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)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%
110.306580266443667046652566449663850.52
210.376657466506665400.08
单位质量响应值RSD%判断
6445.156416.590.32数据可信
供试品溶液-2025082221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%
5min167281-6728194.06698.082.5694.0798.082.56
271379-7137999.79699.80
369027-6902796.50796.51
470246-7024698.21198.21
572353-72353101.157101.16
670636-7063698.75798.76
10min170594-7059498.698100.531.8299.74101.621.83
273611-73611102.916104.02
370507-7050798.57699.65
471865-71865100.475101.57
573272-73272102.442103.57
671590-71590100.091101.19
15min170420-7042098.45599.781.60100.60101.991.61
272901-72901101.923104.18
369848-6984897.65599.82
471321-7132199.714101.92
572309-72309101.096103.36
671408-7140899.836102.05
20min168820-6882096.21898.301.9699.45101.621.94
271293-7129399.675103.06
369811-6981197.603100.86
468936-6893696.38099.70
572297-72297101.079104.46
670708-7070898.857102.18
30min167809-6780994.80496.331.0999.11100.741.13
269723-6972397.480101.97
368385-6838595.61099.95
468723-6872396.082100.47
569679-6967997.419101.93
669102-6910296.612101.03
极限167124-6712493.84795.831.9799.20101.311.95
269253-6925396.823102.40
366821-6682193.42398.82
468968-6896896.425101.88
570374-7037498.390103.98
668723-6872396.082101.57
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)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%
110.306657366506663786662366510665180.14
210.376629466232662630.07
单位质量响应值RSD%判断
6458.066389.870.76数据可信
供试品溶液-2025082221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%
5min172301-72301101.19699.550.92101.2099.560.92
270808-7080899.10699.11
371269-7126999.75199.75
471083-7108399.49199.49
570932-7093299.27999.28
670372-7037298.49698.50
10min173054-73054102.249101.030.64103.37102.140.64
271962-71962100.721101.82
371971-71971100.734101.84
471818-71818100.519101.62
571977-71977100.742101.85
672316-72316101.217102.31
15min173320-73320102.622100.311.17104.88102.541.16
271536-71536100.125102.35
371574-71574100.178102.41
471337-7133799.846102.07
571141-7114199.572101.79
671097-7109799.510101.73
20min170930-7093099.27798.450.62102.68101.790.62
270102-7010298.118101.45
370298-7029898.392101.73
470047-7004798.041101.37
570797-7079799.090102.42
669853-6985397.769101.09
30min170418-7041898.56097.341.03103.06101.781.00
269684-6968497.533101.96
369062-6906296.662101.10
470312-7031298.412102.83
569131-6913196.759101.19
668674-6867496.119100.53
极限169291-6929196.98396.840.81102.58102.360.77
268861-6886196.381101.89
369109-6910996.728102.24
469346-6934697.060102.57
568419-6841995.762101.27
670096-7009698.109103.59
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)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%
110.306649866532665156651866522665170.02
210.376649066445664680.05
单位质量响应值RSD%判断
6457.966409.640.54数据可信
供试品溶液-2025082321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%
5min170931-7093199.12597.971.3699.1297.961.36
268704-6870496.01396.01
369607-6960797.27597.27
470450-7045098.45398.45
569678-6967897.37497.37
671245-7124599.56499.56
10min171732-71732100.24498.981.24101.35100.071.24
269356-6935696.92497.99
370453-7045398.45799.54
471674-71674100.163101.26
570813-7081398.960100.04
670920-7092099.109100.22
15min171568-71568100.01598.601.06102.23100.781.05
269370-6937096.94399.09
370389-7038998.367100.54
470315-7031598.264100.47
571036-7103699.272101.45
670636-7063698.713100.92
20min169381-6938196.95996.241.52100.2999.521.50
267845-6784594.81298.03
367488-6748894.31397.58
469853-6985397.618100.92
568665-6866595.95899.24
669971-6997197.783101.09
30min168801-6880196.14895.430.64100.5599.780.66
267512-6751294.34798.62
368281-6828195.42299.74
468179-6817995.27999.66
568485-6848595.707100.06
668461-6846195.673100.06
极限168698-6869896.00494.191.76101.4899.601.72
265501-6550191.53796.86
366652-6665293.14598.52
467601-6760194.47199.91
567522-6752294.36199.77
668438-6843895.641101.09
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)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%
110.306636266426662226655366347663820.19
210.376634966576664620.25
单位质量响应值RSD%判断
6444.856409.060.40数据可信
供试品溶液-2025082321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%
5min170302-7030298.35096.711.4698.3596.711.46
268852-6885296.32196.32
369437-6943797.14097.14
468721-6872196.13896.14
567503-6750394.43494.43
669951-6995197.85997.86
10min171186-7118699.58698.280.86100.6899.360.86
270314-7031498.36799.44
369736-6973697.55898.64
470603-7060398.77199.84
569537-6953797.28098.33
670136-7013698.11899.20
15min170246-7024698.27197.550.56100.4799.720.56
269776-6977697.61499.78
369976-6997697.894100.06
469319-6931996.97599.14
569250-6925096.87899.01
669832-6983297.69299.87
20min169196-6919696.80394.991.51100.0998.241.48
267977-6797795.09798.35
366907-6690793.60096.85
467673-6767394.67297.92
566710-6671093.32596.53
668930-6893096.43099.69
30min168221-6822195.43994.191.1599.8198.501.14
267639-6763994.62498.93
366195-6619592.60496.90
467431-6743194.33398.63
566621-6662193.20097.44
667876-6787694.95699.29
极限168145-6814595.33293.431.13100.7698.781.11
266972-6697293.69199.05
366322-6632292.78298.10
466105-6610592.47897.82
566301-6630192.75398.03
666875-6687593.55698.95
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)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%
110.306631266348665506630566315663660.16
210.376611865967660420.17
单位质量响应值RSD%判断
6443.306368.560.83数据可信
供试品溶液-2025082421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%
5min166751-6675193.69196.501.5893.6996.501.58
268716-6871696.44996.45
369076-6907696.95496.95
469965-6996598.20298.20
569276-6927697.23597.24
668741-6874196.48496.48
10min168901-6890196.70997.720.8397.7598.790.83
269780-6978097.94399.01
369198-6919897.12698.20
470366-7036698.76599.86
570145-7014598.45599.54
669335-6933597.31898.39
15min167376-6737694.56896.801.6396.6898.961.62
269078-6907896.95799.12
369256-6925697.20799.36
470572-7057299.054101.24
569475-6947597.51499.69
668050-6805095.51497.67
20min167417-6741794.62695.651.5697.7998.881.54
269068-6906896.943100.18
367961-6796195.38998.63
469432-6943297.454100.74
568435-6843596.05599.31
666569-6656993.43696.65
30min166520-6652093.36794.901.2097.5899.201.20
267817-6781795.18799.50
367764-6776495.11399.41
468718-6871896.452100.82
568027-6802795.48299.81
666847-6684793.82698.08
极限166183-6618392.89493.511.0798.1598.861.06
266627-6662793.51798.89
366858-6685893.84199.19
467918-6791895.329100.77
566084-6608492.75598.14
666065-6606592.72898.02
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)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%
110.306646866240664076624066446663600.17
210.376627166364663180.10
单位质量响应值RSD%判断
6442.726395.180.53数据可信
供试品溶液-2025082421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%
5min168940-6894096.56595.531.0196.5795.531.01
266978-6697893.81793.82
368554-6855496.02596.02
467924-6792495.14295.14
568539-6853996.00496.00
668279-6827995.63995.64
10min168772-6877296.33097.430.6897.4098.490.67
269307-6930797.07998.12
369782-6978297.74598.81
469512-6951297.36798.42
570029-7002998.09199.16
669936-6993697.96099.02
15min168766-6876696.32297.001.2298.4699.151.20
268111-6811195.40497.53
370029-7002998.091100.24
468663-6866396.17798.32
569938-6993897.963100.12
670008-7000898.061100.21
20min167852-6785295.04194.930.4498.2598.150.44
267570-6757094.64697.83
368342-6834295.72898.97
467642-6764294.74797.95
567582-6758294.66397.91
667646-6764694.75397.99
30min167067-6706793.94293.980.4198.2198.260.41
266910-6691093.72297.95
367220-6722094.15698.46
466799-6679993.56697.83
567009-6700993.86198.16
667565-6756594.63998.93
极限165523-6552391.77992.871.4597.0998.191.40
265382-6538291.58296.86
367420-6742094.43699.79
465572-6557291.84897.15
567459-6745994.49199.83
666455-6645593.08598.43
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