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)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%
110.156635366373658746593765890660850.39
210.196629665997661460.32
单位质量响应值RSD%判断
6510.846491.270.22数据可信
供试品溶液-AFP05批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167273-6727393.03991.353.4793.0491.353.47
269090-6909095.55295.55
367380-6738093.18793.19
464077-6407788.61988.62
565507-6550790.59790.60
662978-6297887.09987.10
10min167950-6795093.97693.351.2294.4993.861.23
268398-6839894.59595.13
367773-6777393.73194.25
467743-6774393.68994.18
567020-6702092.68993.19
666093-6609391.40791.89
15min167777-6777793.73692.232.3994.7893.262.39
268128-6812894.22295.28
367177-6717792.90693.94
467705-6770593.63794.65
564712-6471289.49790.52
664626-6462689.37890.37
20min166342-6634291.75292.431.1593.3193.961.16
268236-6823694.37195.95
366973-6697392.62494.18
466709-6670992.25993.79
566694-6669492.23893.75
666023-6602391.31092.80
30min166740-6674092.30292.001.1794.3794.051.17
267417-6741793.23895.34
366609-6660992.12194.19
466974-6697492.62694.67
565158-6515890.11492.14
666223-6622391.58793.58
极限166834-6683492.43290.773.8695.0193.333.78
266249-6624991.62394.25
366759-6675992.32894.91
467889-6788993.89196.45
560760-6076084.03286.56
665284-6528490.28892.79
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)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%
110.156624666178661416617166316662100.11
210.196638766348663680.05
单位质量响应值RSD%判断
6523.156513.050.11数据可信
供试品溶液-AFP05批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166759-6675992.08793.791.2392.0993.791.23
267637-6763793.29893.30
368810-6881094.91694.92
469052-6905295.25095.25
567809-6780993.53593.54
667886-6788693.64193.64
10min169121-6912195.34594.801.2895.8695.321.27
268083-6808393.91394.43
368437-6843794.40194.93
467814-6781493.54294.07
568628-6862894.66595.18
670258-7025896.91397.43
15min167855-6785593.59993.471.0494.6494.511.03
267834-6783493.57094.61
366724-6672492.03893.09
467181-6718192.66993.72
568419-6841994.37695.42
668541-6854194.54595.60
20min168055-6805593.87492.074.2795.4493.644.20
268418-6841894.37595.94
361195-6119584.41285.97
468261-6826194.15995.72
566209-6620991.32892.90
668334-6833494.25995.84
30min166654-6665491.94292.881.8894.0294.961.86
267528-6752893.14795.23
365226-6522689.97292.00
468510-6851094.50296.59
567499-6749993.10795.18
668605-6860594.63396.74
极限166272-6627291.41592.690.9094.0195.290.89
267338-6733892.88595.49
366963-6696392.36894.90
467145-6714592.61995.23
567360-6736092.91695.51
668118-6811893.96196.59
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)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%
110.156622766016663246617966055661600.20
210.196586065713657860.16
单位质量响应值RSD%判断
6518.236455.940.68数据可信
供试品溶液-AFS03批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166633-6663392.35491.941.9092.3591.941.90
265701-6570191.06391.06
367163-6716393.08993.09
467709-6770993.84693.85
564162-6416288.93088.93
666641-6664192.36692.37
10min170051-7005197.09293.143.3797.6093.653.35
266836-6683692.63693.14
368789-6878995.34395.86
466985-6698592.84293.36
567189-6718993.12593.62
663366-6336687.82688.34
15min167340-6734093.33492.071.3994.3993.101.38
264910-6491089.96690.99
366800-6680092.58693.63
465970-6597091.43692.47
567272-6727293.24094.25
666283-6628391.86992.87
20min167940-6794094.16692.361.5695.7493.901.55
265418-6541890.67092.19
365915-6591591.35992.92
467809-6780993.98495.53
566625-6662592.34393.87
666131-6613191.65993.17
30min167516-6751693.57892.011.5995.6794.061.59
265173-6517390.33192.35
366636-6663692.35994.43
467433-6743393.46395.53
566455-6645592.10894.15
665107-6510790.23992.26
极限166698-6669892.44592.071.2695.0694.641.25
264906-6490689.96192.49
366504-6650492.17694.76
467373-6737393.38095.97
566256-6625691.83294.39
666845-6684592.64895.17
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)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%
110.156622665886660516624565862660540.28
210.196630966403663560.11
单位质量响应值RSD%判断
6507.786511.870.05数据可信
供试品溶液-AFS03批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169197-6919795.57194.031.3195.5794.031.31
267702-6770293.50693.51
368266-6826694.28594.29
468912-6891295.17795.18
567581-6758193.33993.34
666827-6682792.29892.30
10min167556-6755693.30493.670.5693.8494.190.56
267611-6761193.38093.90
368036-6803693.96794.49
468499-6849994.60795.14
567612-6761293.38293.90
667607-6760793.37593.89
15min169215-6921595.59692.831.8296.6593.871.80
266364-6636491.65892.70
367220-6722092.84093.89
467256-6725692.89093.94
565617-6561790.62691.66
667595-6759593.35894.39
20min166186-6618691.41292.131.6192.9993.691.58
265024-6502489.80791.35
367161-6716192.75994.32
467673-6767393.46695.04
567864-6786493.73095.27
666345-6634591.63293.18
30min167611-6761193.38091.301.5995.4793.371.57
265548-6554890.53192.58
366676-6667692.08994.17
466328-6632891.60893.70
564515-6451589.10491.17
665944-6594491.07893.14
极限166782-6678292.23591.061.4694.8493.641.44
264207-6420788.67991.23
366497-6649791.84294.43
466423-6642391.74094.34
565431-6543190.37092.93
666232-6623291.47694.04
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)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%
110.156602866042659096626565748659980.29
210.196609466125661100.04
单位质量响应值RSD%判断
6502.276487.730.16数据可信
供试品溶液-AGP01批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min164997-6499789.97593.832.1989.9893.832.19
268702-6870295.10495.10
367360-6736093.24693.25
469095-6909595.64895.65
568146-6814694.33494.33
668372-6837294.64794.65
10min170307-7030797.32695.441.2597.8395.961.23
269663-6966396.43496.96
368706-6870695.11095.63
468110-6811094.28494.82
568267-6826794.50295.03
668625-6862594.99795.52
15min168319-6831994.57494.710.8095.6195.760.79
268979-6897995.48796.55
369195-6919595.78696.83
467891-6789193.98195.04
567983-6798394.10995.16
668126-6812694.30795.36
20min167762-6776293.80394.000.4995.3795.580.48
267452-6745293.37494.97
367790-6779093.84295.42
468177-6817794.37795.95
568390-6839094.67296.24
667863-6786393.94395.52
30min168533-6853394.87093.810.8496.9695.900.82
267825-6782593.89096.00
367370-6737093.26095.36
466950-6695092.67994.78
567715-6771593.73895.84
668190-6819094.39596.49
极限168478-6847894.79493.521.2997.4196.141.25
266368-6636891.87394.51
368223-6822394.44197.06
466946-6694692.67395.29
568230-6823094.45197.07
667087-6708792.86895.49
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)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%
110.156589966020659116613065942659800.15
210.196685766343666000.55
单位质量响应值RSD%判断
6500.496535.820.39数据可信
供试品溶液-AGP01批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168373-6837394.31396.071.0694.3196.071.07
269754-6975496.21896.22
369509-6950995.88095.88
470564-7056497.33597.34
570119-7011996.72196.72
669568-6956895.96195.96
10min168264-6826494.16395.200.8594.6995.740.85
269630-6963096.04796.58
369359-6935995.67396.21
469605-6960596.01296.55
568583-6858394.60395.14
668674-6867494.72895.26
15min167273-6727392.79694.301.3293.8495.361.31
268654-6865494.70195.77
368470-6847094.44795.51
468047-6804793.86394.94
569904-6990496.42597.49
667820-6782093.55094.61
20min168835-6883594.95093.740.9096.5195.320.88
268128-6812893.97595.57
368241-6824194.13195.72
468000-6800093.79895.39
567332-6733292.87794.48
667194-6719492.68794.27
30min167558-6755893.18994.200.8295.2896.300.81
268387-6838794.33296.45
369065-6906595.26797.38
468729-6872994.80496.92
567887-6788793.64395.76
668109-6810993.94996.04
极限167467-6746793.06392.980.7295.6795.610.69
267113-6711392.57595.22
367426-6742693.00795.65
466650-6665091.93694.58
568004-6800493.80496.44
667781-6778193.49696.11
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