720656926559665608656480.09
29.896564465502655730.16
单位质量响应值RSD%判断
6571.376630.230.64数据可信
供试品溶液-2025072621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%
5min169034-6903494.03493.980.7894.0393.980.78
268403-6840393.17493.17
368983-6898393.96493.96
469720-6972094.96894.97
569442-6944294.58994.59
668399-6839993.16993.17
10min170008-7000895.36095.960.7895.5296.110.78
269810-6981095.09195.25
370788-7078896.42396.58
471079-7107996.81996.98
570918-7091896.60096.76
670064-7006495.43795.59
15min170473-7047395.99496.240.6396.3196.560.63
270290-7029095.74496.06
370640-7064096.22196.54
471182-7118296.95997.28
571188-7118896.96897.29
670172-7017295.58495.90
20min169931-6993195.25596.190.8595.7396.670.85
270141-7014195.54196.01
370840-7084096.49496.97
471487-7148797.37597.86
571024-7102496.74497.22
670294-7029495.75096.22
30min170205-7020595.62996.020.8396.2696.650.83
270021-7002195.37896.01
370506-7050696.03996.68
471278-7127897.09097.73
571080-7108096.82197.46
669841-6984195.13395.77
极限169971-6997195.31095.880.8396.1096.680.83
269596-6959694.79995.59
370274-7027495.72396.52
471246-7124697.04797.85
570746-7074696.36697.17
670498-7049896.02896.82
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%
19.996566865708655616559365571656200.10
29.896557465489655320.10
单位质量响应值RSD%判断
6568.576626.090.62数据可信
供试品溶液-2025072621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%
5min165711-6571189.55490.401.4389.5590.401.43
265385-6538589.11089.11
366683-6668390.87990.88
467503-6750391.99692.00
567275-6727591.68691.69
665440-6544089.18589.18
10min167962-6796292.62293.901.1092.7794.041.10
268689-6868993.61393.76
368460-6846093.30193.45
469839-6983995.18095.33
569779-6977995.09895.25
668647-6864793.55693.70
15min168507-6850793.36594.431.2593.6794.741.25
268918-6891893.92594.23
368395-6839593.21293.52
470420-7042095.97296.28
570228-7022895.71096.02
669265-6926594.39894.70
20min168504-6850493.36194.491.2793.8294.961.27
268937-6893793.95194.41
368388-6838893.20393.66
470404-7040495.95096.42
570304-7030495.81496.28
669478-6947894.68895.15
30min168649-6864993.55894.321.0994.1794.941.09
268909-6890993.91394.53
368378-6837893.18993.81
470080-7008095.50996.14
570176-7017695.63996.27
669042-6904294.09494.71
极限168637-6863793.54294.421.2794.3195.201.27
268851-6885193.83494.61
368114-6811492.82993.60
470350-7035095.87796.67
570003-7000395.40496.19
669751-6975195.06095.84
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%
19.996576365816657656577965880658010.08
29.896553865421654800.13
单位质量响应值RSD%判断
6586.696620.830.37数据可信
供试品溶液-2025072621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%
5min167370-6737091.72591.720.7791.7291.720.77
268142-6814292.77692.78
366834-6683490.99590.99
466835-6683590.99691.00
567733-6773392.21992.22
667263-6726391.57991.58
10min168979-6897993.91594.360.7094.0794.510.70
270057-7005795.38395.54
368713-6871393.55393.70
469159-6915994.16094.31
569634-6963494.80794.96
669289-6928994.33794.49
15min169764-6976494.98494.620.8695.2994.930.86
270258-7025895.65795.97
369000-6900093.94494.25
469504-6950494.63094.94
569820-6982095.06095.37
668632-6863293.44393.75
20min169682-6968294.87394.560.6895.3495.020.68
270049-7004995.37295.85
368844-6884493.73294.20
469480-6948094.59795.06
569704-6970494.90295.37
668934-6893493.85494.32
30min169730-6973094.93894.450.5695.5695.070.56
269893-6989395.16095.79
368955-6895593.88394.50
469429-6942994.52895.15
568978-6897893.91494.54
669236-6923694.26594.89
极限169561-6956194.70894.490.6395.4995.270.63
269983-6998395.28296.07
368695-6869593.52994.31
469403-6940394.49395.27
569564-6956494.71295.50
669182-6918294.19294.97
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