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%
110.066535265880657756564065774656840.32
210.006579065670657300.13
单位质量响应值RSD%判断
6529.226573.000.48数据可信
供试品溶液-AFS03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%
5min166881-6688191.79194.361.7691.7994.361.76
269834-6983495.84495.84
369877-6987795.90395.90
468730-6873094.32994.33
569404-6940495.25495.25
667806-6780693.06193.06
10min168047-6804793.39196.191.5893.5496.351.58
270859-7085997.25197.41
371234-7123497.76597.93
470127-7012796.24696.40
570101-7010196.21096.37
670165-7016596.29896.45
15min168613-6861394.16896.301.3094.4896.611.30
270875-7087597.27397.59
370474-7047496.72297.05
469761-6976195.74496.06
571133-7113397.62797.95
670120-7012096.23696.55
20min168403-6840393.88096.401.3694.3596.881.35
270739-7073997.08697.57
370877-7087797.27597.76
470090-7009096.19596.67
570880-7088097.28097.76
670437-7043796.67297.15
30min168733-6873394.33396.151.1394.9596.791.13
270221-7022196.37597.02
371054-7105497.51898.16
469798-6979895.79596.43
570555-7055596.83397.48
669984-6998496.05096.69
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%
110.066568865574656826566565599656420.08
210.006553665526655310.02
单位质量响应值RSD%判断
6525.056553.100.31数据可信
供试品溶液-AFS03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%
5min168893-6889394.72696.501.0694.7396.501.06
270598-7059897.07097.07
370731-7073197.25397.25
470003-7000396.25296.25
569980-6998096.22196.22
670903-7090397.49097.49
10min169474-6947495.52597.581.2495.6897.741.24
271815-7181598.74498.91
371881-7188198.83499.00
470847-7084797.41397.57
570935-7093597.53497.69
670850-7085097.41797.58
15min169966-6996696.20197.640.9096.5297.970.90
271773-7177398.68699.01
371560-7156098.39398.72
471031-7103197.66697.99
570802-7080297.35197.67
670961-7096197.56997.89
20min169953-6995396.18397.861.0496.6698.341.04
271964-7196498.94899.44
371901-7190198.86299.35
471187-7118797.88098.37
570921-7092197.51498.00
671094-7109497.75298.24
30min169817-6981795.99697.781.2496.6398.431.24
272163-7216399.22299.88
371889-7188998.84599.50
471418-7141898.19898.85
570783-7078397.32597.97
670609-7060997.08597.74
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%
110.066579065793655936570665445656650.23
210.006564565499655720.16
单位质量响应值RSD%判断
6527.346557.200.33数据可信
供试品溶液-AFS03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%
5min170700-7070097.16396.660.8297.1696.660.82
270436-7043696.80096.80
369920-6992096.09196.09
470029-7002996.24196.24
571241-7124197.90797.91
669696-6969695.78395.78
10min172186-7218699.20598.420.5199.3798.590.51
271226-7122697.88698.05
371441-7144198.18198.34
471502-7150298.26598.43
571918-7191898.83799.00
671434-7143498.17298.33
15min171548-7154898.32998.520.3098.6698.850.29
271665-7166598.48998.81
371810-7181098.68999.01
471372-7137298.08798.41
571961-7196198.89699.22
671777-7177798.64398.97
20min171863-7186398.76198.560.3299.2599.050.32
271325-7132598.02298.51
371792-7179298.66499.15
471567-7156798.35598.84
571850-7185098.74499.24
671902-7190298.81599.30
30min171741-7174198.59498.240.4899.2598.890.48
270919-7091997.46498.12
371445-7144598.18798.84
471285-7128597.96798.62
571818-7181898.70099.36
671685-7168598.51799.17
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