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%
110.066545565898655956567465511656270.27
210.006433664434643850.11
单位质量响应值RSD%判断
6523.566438.500.93数据可信
供试品溶液-25020701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%
5min166153-6615391.77799.473.9791.7899.473.97
273510-73510101.983101.98
373466-73466101.922101.92
471216-7121698.80198.80
573100-73100101.415101.41
672740-72740100.915100.92
10min169269-6926996.100100.562.4396.25100.722.44
273639-73639102.162102.33
373551-73551102.040102.21
473056-73056101.353101.52
571630-7163099.37599.54
673761-73761102.332102.50
15min173582-73582102.083102.180.47102.40102.510.48
273845-73845102.448102.79
373694-73694102.239102.58
473318-73318101.717102.05
573265-73265101.643101.98
674193-74193102.931103.27
20min173439-73439101.885101.540.73102.37102.040.73
272339-72339100.359100.87
373462-73462101.917102.43
473168-73168101.509102.01
572859-72859101.080101.58
673858-73858102.466102.98
30min173035-73035101.324101.780.52101.98102.450.52
273562-73562102.055102.73
373418-73418101.856102.54
472882-72882101.112101.78
573333-73333101.738102.41
673931-73931102.567103.25
45min173002-73002101.279101.120.83102.10101.960.82
271882-7188299.725100.57
373464-73464101.919102.77
472966-72966101.229102.07
572551-72551100.653101.49
673459-73459101.913102.76
60min172792-72792100.987100.870.71101.98101.880.71
272128-72128100.066101.08
373343-73343101.752102.77
472435-72435100.492101.50
572281-72281100.278101.29
673280-73280101.664102.69
极限172347-72347100.370100.660.54101.53101.840.54
272999-72999101.274102.46
372093-72093100.017101.21
472297-72297100.300101.48
572547-72547100.647101.82
673047-73047101.341102.53
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%
110.066473165007651406499765108649970.25
210.006528465537654100.28
单位质量响应值RSD%判断
6460.936541.000.88数据可信
供试品溶液-25020701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%
5min174932-74932103.637101.264.45103.64101.264.45
274778-74778103.424103.42
366881-6688192.50292.50
475220-75220104.035104.04
574955-74955103.669103.67
672526-72526100.309100.31
10min174780-74780103.427103.551.24103.60103.721.24
274664-74664103.266103.44
373488-73488101.640101.79
475244-75244104.068104.24
574716-74716103.338103.51
676342-76342105.587105.75
15min174222-74222102.655103.130.61103.00103.460.62
274630-74630103.219103.56
373870-73870102.168102.49
475125-75125103.904104.25
574643-74643103.237103.58
674882-74882103.568103.91
20min174446-74446102.965103.351.01103.48103.871.02
274442-74442102.959103.48
373768-73768102.027102.52
475049-75049103.799104.32
574643-74643103.237103.75
676012-76012105.130105.65
30min174199-74199102.623103.131.08103.31103.821.08
274424-74424102.934103.62
373687-73687101.915102.58
474854-74854103.529104.22
574230-74230102.666103.35
676019-76019105.140105.83
45min174155-74155102.562102.831.06103.42103.691.06
274218-74218102.649103.51
373253-73253101.315102.15
474601-74601103.179104.04
574203-74203102.628103.49
675677-75677104.667105.53
60min173941-73941102.266102.590.88103.30103.620.88
273775-73775102.037103.07
373543-73543101.716102.72
474538-74538103.092104.13
573935-73935102.258103.29
675318-75318104.171105.21
极限173790-73790102.057102.511.17103.26103.711.17
273654-73654101.869103.07
373348-73348101.446102.62
473991-73991102.335103.54
574114-74114102.505103.71
675799-75799104.836106.05
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%
110.066540765430653516538665559654270.13
210.006391063777638440.15
单位质量响应值RSD%判断
6503.686384.401.31数据可信
供试品溶液-25020701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%
5min173617-73617102.722100.264.12102.72100.264.12
272201-72201100.747100.75
365943-6594392.01492.01
473275-73275102.245102.25
573584-73584102.676102.68
672511-72511101.179101.18
10min174840-74840104.429103.420.83104.60103.590.83
273869-73869103.074103.24
374474-74474103.918104.07
473754-73754102.914103.08
574565-74565104.045104.22
673200-73200102.141102.31
15min174912-74912104.529103.530.93104.87103.870.93
273703-73703102.842103.18
374704-74704104.239104.57
474064-74064103.346103.69
574648-74648104.161104.51
673136-73136102.051102.39
20min174790-74790104.359103.400.85104.88103.910.85
273826-73826103.014103.53
374685-74685104.213104.71
474067-74067103.350103.86
574193-74193103.526104.04
673065-73065101.952102.46
30min174967-74967104.606103.140.95105.30103.820.95
273635-73635102.748103.43
374325-74325103.710104.38
473556-73556102.637103.32
574060-74060103.341104.03
672946-72946101.786102.46
45min174510-74510103.968103.160.68104.84104.020.68
273909-73909103.130103.98
374428-74428103.854104.70
473811-73811102.993103.85
573787-73787102.960103.82
673146-73146102.065102.91
60min174707-74707104.243103.080.86105.28104.100.86
273666-73666102.791103.82
374226-74226103.572104.59
473509-73509102.572103.60
574197-74197103.532104.57
672916-72916101.744102.76
极限174626-74626104.130102.910.88105.35104.110.87
273295-73295102.273103.47
374309-74309103.688104.88
473788-73788102.961104.16
573595-73595102.692103.90
672876-72876101.688102.88
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