褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)4供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.676225362354623816223762074622600.20
29.646247362106622900.42
单位质量响应值RSD%判断
6438.476461.620.26数据可信
加速1月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121169910701157001297.5994.952.0992.87%~97.03%
265922661256602492.03
369221693216927196.56
467243672076722593.71
567894681356801494.81
668061682126813694.98
2024030221167440675706750594.1094.411.5892.85%~95.96%
267003672756713993.59
369520690366927896.57
466579664496651492.72
567315669876715193.61
668681688396876095.85
2024030321168920685336872695.8095.230.4594.79%~95.67%
268923683396863195.67
368180681546816795.02
468361682986833095.25
568050680096803094.83
667936681196802894.83
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)4供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.676244462140624676245262215623440.25
29.646230162405623530.12
单位质量响应值RSD%判断
6447.166468.150.23数据可信
加速1月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121169189687296895996.0197.841.4496.37%~99.31%
270656704757056698.25
369864699006988297.30
470100702247016297.69
5721397190172020100.27
670049700657005797.54
2024030221169797696326971497.0697.011.3195.68%~98.34%
270797712097100398.86
369122689826905296.14
468750687006872595.69
569204688986905196.14
670395706357051598.18
2024030321168940689626895196.0096.461.6194.83%~98.09%
269161691046913296.25
368316682306827395.06
471513710947130499.28
568584681676837695.20
669796695256966096.99
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)4供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.676231261817621376258862439622590.48
29.646209162056620740.04
单位质量响应值RSD%判断
6438.376439.210.01数据可信
加速1月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121170245706647045498.3895.402.1793.23%~97.56%
266191663716628192.55
369397695636948097.02
467418674866745294.19
567876683016808895.08
668298680186815895.17
2024030221168029682006811495.1195.341.4793.87%~96.81%
267846674026762494.43
369868698026983597.52
467404671346726993.93
567693676716768294.51
668980693196915096.56
2024030321169577692956943696.9696.130.6595.48%~96.78%
269296694476937296.87
368767683736857095.75
468369687706857095.75
568558688586870895.94
668621681936840795.52
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)4供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.676279362601625366256262684626350.17
29.646223461935620840.35
单位质量响应值RSD%判断
6477.256440.250.41数据可信
加速1月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121170324705027041398.0299.451.4297.97%~100.93%
2721997293072564101.01
370915704837069998.42
470786707407076398.51
5729267263672781101.32
671477713277140299.40
2024030221170540701877036497.9598.040.7997.23%~98.85%
271274709307110298.98
369609695626958696.87
470982704827073298.46
569960700617001097.46
670772707507076198.50
2024030321170752705877067098.3897.791.4596.30%~99.28%
269046692306913896.25
368922689596894095.97
471679715437161199.69
570726705437063498.33
670357706107048498.12
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