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%
110.306610566318663506683166993665190.57
210.376704766842669440.22
单位质量响应值RSD%判断
6458.166455.540.03数据可信
供试品溶液-AFP05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%
5min172318-72318100.70198.471.24100.7098.471.24
270016-7001697.49697.50
370071-7007197.57297.57
470186-7018697.73297.73
570758-7075898.52998.53
670931-7093198.77098.77
10min172076-72076100.36499.100.92100.9299.650.91
271059-7105998.94899.49
370405-7040598.03798.58
470753-7075398.52299.06
570897-7089798.72299.27
671826-71826100.016100.56
15min172712-72712101.25098.331.66102.3799.431.65
269747-6974797.12198.21
370647-7064798.37499.46
470155-7015597.68998.78
569457-6945796.71797.81
670972-7097298.82799.93
20min171763-7176399.92897.031.90101.6198.671.89
268742-6874295.72197.35
368710-6871095.67797.31
469216-6921696.38298.01
568763-6876395.75197.38
670896-7089698.721100.37
30min170047-7004797.53996.831.0799.7799.011.07
269619-6961996.94399.11
369109-6910996.23398.40
468735-6873595.71297.88
568999-6899996.07998.24
670708-7070898.459100.66
极限168142-6814294.88695.690.9097.6698.400.87
267852-6785294.48297.18
368909-6890995.95498.65
468857-6885795.88298.58
569011-6901196.09698.79
669533-6953396.82399.57
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%
110.306703366835669586703166991669700.13
210.376676966757667630.02
单位质量响应值RSD%判断
6501.946438.090.70数据可信
供试品溶液-AFP05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%
5min170976-7097698.63497.821.0398.6397.821.03
269738-6973896.91396.91
369524-6952496.61696.62
470337-7033797.74697.75
571430-7143099.26499.26
670357-7035797.77397.77
10min171259-7125999.02798.420.6899.5798.970.68
270369-7036997.79098.33
370603-7060398.11598.65
470670-7067098.20898.75
571576-7157699.467100.02
670473-7047397.93598.48
15min170105-7010597.42397.501.2098.5298.601.20
269701-6970196.86297.94
369653-6965396.79597.88
469742-6974296.91998.01
571845-7184599.841100.95
669930-6993097.18098.27
20min171987-71987100.03996.801.69101.6898.431.66
269483-6948396.55998.18
368832-6883295.65497.27
469356-6935696.38298.01
568917-6891795.77297.43
669369-6936996.40098.03
30min168251-6825194.84795.830.8797.0498.000.85
268432-6843295.09897.25
369175-6917596.13198.28
469018-6901895.91398.08
569926-6992697.17499.37
668955-6895595.82597.99
极限170584-7058498.08996.371.70100.8199.071.67
267847-6784794.28596.97
369735-6973596.90999.59
468659-6865995.41498.11
570703-7070398.254100.98
668544-6854495.25497.95
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%
110.306675266556667966674266726667140.14
210.376672966640666840.10
单位质量响应值RSD%判断
6477.096430.470.52数据可信
供试品溶液-AFS03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%
5min173056-73056101.77896.413.24101.7896.413.24
268162-6816294.96094.96
369554-6955496.90096.90
466321-6632192.39592.40
568495-6849595.42495.42
669617-6961796.98796.99
10min169105-6910596.27495.911.0696.8496.441.06
268911-6891196.00496.53
369336-6933696.59697.13
467407-6740793.90894.42
569310-6931096.56097.09
668985-6898596.10796.65
15min168749-6874995.77895.611.4896.8896.681.48
269158-6915896.34897.41
369167-6916796.36097.44
466595-6659592.77793.81
569160-6916096.35197.42
668926-6892696.02597.10
20min169114-6911496.28794.841.4997.9296.441.49
267810-6781094.47096.07
367859-6785994.53896.15
466297-6629792.36293.91
568626-6862695.60797.21
668750-6875095.77997.39
30min167813-6781394.47494.451.4896.6496.581.47
267493-6749394.02896.15
368784-6878495.82797.96
466160-6616092.17194.23
568908-6890896.00098.13
667635-6763594.22696.36
极限167966-6796694.68794.110.9497.3896.760.95
267947-6794794.66197.30
368186-6818694.99497.66
466465-6646592.59695.17
567457-6745793.97896.64
667278-6727893.72996.39
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%
110.306665166771666786647266676666500.17
210.376666066576666180.09
单位质量响应值RSD%判断
6470.876424.110.52数据可信
供试品溶液-AFS03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%
5min169486-6948696.89995.711.3396.9095.711.33
269262-6926296.58796.59
368408-6840895.39695.40
467551-6755194.20194.20
569488-6948896.90296.90
667591-6759194.25794.26
10min168207-6820795.11695.641.3095.6596.171.30
267657-6765794.34994.89
368877-6887796.05096.58
468768-6876895.89896.42
570107-7010797.76598.30
667866-6786694.64095.16
15min168389-6838995.36995.200.5596.4496.260.55
267657-6765794.34995.41
368342-6834295.30496.37
468078-6807894.93695.99
568781-6878195.91697.00
668351-6835195.31696.37
20min171219-7121999.31696.651.72100.9198.241.69
268275-6827595.21096.80
367915-6791594.70896.30
469454-6945496.85598.44
569872-6987297.43899.05
669100-6910096.36197.94
30min167107-6710793.58294.820.9995.7396.950.97
267370-6737093.94896.06
367831-6783194.59196.71
468578-6857895.63397.75
568734-6873495.85198.01
668358-6835895.32697.44
极限167512-6751294.14694.561.0996.8197.211.08
267590-6759094.25596.89
367516-6751694.15296.80
468004-6800494.83397.49
569176-6917696.46799.16
667039-6703993.48796.13
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%
110.306671966946665866652666687666930.25
210.376659766596665960.01
单位质量响应值RSD%判断
6475.056421.990.59数据可信
供试品溶液-AGP01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%
5min171557-7155799.772100.611.2699.77100.621.26
270977-7097798.96398.96
372134-72134100.576100.58
473010-73010101.798101.80
571894-71894100.242100.24
673397-73397102.337102.34
10min172017-72017100.413101.591.25100.97102.151.25
272066-72066100.481101.03
373230-73230102.104102.66
473433-73433102.387102.95
572198-72198100.665101.22
674235-74235103.506104.07
15min171672-7167299.932100.460.71101.04101.590.71
271731-71731100.014101.12
372703-72703101.370102.50
472642-72642101.285102.42
572055-72055100.466101.58
671519-7151999.719100.86
20min171390-7139099.539100.591.32101.21102.271.30
273295-73295102.195103.86
371415-7141599.574101.26
471726-71726100.007101.70
571607-7160799.841101.52
673420-73420102.369104.07
30min170485-7048598.27798.871.48100.50101.121.46
269611-6961197.05899.29
370445-7044598.221100.46
471265-7126599.365101.62
570957-7095798.935101.16
672718-72718101.391103.66
极限169962-6996297.54898.181.21100.31100.971.19
270151-7015197.811100.58
369463-6946396.85299.64
470541-7054198.355101.16
570429-7042998.199100.98
671958-71958100.331103.16
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%
110.306675066707666616670466729667100.05
210.376651066525665180.02
单位质量响应值RSD%判断
6476.706414.460.69数据可信
供试品溶液-AGP01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%
5min172602-72602101.27699.781.05101.2899.781.05
271364-7136499.54999.55
371495-7149599.73199.73
471170-7117099.27899.28
570448-7044898.27198.27
672079-72079100.546100.55
10min172270-72270100.812100.181.08101.38100.731.08
272070-72070100.533101.09
371363-7136399.547100.10
472539-72539101.188101.74
570451-7045198.27598.82
672194-72194100.706101.26
15min171979-71979100.40699.501.25101.53100.611.24
271695-71695100.010101.12
371046-7104699.105100.21
470166-7016697.87798.99
570579-7057998.45499.55
672513-72513101.151102.27
20min171881-71881100.27098.971.19101.95100.631.18
269769-6976997.32498.99
370502-7050298.346100.00
471251-7125199.391101.05
570480-7048098.31599.95
671809-71809100.169101.85
30min170517-7051798.36797.831.33100.60100.051.31
269442-6944296.86899.08
371386-7138699.579101.78
469123-6912396.42398.63
569420-6942096.83799.02
670920-7092098.929101.17
极限169216-6921696.55296.940.9299.3499.700.91
269289-6928996.65499.40
369817-6981797.391100.15
469453-6945396.88399.63
568657-6865795.77298.50
670535-7053598.392101.18
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