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%
19.856549065459654236539765385654310.07
29.896530865325653160.02
单位质量响应值RSD%判断
6642.746604.250.42数据可信
供试品溶液-2025041121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%
5min171797-7179797.46195.342.1597.4695.342.15
272221-7222198.03798.04
369944-6994494.94694.95
469418-6941894.23294.23
569808-6980894.76194.76
668240-6824092.63392.63
10min172461-7246198.36296.452.0898.5296.612.08
272960-7296099.04099.20
371443-7144396.98097.14
469695-6969594.60894.76
570375-7037595.53195.69
669379-6937994.17994.33
15min171606-7160697.20296.561.6797.5396.881.67
272993-7299399.08599.41
371520-7152097.08597.40
470172-7017295.25595.57
570815-7081596.12896.45
669675-6967594.58094.89
20min172062-7206297.82196.361.8498.3196.841.84
272747-7274798.75199.24
371480-7148097.03197.51
470293-7029395.41995.89
569541-6954194.39994.88
669810-6981094.76495.23
30min171984-7198497.71596.331.8398.3796.971.84
272624-7262498.58499.24
371311-7131196.80197.44
469829-6982994.79095.42
570881-7088196.21896.85
669169-6916993.89494.52
极限172185-7218597.98896.091.8898.8096.901.88
272485-7248598.39599.22
370951-7095196.31397.12
469567-6956794.43495.22
570211-7021195.30896.10
669344-6934494.13194.91
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%
19.856525065084651496535165202652070.16
29.896502365035650290.02
单位质量响应值RSD%判断
6620.006575.230.48数据可信
供试品溶液-AGP01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%
5min171001-7100196.75996.730.8296.7696.730.82
271841-7184197.90497.90
370611-7061196.22796.23
470473-7047396.03996.04
570467-7046796.03196.03
671504-7150497.44497.44
10min172467-7246798.75798.250.6298.9298.410.62
272498-7249898.79998.96
371536-7153697.48897.65
472207-7220798.40298.56
571528-7152897.47797.64
672319-7231998.55598.72
15min172190-7219098.37998.210.4598.7198.530.46
272352-7235298.60098.93
372000-7200098.12098.44
471787-7178797.83098.15
571619-7161997.60197.92
672441-7244198.72199.05
20min171840-7184097.90298.060.9898.3998.550.97
273051-7305199.553100.04
371579-7157997.54798.03
471090-7109096.88097.37
571703-7170397.71598.20
672482-7248298.77799.27
30min171442-7144297.36097.740.5498.0198.390.54
271744-7174497.77198.43
371506-7150697.44798.10
471336-7133697.21597.86
571921-7192198.01398.66
672371-7237198.62699.28
极限171432-7143297.34697.470.4398.1698.280.44
271590-7159097.56298.38
371399-7139997.30198.11
471455-7145597.37898.19
571165-7116596.98297.79
672078-7207898.22799.05
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%
19.856520665276650416520765272652000.15
29.896485865091649740.26
单位质量响应值RSD%判断
6619.296569.670.54数据可信
供试品溶液-AGP01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%
5min171062-7106296.88896.031.2496.8996.041.24
271371-7137197.31097.31
370926-7092696.70396.70
469567-6956794.85094.85
569214-6921494.36994.37
670475-7047596.08896.09
10min171732-7173297.80296.861.3297.9697.021.31
272543-7254398.90899.07
370776-7077696.49896.66
470102-7010295.57995.74
570845-7084596.59296.75
670256-7025695.78995.95
15min172011-7201198.18297.121.1098.5197.441.10
272286-7228698.55798.88
370746-7074696.45796.78
470685-7068596.37496.69
570346-7034695.91296.23
671299-7129997.21197.53
20min171809-7180997.90797.061.1298.3997.541.12
272339-7233998.62999.12
371390-7139097.33597.82
470472-7047296.08496.56
570348-7034895.91596.39
670781-7078196.50596.99
30min171773-7177397.85896.410.9598.5197.060.95
270760-7076096.47797.13
370943-7094396.72697.37
469716-6971695.05395.69
570442-7044296.04396.68
670647-7064796.32296.97
极限171558-7155897.56596.110.8298.3896.910.82
270317-7031795.87396.69
370108-7010895.58896.39
470027-7002795.47796.27
570229-7022995.75396.55
670703-7070396.39997.20
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