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%
19.986422264203643116431864230642570.09
2 10.056407964337642080.29
单位质量响应值RSD%判断
6438.586388.860.55数据可信
供试品溶液-25070301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%
5min168601-6860196.16997.811.2696.1797.821.26
269998-6999898.12798.13
369728-6972897.74997.75
471284-7128499.93099.93
569603-6960397.57497.57
669434-6943497.33797.34
10min170359-7035998.63399.831.2198.7999.991.21
271173-7117399.77599.94
371567-71567100.327100.49
472674-72674101.879102.05
571124-7112499.70699.87
670375-7037598.65698.82
15min170337-7033798.60399.611.3798.9399.941.37
270611-7061198.98799.32
371434-71434100.140100.47
472771-72771102.015102.35
571049-7104999.60199.93
670112-7011298.28798.61
20min170067-7006798.22499.151.4498.7199.651.44
270519-7051998.85899.35
371346-71346100.017100.51
472425-72425101.530102.04
570431-7043198.73499.23
669592-6959297.55898.05
30min170643-7064399.03299.581.0899.68100.241.08
270831-7083199.29599.95
371484-71484100.211100.87
472250-72250101.284101.96
570999-7099999.531100.19
670009-7000998.14398.80
45min170689-7068999.09699.221.1999.91100.041.19
270405-7040598.69899.52
371137-7113799.724100.55
472051-72051101.005101.85
570858-7085899.333100.16
669508-6950897.44198.26
60min169846-6984697.91498.751.5098.9099.741.49
269710-6971097.72498.71
371254-7125499.888100.89
471980-71980100.906101.92
570656-7065699.050100.04
669198-6919897.00697.98
极限170157-7015798.35098.641.5399.5099.791.53
270079-7007998.24199.39
370923-7092399.424100.59
471867-71867100.748101.93
570525-7052598.866100.02
668617-6861796.19197.33
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%
19.986416064158640416410963999640930.12
2 10.056433763981641590.40
单位质量响应值RSD%判断
6422.146383.980.43数据可信
供试品溶液-25070301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%
5min171540-71540100.455100.960.84100.46100.960.84
271798-71798100.818100.82
371325-71325100.153100.15
471885-71885100.940100.94
573046-73046102.570102.57
671810-71810100.834100.83
10min171691-71691100.667101.501.16100.83101.671.16
272418-72418101.688101.86
371059-7105999.78099.95
472380-72380101.635101.80
573488-73488103.191103.36
672670-72670102.042102.21
15min172421-72421101.692101.820.86102.03102.160.86
272292-72292101.511101.85
371893-71893100.951101.28
472053-72053101.176101.51
573592-73592103.337103.68
672823-72823102.257102.60
20min172119-72119101.268101.740.97101.77102.240.97
272546-72546101.868102.37
371319-71319100.145100.65
472548-72548101.871102.38
573426-73426103.104103.62
672750-72750102.154102.66
30min170963-7096399.645101.331.48100.32102.001.48
272753-72753102.159102.84
370699-7069999.27499.94
472710-72710102.098102.77
573305-73305102.934103.62
672530-72530101.845102.52
45min172299-72299101.521101.850.80102.36102.700.80
272015-72015101.122101.97
372164-72164101.332102.17
472573-72573101.906102.75
573621-73621103.377104.24
672543-72543101.864102.71
60min172212-72212101.399101.430.36102.41102.450.36
271984-71984101.079102.09
371960-71960101.045102.05
472354-72354101.598102.61
572252-72252101.455102.49
672656-72656102.022103.04
极限171862-71862100.907101.451.08102.09102.641.07
272460-72460101.747102.93
371301-71301100.120101.29
471842-71842100.879102.06
573547-73547103.274104.47
672488-72488101.787102.97
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%
19.986412264146642266401364327641670.19
2 10.056427864210642440.08
单位质量响应值RSD%判断
6429.566392.440.41数据可信
供试品溶液-25070301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%
5min171038-7103899.62799.291.2199.6399.291.21
269810-6981097.90597.90
369990-6999098.15798.16
472054-72054101.052101.05
571334-71334100.042100.04
670555-7055598.95098.95
10min172803-72803102.102101.061.33102.27101.231.33
271315-71315100.015100.18
371266-7126699.947100.11
473327-73327102.837103.01
572572-72572101.778101.95
671089-7108999.69899.86
15min172680-72680101.930101.151.48102.27101.491.48
271459-71459100.217100.55
371082-7108299.689100.02
473588-73588103.203103.54
572876-72876102.205102.54
671075-7107599.679100.01
20min172817-72817102.122101.311.31102.63101.811.31
271665-71665100.506101.00
371346-71346100.059100.56
473437-73437102.991103.50
572945-72945102.301102.81
671212-7121299.871100.37
30min172489-72489101.662101.021.45102.34101.701.45
271488-71488100.258100.92
371036-7103699.624100.29
473539-73539103.134103.82
572719-72719101.984102.66
670934-7093499.481100.14
45min172843-72843102.158100.941.58103.00101.781.57
271510-71510100.289101.12
370922-7092299.464100.29
473411-73411102.955103.81
572553-72553101.752102.60
670592-7059299.00199.83
60min172590-72590101.804100.811.61102.82101.821.61
271361-71361100.080101.08
370634-7063499.060100.06
473639-73639103.275104.30
572238-72238101.310102.33
670810-7081099.307100.30
极限172438-72438101.590100.771.40102.78101.951.40
271340-71340100.050101.22
370921-7092199.463100.62
473393-73393102.930104.13
572200-72200101.257102.44
670831-7083199.337100.50
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