褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.986732067295672656721467290672770.06
29.966722067165671920.06
单位质量响应值RSD%判断
6741.186746.180.06数据可信
供试品溶液-2025082621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%
5min170858-7085894.47192.562.0294.4792.562.02
270835-7083594.44194.44
368560-6856091.40791.41
470314-7031493.74693.75
568164-6816490.88090.88
667818-6781890.41890.42
10min171799-7179995.72693.272.0596.7894.302.05
270130-7013093.50194.55
368623-6862391.49192.51
471496-7149695.32296.36
568523-6852391.35892.37
669166-6916692.21593.22
15min170197-7019793.59091.751.6595.7093.811.65
270089-7008993.44695.53
367479-6747989.96692.00
468647-6864791.52393.62
568698-6869891.59193.62
667789-6778990.38092.41
20min169438-6943892.57891.681.9895.7394.761.95
269024-6902492.02695.15
366825-6682589.09492.13
470551-7055194.06297.18
567519-6751990.02093.06
669208-6920892.27195.30
30min168619-6861991.48690.151.7395.6794.251.73
268835-6883591.77495.92
366058-6605888.07292.09
468464-6846491.27995.44
566989-6698989.31393.36
666737-6673788.97793.04
极限167822-6782290.42488.692.1795.6293.792.12
268632-6863291.50396.67
365478-6547887.29892.30
466161-6616188.20993.39
566205-6620588.26893.30
664823-6482386.42591.47
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.986739567252671306724267257672550.14
29.966718267157671700.03
单位质量响应值RSD%判断
6738.986743.980.06数据可信
供试品溶液-2025082621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%
5min167079-6707989.46292.442.2789.4692.442.28
268303-6830391.09591.09
369461-6946192.63992.64
469711-6971192.97292.97
571791-7179195.74795.75
669513-6951392.70892.71
10min167846-6784690.48592.921.8591.4893.951.86
269094-6909492.15093.16
369686-6968692.93993.97
470606-7060694.16695.20
571560-7156095.43896.50
669246-6924692.35293.38
15min166765-6676589.04391.772.1891.0493.832.18
267912-6791290.57392.61
368561-6856191.43993.50
469483-6948392.66894.75
571193-7119394.94997.07
668942-6894291.94794.00
20min165632-6563287.53290.362.6090.5293.442.58
266765-6676589.04392.09
366661-6666188.90591.98
469296-6929692.41995.53
570277-7027793.72796.91
667877-6787790.52693.60
30min165837-6583787.80689.872.7991.7793.952.76
265135-6513586.87090.90
367174-6717489.58993.65
468322-6832291.12095.26
570422-7042293.92198.14
667418-6741889.91494.00
极限164564-6456486.10888.962.2891.0494.042.28
265341-6534187.14492.14
366767-6676789.04694.11
467406-6740689.89895.05
568716-6871691.64596.91
667419-6741989.91695.00
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.986712167190672796749367351672870.22
29.966721667146671810.08
单位质量响应值RSD%判断
6742.186745.080.04数据可信
供试品溶液-2025082721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%
5min169531-6953192.70392.821.7092.7092.821.70
269000-6900091.99591.99
369368-6936892.48592.49
471558-7155895.40595.41
570177-7017793.56493.56
668057-6805790.73890.74
10min169301-6930192.39693.371.5393.4394.401.53
269856-6985693.13694.16
370218-7021893.61994.65
471684-7168495.57396.63
570537-7053794.04495.08
668584-6858491.44092.45
15min168733-6873391.63992.281.2693.7094.351.27
269462-6946292.61194.67
369240-6924092.31594.38
470490-7049093.98196.10
569484-6948492.64094.72
667877-6787790.49892.52
20min167994-6799490.65491.341.1693.7394.441.16
268607-6860791.47194.56
368407-6840791.20494.30
469398-6939892.52595.69
569315-6931592.41595.53
667333-6733389.77292.80
30min167726-6772690.29690.251.5794.3894.361.55
266635-6663588.84292.94
367744-6774490.32094.43
468807-6880791.73795.93
568893-6889391.85295.99
666345-6634588.45592.48
极限166836-6683689.11089.261.3794.2094.371.36
266635-6663588.84293.93
367372-6737289.82494.93
467301-6730189.73094.94
568137-6813790.84496.01
665417-6541787.21892.23
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.986715767407672506719167300672610.15
29.966720167162671820.05
单位质量响应值RSD%判断
6739.586745.180.06数据可信
供试品溶液-2025082721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%
5min168741-6874191.66791.520.7291.6791.530.72
267904-6790490.55090.55
369357-6935792.48892.49
468703-6870391.61691.62
568298-6829891.07691.08
668800-6880091.74591.75
10min167722-6772290.30891.801.1591.3392.811.14
268120-6812090.83891.84
369127-6912792.18193.21
468797-6879791.74192.76
569731-6973192.98794.00
669531-6953192.72093.74
15min167837-6783790.46191.031.0292.4893.071.01
267584-6758490.12492.14
368499-6849991.34493.40
468116-6811690.83392.87
569541-6954192.73394.78
668019-6801990.70492.75
20min166562-6656288.76189.421.0491.7992.461.01
266559-6655988.75791.77
367355-6735589.81892.89
467305-6730589.75292.80
566356-6635688.48691.56
668183-6818390.92293.98
30min165777-6577787.71488.641.0591.7392.691.03
265451-6545187.27991.28
366609-6660988.82392.89
466983-6698389.32293.37
567072-6707289.44193.50
666956-6695689.28693.35
极限165209-6520986.95788.071.2691.9493.091.23
265392-6539287.20192.17
366829-6682989.11794.17
465317-6531787.10192.14
567056-6705689.42094.47
666443-6644388.60293.66
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.986732767466668466729567349672570.36
29.966711967285672020.18
单位质量响应值RSD%判断
6739.186747.190.09数据可信
供试品溶液-2025082821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%
5min169938-6993893.25292.200.8893.2592.200.88
268467-6846791.29091.29
369567-6956792.75792.76
468523-6852391.36591.36
568904-6890491.87391.87
669506-6950692.67692.68
10min169087-6908792.11792.151.1493.1593.171.13
268250-6825091.00192.02
369159-6915992.21393.24
469055-6905592.07493.09
568578-6857891.43892.46
670536-7053694.04995.08
15min167973-6797390.63290.730.6492.6992.780.64
267516-6751690.02292.05
368592-6859291.45793.51
468294-6829491.06093.10
567588-6758890.11892.16
668330-6833091.10893.18
20min165836-6583687.78289.991.5290.8593.051.48
267359-6735989.81392.84
368127-6812790.83793.91
468585-6858591.44894.50
566860-6686089.14892.19
668188-6818890.91894.01
30min166224-6622488.30088.880.9192.3492.940.89
266637-6663788.85092.87
366609-6660988.81392.89
466626-6662688.83692.90
566077-6607788.10492.13
667788-6778890.38594.48
极限164454-6445485.94087.451.1490.9692.501.10
265882-6588287.84492.85
366152-6615288.20493.27
466127-6612788.17093.22
564849-6484986.46691.47
666074-6607488.10093.20
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.986733867339672416723867244672800.08
29.966690567159670320.27
单位质量响应值RSD%判断
6741.486730.120.12数据可信
供试品溶液-2025082821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%
5min170794-7079494.49692.461.3794.5092.461.37
269779-6977993.14293.14
368437-6843791.35091.35
468236-6823691.08291.08
569416-6941692.65792.66
668944-6894492.02792.03
10min169894-6989493.29591.930.8094.3592.960.81
268939-6893992.02093.06
368397-6839791.29792.31
468504-6850491.44092.45
568888-6888891.95292.98
668591-6859191.55692.58
15min167677-6767790.33690.790.7192.4292.840.68
267640-6764090.28692.34
367813-6781390.51792.55
468488-6848891.41893.45
567718-6771890.39192.44
668754-6875491.77393.81
20min166748-6674889.09689.531.0392.1992.591.00
267265-6726589.78692.85
366154-6615488.30391.34
466773-6677389.12992.17
567309-6730989.84592.90
668179-6817991.00694.07
30min167223-6722389.73088.830.6693.8192.880.64
266000-6600088.09792.16
366322-6632288.52792.54
466566-6656688.85392.89
566858-6685889.24393.30
666308-6630888.50892.58
极限166360-6636088.57888.020.5293.6693.060.52
265753-6575387.76892.80
365394-6539487.28892.29
466111-6611188.24693.27
565887-6588787.94792.99
666152-6615288.30093.35
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