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%
110.076710066983670976710466906670380.14
210.116712067223671720.11
单位质量响应值RSD%判断
6657.206644.110.14数据可信
供试品溶液-AFP05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%
5min168467-6846792.56092.681.4792.5692.681.47
268059-6805992.00992.01
368027-6802791.96691.97
469609-6960994.10494.10
569881-6988194.47294.47
667271-6727190.94490.94
10min169489-6948993.94295.591.7294.1095.741.72
269493-6949393.94794.10
369935-6993594.54594.70
471312-7131296.40796.56
572184-7218497.58597.74
671831-7183197.10897.26
15min170505-7050595.31695.442.0795.6395.752.07
269790-6979094.34994.66
368159-6815992.14492.45
471268-7126896.34796.66
571941-7194197.25797.58
671915-7191597.22297.54
20min170462-7046295.25796.101.6195.7396.571.60
269756-6975694.30394.77
370042-7004294.69095.15
471798-7179897.06497.54
571976-7197697.30497.79
672472-7247297.97598.45
30min169969-6996994.59194.923.0595.2295.553.04
266205-6620589.50290.13
369995-6999594.62695.25
471462-7146296.60997.25
571833-7183397.11197.76
671803-7180397.07097.71
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%
110.076697066954669136698967160669970.15
210.116694567004669740.07
单位质量响应值RSD%判断
6653.136624.530.31数据可信
供试品溶液-AFP05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%
5min173291-7329199.25998.740.6899.2698.750.68
272764-7276498.54598.55
373038-7303898.91698.92
472897-7289798.72598.73
573439-7343999.45999.46
672036-7203697.55997.56
10min173157-7315799.07798.990.5299.2499.160.52
273163-7316399.08599.25
373004-7300498.87099.04
473247-7324799.19999.36
573561-7356199.62499.79
672425-7242598.08698.25
15min173139-7313999.05398.870.5699.3899.200.56
273110-7311099.01499.34
372875-7287598.69599.03
473091-7309198.98899.32
573518-7351899.56699.90
672287-7228797.89998.23
20min172492-7249298.17798.670.6098.6799.160.60
273024-7302498.89799.39
372969-7296998.82399.32
472765-7276598.54699.04
573555-7355599.616100.11
672337-7233797.96798.46
30min172945-7294598.79098.370.8999.4599.020.89
272729-7272998.49899.16
372792-7279298.58399.24
472784-7278498.57299.23
573181-7318199.11099.77
671357-7135796.64097.29
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%
110.076715867187670146718267139671360.11
210.116701867131670740.12
单位质量响应值RSD%判断
6666.936634.420.35数据可信
供试品溶液-AFP05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%
5min170577-7057795.41394.341.5595.4194.341.55
268595-6859592.73492.73
368458-6845892.54892.55
470968-7096895.94295.94
569580-6958094.06594.07
670534-7053495.35595.35
10min171935-7193597.24996.201.5697.4196.351.56
270338-7033895.09095.24
369265-6926593.63993.79
471888-7188897.18597.35
571623-7162396.82796.98
671886-7188697.18397.34
15min171678-7167896.90296.351.3597.2296.661.35
270618-7061895.46995.78
369669-6966994.18694.50
471921-7192197.23097.55
571458-7145896.60496.92
672261-7226197.69098.01
20min171563-7156396.74696.391.1197.2396.871.11
270503-7050395.31395.79
370175-7017594.87095.34
471823-7182397.09897.58
571566-7156696.75097.23
672181-7218197.58298.07
30min171744-7174496.99196.421.0697.6397.051.06
270345-7034595.09995.73
370492-7049295.29895.92
471698-7169896.92997.57
571379-7137996.49797.14
672253-7225397.67998.33
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