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%
110.066595365900662146612465760659900.28
210.006611065431657700.74
单位质量响应值RSD%判断
6559.646577.000.19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%
5min170188-7018896.07795.391.0796.0895.391.07
270196-7019696.08796.09
369251-6925194.79494.79
470180-7018096.06696.07
568371-6837193.58993.59
669917-6991795.70695.71
10min170133-7013396.00197.060.9296.1697.220.92
271578-7157897.97998.14
370292-7029296.21996.38
471533-7153397.91898.08
570576-7057696.60896.76
671311-7131197.61497.77
15min170351-7035196.30096.700.6496.6297.020.63
270637-7063796.69197.01
370209-7020996.10596.42
470434-7043496.41396.74
570795-7079596.90797.22
671449-7144997.80398.12
20min171643-7164398.06896.831.1198.5597.311.10
270836-7083696.96497.45
370711-7071196.79297.27
471374-7137497.70098.18
569428-6942895.03695.51
670447-7044796.43196.92
30min171128-7112897.36396.420.9698.0197.060.95
270914-7091497.07097.72
370576-7057696.60897.25
469326-6932694.89795.54
570706-7070696.78697.42
669971-6997195.77996.43
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%
110.066558865756657686588165513657010.23
210.006587865484656810.43
单位质量响应值RSD%判断
6530.916568.100.41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%
5min168646-6864694.23695.321.0294.2495.321.02
268849-6884994.51594.51
370451-7045196.71496.71
469746-6974695.74695.75
569016-6901694.74494.74
669911-6991195.97395.97
10min170194-7019496.36197.551.1896.5297.711.18
270464-7046496.73296.89
371839-7183998.62098.78
471990-7199098.82798.99
571607-7160798.30198.46
670281-7028196.48196.64
15min170399-7039996.64398.030.8796.9698.350.87
271108-7110897.61697.93
371904-7190498.70999.03
472154-7215499.05299.38
571415-7141598.03898.36
671488-7148898.13898.46
20min170819-7081997.21997.160.7597.7097.640.75
269789-6978995.80596.29
370871-7087197.29197.78
471231-7123197.78598.27
570706-7070697.06497.55
671224-7122497.77598.26
30min170706-7070697.06497.560.5597.7098.200.55
270727-7072797.09397.73
370975-7097597.43398.09
471052-7105297.53998.19
571757-7175798.50799.15
671184-7118497.72098.37
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%
110.066592065974660406540365834658340.39
210.006578865917658520.14
单位质量响应值RSD%判断
6544.146585.200.45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%
5min171181-7118197.49195.621.4997.4995.621.48
269308-6930894.92594.93
368098-6809893.26893.27
470040-7004095.92895.93
570089-7008995.99596.00
670191-7019196.13596.13
10min172178-7217898.85698.320.8199.0298.480.81
271122-7112297.41097.57
371035-7103597.29197.45
471884-7188498.45498.61
572407-7240799.17099.33
672109-7210998.76298.92
15min171503-7150397.93298.490.5998.2698.810.59
271971-7197198.57398.89
371619-7161998.09198.41
471558-7155898.00798.33
572304-7230499.02999.35
672496-7249699.29299.62
20min171336-7133697.70398.060.3798.1998.540.37
271575-7157598.03098.52
371591-7159198.05298.53
471770-7177098.29798.78
571999-7199998.61199.10
671304-7130497.65998.15
30min171649-7164998.13297.830.3798.7998.480.37
270933-7093397.15197.80
371404-7140497.79698.44
471502-7150297.93098.58
571646-7164698.12898.78
671432-7143297.83598.49
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