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%
19.996508865042649456497365033650160.09
29.896517264908650400.29
单位质量响应值RSD%判断
6508.116576.340.74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%
5min169113-6911394.98593.441.6694.9893.441.65
269360-6936095.32495.32
366772-6677291.76791.77
466843-6684391.86591.87
568329-6832993.90793.91
667500-6750092.76892.77
10min170725-7072597.20096.081.6597.3696.241.65
271831-7183198.72098.88
368755-6875594.49394.65
469412-6941295.39695.55
569546-6954695.58095.74
669184-6918495.08295.24
15min170895-7089597.43496.651.2897.7596.961.28
271881-7188198.78999.11
369839-6983995.98396.29
469825-6982595.96396.28
570001-7000196.20596.52
669494-6949495.50895.82
20min171017-7101797.60296.521.4398.0896.991.43
271668-7166898.49698.98
369358-6935895.32295.79
469931-6993196.10996.58
570374-7037496.71897.19
669011-6901194.84595.32
30min170772-7077297.26596.071.4797.9196.711.47
271491-7149198.25398.91
369634-6963495.70196.33
469095-6909594.96095.59
569616-6961695.67696.31
668828-6882894.59395.22
极限170763-7076397.25296.081.6898.0696.881.68
271833-7183398.72399.54
369698-6969895.78996.58
469268-6926895.19895.99
569253-6925395.17795.97
668666-6866694.37095.16
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%
19.996488164867649696495864703648760.17
29.896493765008649720.08
单位质量响应值RSD%判断
6494.096569.460.82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%
5min166047-6604790.91789.572.0190.9289.572.01
265763-6576390.52690.53
366307-6630791.27591.27
465436-6543690.07690.08
563596-6359687.54387.54
663276-6327687.10287.10
10min169461-6946195.61693.671.4195.7793.821.41
268154-6815493.81793.97
368021-6802193.63493.79
468639-6863994.48594.63
566941-6694192.14792.29
667059-6705992.31092.46
15min170013-7001396.37693.891.4296.6994.191.42
267923-6792393.49993.81
367834-6783493.37793.68
468411-6841194.17194.48
567813-6781393.34893.65
667228-6722892.54292.84
20min170348-7034896.83794.571.4297.3195.031.42
269035-6903595.03095.49
368287-6828794.00094.46
468862-6886294.79295.26
568152-6815293.81494.27
667507-6750792.92793.38
30min170327-7032796.80894.221.8097.4494.841.80
268723-6872394.60095.22
367426-6742692.81593.44
469049-6904995.04995.67
568296-6829694.01394.62
666855-6685592.02992.64
极限169727-6972795.98294.581.4396.7895.351.42
268360-6836094.10194.88
368145-6814593.80594.58
468917-6891794.86795.65
569807-6980796.09396.86
667279-6727992.61393.37
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%
19.996528264955651796484965004650540.27
29.896541564933651740.53
单位质量响应值RSD%判断
6511.916589.890.85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%
5min166978-6697891.92991.821.5891.9391.821.58
268811-6881194.44594.45
366598-6659891.40891.41
465969-6596990.54590.54
565960-6596090.53290.53
667072-6707292.05892.06
10min168981-6898194.67994.541.3694.8394.701.35
270167-7016796.30696.46
369376-6937695.22195.37
467573-6757392.74692.90
568074-6807493.43493.58
669126-6912694.87895.03
15min168859-6885994.51194.681.3194.8294.991.31
270594-7059496.89397.21
368849-6884994.49794.81
467996-6799693.32793.63
568355-6835593.81994.13
669235-6923595.02795.34
20min169503-6950395.39594.781.3795.8695.251.37
270673-7067397.00197.48
368614-6861494.17594.64
468090-6809093.45693.92
568364-6836493.83294.29
669091-6909194.83095.30
30min168968-6896894.66194.300.6395.2994.930.64
269133-6913394.88795.53
369118-6911894.86795.49
468087-6808793.45294.07
568380-6838093.85494.47
668563-6856394.10594.73
极限169281-6928195.09094.461.1195.8895.251.11
269890-6989095.92696.73
368524-6852494.05194.83
467748-6774892.98693.76
568366-6836693.83594.61
669142-6914294.90095.68
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