褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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)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%
110.306685466390668286694566797667630.33
210.376702066840669300.20
单位质量响应值RSD%判断
6481.846454.190.31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%
5min170367-7036797.81697.920.9497.8297.920.94
271157-7115798.91498.91
369735-6973596.93796.94
471168-7116898.92998.93
569659-6965996.83196.83
670557-7055798.08098.08
10min171639-7163999.58498.950.88100.1399.500.87
271327-7132799.15099.70
370620-7062098.16798.71
472028-72028100.124100.67
571118-7111898.85999.40
670364-7036497.81198.36
15min171030-7103098.73798.470.4899.8399.560.48
270701-7070198.28099.38
371331-7133199.156100.24
470990-7099098.68299.79
570438-7043897.91499.00
670531-7053198.04399.13
20min170209-7020997.59697.240.4399.2498.880.42
269727-6972796.92698.57
370221-7022197.61399.25
469830-6983097.06998.72
569542-6954296.66998.30
670202-7020297.58699.22
30min170414-7041497.88196.490.85100.0798.670.83
269028-6902895.95498.14
368922-6892295.80797.98
469702-6970296.89199.08
569465-6946596.56298.73
668938-6893895.82998.00
极限169055-6905595.99296.501.1698.7299.221.13
269354-6935496.40799.13
368722-6872295.52998.24
470342-7034297.781100.51
570454-7045497.936100.64
668598-6859895.35698.06
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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)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%
110.306688166951670166691066900669320.09
210.376688066844668620.04
单位质量响应值RSD%判断
6498.256447.640.56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%
5min169670-6967096.77497.671.8396.7797.671.83
270571-7057198.02598.03
369760-6976096.89996.90
469051-6905195.91495.91
570124-7012497.40597.40
672719-72719101.009101.01
10min170293-7029397.63998.811.3698.1899.351.36
270944-7094498.54499.09
371132-7113298.80599.34
470177-7017797.47898.01
571442-7144299.23599.78
672825-72825101.156101.72
15min169934-6993497.14198.111.5198.2299.201.51
270758-7075898.28599.38
370703-7070398.20999.30
470030-7003097.27498.35
569746-6974696.88097.97
672633-72633100.890102.01
20min169845-6984597.01797.742.3398.6499.382.31
268990-6899095.82997.47
370234-7023497.55799.19
468644-6864495.34996.96
571459-7145999.259100.89
673009-73009101.412103.10
30min168674-6867495.39096.411.3797.5598.601.38
269711-6971196.83199.00
368951-6895195.77597.95
468732-6873295.47197.62
569209-6920996.13498.32
671192-7119298.888101.14
极限169505-6950596.54596.530.9299.2399.240.93
269045-6904595.90698.61
369888-6988897.07799.78
468782-6878295.54198.22
569209-6920996.13498.85
670524-7052497.960100.76
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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)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%
110.306708066988667546695866984669530.18
210.376679066803667960.02
单位质量响应值RSD%判断
6500.296441.270.65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%
5min170282-7028297.65796.330.8697.6696.340.86
269251-6925196.22596.22
369383-6938396.40896.41
469152-6915296.08796.09
568437-6843795.09495.09
669476-6947696.53796.54
10min171150-7115098.86397.800.9699.4198.340.96
270636-7063698.14998.68
370893-7089398.50699.04
469491-6949196.55897.09
569652-6965296.78297.31
670494-7049497.95298.49
15min169731-6973196.89297.230.4997.9898.300.49
269641-6964196.76797.85
369916-6991697.14998.23
470018-7001897.29098.36
569916-6991697.14998.21
670613-7061398.11799.20
20min169264-6926496.24396.400.9297.8798.020.90
269977-6997797.23398.85
369873-6987397.08998.71
468259-6825994.84696.46
569206-6920696.16297.77
669700-6970096.84998.47
30min169361-6936196.37795.220.6698.5497.380.65
268471-6847195.14197.30
368145-6814594.68896.85
468391-6839195.03097.17
568658-6865895.40197.54
668160-6816094.70996.87
极限169429-6942996.47295.850.9799.1798.530.96
268318-6831894.92897.61
369751-6975196.91999.61
468190-6819094.75097.42
568678-6867895.42898.10
669512-6951296.58799.28
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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)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%
110.306662766824667616681266925667900.17
210.376678866886668370.11
单位质量响应值RSD%判断
6484.476445.230.43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%
5min170683-7068398.30396.900.9998.3096.900.99
269325-6932596.41596.41
370125-7012597.52797.53
468749-6874995.61495.61
569314-6931496.39996.40
669829-6982997.11697.12
10min169836-6983697.12597.530.4997.6798.060.49
270313-7031397.78998.32
370239-7023997.68698.23
470564-7056498.13898.67
569621-6962196.82697.36
670173-7017397.59498.13
15min169630-6963096.83997.180.8197.9298.260.81
269286-6928696.36197.44
370598-7059898.18599.27
469730-6973096.97898.05
569464-6946496.60897.68
670557-7055798.12899.21
20min169190-6919096.22796.101.1097.8597.721.09
269128-6912896.14197.76
369565-6956596.74998.38
468028-6802894.61196.23
568498-6849895.26596.87
670172-7017297.59399.22
30min168798-6879895.68295.900.6497.8498.060.62
268874-6887495.78897.94
368631-6863195.45097.62
468462-6846295.21597.36
569408-6940896.53098.67
669561-6956196.74398.91
极限167784-6778494.27294.900.7296.9697.590.71
268386-6838695.10997.79
367798-6779894.29196.99
468034-6803494.61997.29
568327-6832795.02797.70
669084-6908496.08098.79
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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)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%
110.306688467019669076674567034669180.18
210.376674466649666960.11
单位质量响应值RSD%判断
6496.896431.630.72数据可信
供试品溶液-AGP01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%
5min170024-7002497.39796.810.8997.4096.810.89
269342-6934296.44996.45
369916-6991697.24797.25
468452-6845295.21195.21
569914-6991497.24497.24
669948-6994897.29297.29
10min170849-7084998.54598.060.8599.0998.600.85
269928-6992897.26497.80
370435-7043597.96998.51
469771-6977197.04597.57
571381-7138199.28599.83
670647-7064798.26498.80
15min170903-7090398.62098.440.8199.7199.520.81
270901-7090198.61799.69
371006-7100698.76399.85
469628-6962896.84797.91
571002-7100298.75899.85
671208-7120899.044100.13
20min170444-7044497.98298.250.9399.6299.880.91
270009-7000997.37699.00
370889-7088998.600100.23
471495-7149599.443101.05
571136-7113698.944100.58
669831-6983197.12998.77
30min169957-6995797.30497.220.5999.4899.400.59
269306-6930696.39998.56
369990-6999097.35099.53
469520-6952096.69698.85
570367-7036797.874100.06
670249-7024997.71099.89
极限169583-6958396.78497.010.8499.5199.720.83
269678-6967896.91699.62
369779-6977997.05799.78
468774-6877495.65998.35
570449-7044997.988100.72
670206-7020697.650100.37
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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)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%
110.306670666911670136667966769668160.22
210.376671366884667980.19
单位质量响应值RSD%判断
6486.996441.470.50数据可信
供试品溶液-AGP01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%
5min170237-7023797.69397.210.7197.6997.200.71
270324-7032497.81497.81
370443-7044397.97997.98
469466-6946696.62096.62
569442-6944296.58796.59
669411-6941196.54496.54
10min170670-7067098.29598.800.5898.8499.340.57
270950-7095098.68599.23
371800-7180099.867100.41
470871-7087198.57599.11
571103-7110398.89799.43
670782-7078298.45198.99
15min169301-6930196.39197.640.9897.4898.730.97
270012-7001297.38098.47
370792-7079298.46599.56
469803-6980397.08998.17
571180-7118099.004100.09
670110-7011097.51698.60
20min168627-6862795.45397.371.1297.0899.001.11
269983-6998397.34098.97
370574-7057498.16299.81
470666-7066698.29099.91
570517-7051798.08299.72
669655-6965596.88398.51
30min169076-6907696.07896.121.4998.2398.291.46
268933-6893395.87998.05
371057-7105798.833101.02
468242-6824294.91897.09
569026-6902696.00898.19
668300-6830094.99997.16
极限168063-6806394.66996.441.3497.3699.141.30
269778-6977897.05499.76
368537-6853795.32898.07
470493-7049398.049100.75
569116-6911696.13498.85
670016-7001697.385100.08
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