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%
19.926447664174646976470264470645040.34
29.976463864716646770.09
单位质量响应值RSD%判断
6502.426487.160.17数据可信
供试品溶液-2025040121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%
5min168731-6873195.14794.201.1195.1594.201.11
267804-6780493.86493.86
368888-6888895.36595.36
468327-6832794.58894.59
566874-6687492.57692.58
667674-6767493.68493.68
10min169163-6916395.74595.290.6896.2795.810.68
269410-6941096.08796.61
369173-6917395.75996.29
468446-6844694.75395.28
568428-6842894.72895.24
668383-6838394.66595.19
15min168717-6871795.12894.810.5896.1995.860.58
267972-6797294.09795.15
368977-6897795.48896.55
468764-6876495.19396.24
568116-6811694.29695.34
668370-6837094.64795.69
20min166980-6698092.72394.300.9094.3195.880.88
268260-6826094.49596.07
368498-6849894.82596.42
468650-6865095.03596.62
568402-6840294.69296.26
667937-6793794.04895.62
30min168616-6861694.98894.091.7197.0996.201.69
268415-6841594.71096.81
369151-6915195.72997.85
468094-6809494.26596.37
565809-6580991.10293.19
667733-6773393.76695.86
极限167806-6780693.86793.040.7496.5095.670.73
267394-6739493.29695.93
367643-6764393.64196.29
466847-6684792.53995.17
567051-6705192.82295.42
666509-6650992.07194.69
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%
19.926463364474644816459664751645870.18
29.976446664633645500.19
单位质量响应值RSD%判断
6510.796474.420.40数据可信
供试品溶液-AGP01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%
5min169583-6958396.36096.320.3696.3696.320.36
269800-6980096.66096.66
369433-6943396.15296.15
469885-6988596.77896.78
569364-6936496.05696.06
669278-6927895.93795.94
10min170609-7060997.78196.891.0898.3297.431.08
269257-6925795.90896.45
370468-7046897.58598.12
470818-7081898.07098.61
569085-6908595.67096.20
669557-6955796.32496.86
15min172550-72550100.46896.941.87101.5598.011.85
269237-6923795.88196.95
370036-7003696.98798.06
468954-6895495.48996.57
569480-6948096.21797.28
669740-6974096.57797.65
20min170110-7011097.09096.230.7698.7397.840.76
268859-6885995.35796.96
369824-6982496.69398.31
469896-6989696.79398.41
568958-6895895.49497.09
669296-6929695.96297.57
30min169797-6979796.65695.840.8198.8397.980.81
268452-6845294.79496.93
369730-6973096.56398.72
469419-6941996.13398.28
568646-6864695.06297.19
669193-6919395.82097.96
极限168882-6888295.38994.511.0398.1097.191.02
267484-6748493.45396.11
369068-6906895.64798.34
467694-6769493.74496.43
567703-6770393.75696.41
668667-6866795.09197.76
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%
19.926451464629646316457964413645530.15
29.976454064531645360.01
单位质量响应值RSD%判断
6507.366473.020.38数据可信
供试品溶液-2025040121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%
5min166342-6634291.90692.480.9891.9192.480.98
267101-6710192.95792.96
367753-6775393.86093.86
467036-6703692.86792.87
566051-6605191.50391.50
666250-6625091.77891.78
10min167727-6772793.82493.501.1894.3394.021.18
266677-6667792.37092.89
368964-6896495.53896.06
467311-6731193.24893.76
567166-6716693.04793.56
667120-6712092.98393.49
15min166848-6684892.60793.471.0693.6494.511.06
267023-6702392.84993.88
368622-6862295.06496.12
468053-6805394.27695.31
566963-6696392.76693.79
667334-6733493.28094.31
20min166669-6666992.35991.520.6793.9093.070.65
265514-6551490.75992.30
365850-6585091.22492.80
466028-6602891.47193.03
565819-6581991.18192.72
666488-6648892.10893.65
30min165601-6560190.87991.191.3592.9493.251.33
266278-6627891.81793.87
366870-6687092.63794.72
466565-6656592.21594.28
564733-6473389.67791.72
664916-6491689.93091.99
极限166682-6668292.37791.331.2394.9493.901.21
265057-6505790.12692.69
366223-6622391.74194.34
466897-6689792.67595.25
564994-6499490.03892.58
665721-6572191.04593.60
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%
19.926462264727646866472764520646560.14
29.976461464457645360.18
单位质量响应值RSD%判断
6517.746473.020.49数据可信
供试品溶液-2025040121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%
5min167797-6779793.84791.852.0093.8591.852.00
264071-6407188.68988.69
366008-6600891.37091.37
467367-6736793.25193.25
566851-6685192.53792.54
666033-6603391.40591.40
10min168423-6842394.71394.480.8495.2394.990.83
268349-6834994.61195.10
368037-6803794.17994.69
469149-6914995.71896.24
567403-6740393.30193.82
668166-6816694.35794.87
15min168076-6807694.23393.840.9595.2894.880.94
268022-6802294.15895.18
367531-6753193.47894.51
468666-6866695.05096.10
567706-6770693.72194.75
666759-6675992.41093.44
20min167926-6792694.02593.130.8995.6094.690.89
267559-6755993.51795.06
367400-6740093.29794.85
467676-6767693.67995.26
566715-6671592.34993.90
666394-6639491.90593.45
30min167435-6743593.34693.091.1795.4495.161.15
267893-6789393.98096.04
368164-6816494.35596.42
467309-6730993.17195.27
566638-6663892.24294.31
666060-6606091.44293.50
极限167687-6768793.69492.380.9396.3194.970.92
266729-6672992.36894.95
367224-6722493.05495.65
466508-6650892.06294.68
566152-6615291.57094.15
666121-6612191.52794.09
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%
19.926476564501645166472864508646040.21
29.976458764426645060.18
单位质量响应值RSD%判断
6512.506470.010.47数据可信
供试品溶液-2025040121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168010-6801094.20192.701.7594.2092.701.75
268006-6800694.19694.20
365226-6522690.34590.35
467691-6769193.75993.76
565977-6597791.38591.39
666632-6663292.29392.29
10min169292-6929295.97795.401.7996.5095.921.78
270110-7011097.11097.63
367928-6792894.08894.59
468550-6855094.94995.47
567151-6715193.01193.52
670240-7024097.29097.80
15min169626-6962696.44094.851.8597.5095.901.85
269191-6919195.83796.90
367380-6738093.32994.35
468997-6899795.56896.62
566450-6645092.04093.06
669247-6924795.91596.97
20min168799-6879995.29493.991.3996.8995.571.39
267944-6794494.11095.71
366394-6639491.96393.51
467589-6758993.61895.20
567489-6748993.48095.02
668946-6894695.49897.08
30min166720-6672092.41493.251.3194.5495.351.30
268630-6863095.06097.18
367014-6701492.82294.88
467812-6781293.92796.03
566156-6615691.63393.69
667624-6762493.66795.78
极限167627-6762793.67192.671.9696.3195.291.95
268059-6805994.26996.92
365076-6507690.13792.71
466520-6652092.13794.76
565818-6581891.16593.73
668340-6834094.65897.30
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