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%
110.176582265850662896596165900659640.29
210.126619266291662420.11
单位质量响应值RSD%判断
6486.146545.650.65数据可信
供试品溶液-2025082621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%
5min166312-6631291.50393.141.7491.5093.141.74
267572-6757293.24293.24
367212-6721292.74592.74
468777-6877794.90494.90
568929-6892995.11495.11
666207-6620791.35891.36
10min167760-6776093.50195.181.5393.6595.331.53
268777-6877794.90495.06
369645-6964596.10296.26
469838-6983896.36896.53
570098-7009896.72796.89
667732-6773293.46293.61
15min167788-6778893.54095.361.7493.8595.681.74
268955-6895595.15095.46
370007-7000796.60296.92
469667-6966796.13296.45
570583-7058397.39697.72
667656-6765693.35893.67
20min167465-6746593.09495.201.8493.5695.681.84
269143-6914395.40995.88
369825-6982596.35196.83
469745-6974596.24096.72
570376-7037697.11197.59
667413-6741393.02293.49
30min167315-6731592.88795.061.8993.5195.691.89
268652-6865294.73295.36
369806-6980696.32496.96
469560-6956095.98596.62
570518-7051897.30797.95
667489-6748993.12793.75
极限167462-6746293.09095.041.7493.8695.831.74
268840-6884094.99195.78
369641-6964196.09796.89
469419-6941995.79096.59
570393-7039397.13497.94
667490-6749093.12893.90
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%
110.176630566277660856617066120661910.15
210.126623766432663340.21
单位质量响应值RSD%判断
6508.466554.740.51数据可信
供试品溶液-2025082621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%
5min168401-6840194.15893.282.3394.1693.292.33
269877-6987796.19096.19
366039-6603990.90690.91
467602-6760293.05893.06
568787-6878794.68994.69
665894-6589490.70790.71
10min170175-7017596.60094.962.1596.7695.112.15
270831-7083197.50397.66
367926-6792693.50493.66
467468-6746892.87393.03
569872-6987296.18396.34
667612-6761293.07293.22
15min170447-7044796.97495.502.0797.2995.812.07
270921-7092197.62797.95
367659-6765993.13693.44
469223-6922395.28995.60
570317-7031796.79597.11
667669-6766993.15093.46
20min170402-7040296.91295.401.6097.3995.871.60
270416-7041696.93297.42
368175-6817593.84794.31
468920-6892094.87295.34
569941-6994196.27896.76
667961-6796193.55294.01
30min169940-6994096.27695.341.6996.9295.971.70
270693-7069397.31397.96
368036-6803693.65594.27
469234-6923495.30495.93
569931-6993196.26496.90
667722-6772293.22393.84
极限169871-6987196.18194.801.4396.9895.591.44
269658-6965895.88896.70
367942-6794293.52694.30
468319-6831994.04594.83
569704-6970495.95196.75
667701-6770193.19493.97
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%
110.176629466131663686611466397662610.20
210.126609565982660380.13
单位质量响应值RSD%判断
6515.346525.490.12数据可信
供试品溶液-2025082721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%
5min165577-6557790.42492.111.7490.4292.101.74
268369-6836994.27494.27
365589-6558990.44190.44
466279-6627991.39291.39
567265-6726592.75292.75
667706-6770693.36093.36
10min168420-6842094.34494.841.5194.5094.991.51
269973-6997396.48696.64
367251-6725192.73292.88
468145-6814593.96594.12
569729-6972996.14996.30
669160-6916095.36595.52
15min168886-6888694.98795.251.3295.2995.561.31
269983-6998396.50096.82
367780-6778093.46293.77
468320-6832094.20694.52
569961-6996196.46996.78
669528-6952895.87296.19
20min168529-6852994.49595.241.3994.9695.711.39
269667-6966796.06496.54
367900-6790093.62794.09
468281-6828194.15394.62
569771-6977196.20796.68
670260-7026096.88297.36
30min168116-6811693.92594.811.4994.5595.441.48
269874-6987496.34996.99
367422-6742292.96893.59
468079-6807993.87494.50
569758-6975896.18996.83
669285-6928595.53796.17
极限168201-6820194.04294.771.7494.8295.561.74
270046-7004696.58697.39
367198-6719892.65993.43
467763-6776393.43894.22
569988-6998896.50697.30
669190-6919095.40696.20
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%
110.176609866120662156619366075661400.10
210.126606566206661360.16
单位质量响应值RSD%判断
6503.446535.180.35数据可信
供试品溶液-2025082721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%
5min163918-6391888.15290.902.1788.1590.902.17
266117-6611791.18591.18
364520-6452088.98288.98
466445-6644591.63791.64
566764-6676492.07792.08
667707-6770793.37893.38
10min166029-6602991.06394.122.2791.2194.282.27
269398-6939895.71095.86
366876-6687692.23192.38
468096-6809693.91494.07
569085-6908595.27895.43
670007-7000796.55096.71
15min167370-6737092.91394.601.6393.2194.911.63
269075-6907595.26495.58
367434-6743493.00193.30
468420-6842094.36194.67
568952-6895295.09595.41
670312-7031296.97097.29
20min167166-6716692.63194.761.6093.0895.221.61
269289-6928995.55996.03
367665-6766593.32093.78
468764-6876494.83595.30
569264-6926495.52596.00
670094-7009496.67097.15
30min167037-6703792.45493.721.4693.0694.351.47
268961-6896195.10795.74
366895-6689592.25892.87
467320-6732092.84493.47
569093-6909395.28995.92
668446-6844694.39795.04
极限167254-6725492.75394.121.5593.5194.901.56
269006-6900695.16995.96
366743-6674392.04892.81
468242-6824294.11594.89
568745-6874594.80995.60
669475-6947595.81696.61
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%
110.176621966104661866604266112661330.11
210.126626566290662780.03
单位质量响应值RSD%判断
6502.756549.210.51数据可信
供试品溶液-2025082821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%
5min168111-6811193.83993.811.0293.8493.811.02
266914-6691492.19092.19
368699-6869994.64994.65
468132-6813293.86893.87
567842-6784293.46993.47
668847-6884794.85394.85
10min170206-7020696.72695.901.6096.8896.061.60
267467-6746792.95293.11
370446-7044697.05697.21
470070-7007096.53896.69
569326-6932695.51395.67
670120-7012096.60796.77
15min170078-7007896.54996.620.8296.8796.940.83
269191-6919195.32795.64
370743-7074397.46697.79
470461-7046197.07797.39
569787-6978796.14896.46
670534-7053497.17897.50
20min169987-6998796.42496.490.6596.9096.960.65
269172-6917295.30195.77
370478-7047897.10097.58
470115-7011596.60097.08
570184-7018496.69597.17
670269-7026996.81397.29
30min169648-6964895.95795.620.9196.6096.260.91
268719-6871994.67795.30
370095-7009596.57397.22
469887-6988796.28696.93
568548-6854894.44195.08
669524-6952495.78696.43
极限169530-6953095.79496.010.4396.5996.800.43
269338-6933895.53096.31
369844-6984496.22797.03
469724-6972496.06296.86
570166-7016696.67197.46
669500-6950095.75396.56
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%
110.176615266158663276622766162662050.12
210.126622266057661400.18
单位质量响应值RSD%判断
6509.836535.570.28数据可信
供试品溶液-2025082821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%
5min166245-6624591.31493.212.5691.3193.212.56
265519-6551990.31390.31
368794-6879494.82794.83
467760-6776093.40293.40
570259-7025996.84796.85
667159-6715992.57392.57
10min167848-6784893.52395.461.7793.6895.611.77
268288-6828894.13094.28
370472-7047297.14097.30
468806-6880694.84495.00
570953-7095397.80397.96
669139-6913995.30395.46
15min168626-6862694.59696.071.5794.9096.391.57
268903-6890394.97795.28
370845-7084597.65497.97
469519-6951995.82696.14
571242-7124298.20298.53
669057-6905795.19095.50
20min168719-6871994.72496.241.8395.1996.711.83
268854-6885494.91095.38
371003-7100397.87298.35
469355-6935595.60096.07
571799-7179998.96999.46
669175-6917595.35295.82
30min168570-6857094.51895.771.8095.1496.401.80
268283-6828394.12394.75
370388-7038897.02497.67
469160-6916095.33295.96
571546-7154698.62199.27
668908-6890894.98495.61
极限168250-6825094.07795.861.7294.8696.661.72
268731-6873194.74095.52
370701-7070197.45698.26
469002-6900295.11495.91
571300-7130098.28199.10
669275-6927595.49096.28
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