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%
110.306673765921663356651366451663910.46
210.376661066631666200.03
单位质量响应值RSD%判断
6445.736424.300.24数据可信
供试品溶液-AFP05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%
5min171848-71848100.38697.991.72100.3997.991.72
270597-7059798.63898.64
368194-6819495.28195.28
470260-7026098.16898.17
569588-6958897.22997.23
670302-7030298.22698.23
10min171457-7145799.84099.800.39100.40100.350.39
271362-7136299.707100.26
371312-7131299.637100.17
471076-7107699.30899.85
571908-71908100.470101.01
671464-7146499.850100.40
15min169995-6999597.79798.110.9898.9199.210.96
269853-6985397.59998.70
369914-6991497.68498.77
470810-7081098.936100.03
569458-6945897.04798.15
671280-7128099.593100.69
20min171266-7126699.57398.061.23101.2399.711.22
269484-6948497.08398.73
368892-6889296.25697.88
470415-7041598.384100.03
570334-7033498.27199.91
670729-7072998.823100.48
30min169279-6927996.79796.570.7299.0198.760.71
269819-6981997.55199.73
368579-6857995.81997.98
469336-6933696.87799.07
568522-6852295.73997.92
669158-6915896.62898.83
极限168167-6816795.24395.561.2597.9998.291.23
267927-6792794.90897.63
367437-6743794.22396.92
469239-6923996.74199.47
567964-6796494.96097.67
669642-6964297.304100.04
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%
110.306665566864668516663766804667620.17
210.376655466526665400.03
单位质量响应值RSD%判断
6481.756416.590.72数据可信
供试品溶液-AFP05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%
5min169770-6977097.27194.597.4797.2794.607.47
269891-6989197.44097.44
357556-5755680.24380.24
469085-6908596.31696.32
570532-7053298.33498.33
670268-7026897.96597.97
10min170277-7027797.97899.340.8198.5299.860.81
271167-7116799.21999.76
371176-7117699.23199.68
471515-7151599.704100.24
571346-7134699.468100.01
672037-72037100.432100.98
15min169707-6970797.18398.360.9298.2799.440.92
270577-7057798.39699.49
370196-7019697.86598.86
470503-7050398.29399.38
570672-7067298.52999.63
671657-7165799.902101.00
20min169832-6983297.35897.710.9298.9899.340.88
270029-7002997.63299.27
371150-7115099.195100.74
469285-6928596.59598.23
569778-6977897.28298.93
670449-7044998.21899.88
30min169670-6967097.13296.521.1499.3098.691.12
268906-6890696.06798.25
368850-6885095.98998.08
468574-6857495.60497.78
570636-7063698.479100.67
668756-6875695.85798.06
极限167614-6761494.26595.490.8396.9798.190.82
268806-6880695.92798.64
368224-6822495.11697.74
469297-6929796.61299.31
568415-6841595.38298.12
668597-6859795.63698.37
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%
110.306672966620665716680866545666550.17
210.376668666626666560.07
单位质量响应值RSD%判断
6471.366427.770.48数据可信
供试品溶液-AFS03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%
5min168972-6897296.15195.250.9896.1595.250.98
268857-6885795.99195.99
368520-6852095.52195.52
468479-6847995.46495.46
567948-6794894.72494.72
667185-6718593.66093.66
10min169303-6930396.61397.040.5597.1597.560.55
270140-7014097.78098.31
369532-6953296.93297.46
469293-6929396.59997.13
570028-7002897.62398.15
669347-6934796.67497.19
15min168159-6815995.01896.661.4596.0997.731.44
270565-7056598.37299.45
369868-6986897.40098.47
468952-6895296.12397.19
570163-7016397.81298.88
668328-6832895.25496.31
20min169473-6947396.85096.840.6198.4598.440.61
270009-7000997.59799.22
369921-6992197.47499.08
469276-6927696.57598.18
569159-6915996.41298.02
668962-6896296.13797.72
30min168574-6857495.59694.960.7397.7397.100.72
268609-6860995.64597.81
368448-6844895.42197.57
467623-6762394.27196.41
567947-6794794.72296.87
667502-6750294.10296.22
极限167526-6752694.13694.590.6196.8097.260.61
268559-6855995.57698.27
368091-6809194.92397.61
467567-6756794.19396.85
567536-6753694.14996.82
667831-6783194.56197.20
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%
110.306666266858666746652666463666370.23
210.376644766488664680.05
单位质量响应值RSD%判断
6469.616409.640.66数据可信
供试品溶液-AFS03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%
5min168979-6897996.31095.491.7896.3195.491.78
266045-6604592.21492.21
368918-6891896.22596.23
468317-6831795.38695.39
568629-6862995.82295.82
669462-6946296.98596.98
10min170701-7070198.71597.181.3999.2597.711.38
269368-6936896.85497.37
370222-7022298.04698.58
468156-6815695.16195.69
568920-6892096.22896.76
670252-7025298.08898.63
15min170593-7059398.56497.150.9499.6598.220.93
269739-6973997.37298.42
369333-6933396.80597.88
468584-6858495.75996.82
569642-6964297.23698.30
669584-6958497.15598.24
20min170044-7004497.79796.820.7099.4398.430.70
269313-6931396.77798.37
369109-6910996.49298.11
468782-6878296.03597.63
569019-6901996.36697.97
669788-6978897.44099.06
30min168790-6879096.04794.630.8598.2296.780.84
267959-6795994.88697.02
367688-6768894.50896.66
467415-6741594.12796.25
567118-6711893.71295.85
667689-6768994.50996.67
极限167880-6788094.77694.531.2197.4897.201.19
267686-6768694.50597.16
368798-6879896.05898.74
466697-6669793.12495.77
566856-6685693.34696.01
668301-6830195.36498.05
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%
110.306664466722667846660166721666940.11
210.376666366724666940.07
单位质量响应值RSD%判断
6475.156431.440.48数据可信
供试品溶液-AGP01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%
5min169264-6926496.50393.527.4896.5093.527.47
269630-6963097.01397.01
356973-5697379.37879.38
468984-6898496.11396.11
567990-6799094.72894.73
669890-6989097.37597.37
10min171186-7118699.18196.294.9099.7296.824.92
270337-7033797.99898.54
362472-6247287.04087.48
469560-6956096.91597.45
569348-6934896.62097.15
671785-71785100.015100.56
15min169713-6971397.12896.682.7898.2297.742.82
270276-7027697.91399.00
365679-6567991.50892.43
469678-6967897.07998.15
569681-6968197.08498.15
671328-7132899.378100.47
20min171434-7143499.52696.371.94101.1597.961.96
269600-6960096.97198.60
367723-6772394.35695.79
468670-6867095.67597.29
568065-6806594.83296.43
669515-6951596.85298.50
30min168946-6894696.06096.031.1998.2498.151.18
269307-6930796.56398.73
369066-6906696.22798.18
467515-6751594.06696.21
568713-6871395.73597.86
669987-6998797.51099.70
极限169823-6982397.28196.091.0699.9998.751.04
268198-6819895.01797.72
369013-6901396.15398.64
468057-6805794.82197.49
569063-6906396.22398.88
669645-6964597.03399.76
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%
110.306649066615666006663566551665780.09
210.376650766444664760.07
单位质量响应值RSD%判断
6463.886410.410.59数据可信
供试品溶液-AGP01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%
5min170119-7011997.93996.452.0397.9496.452.03
266426-6642692.78192.78
369361-6936196.88196.88
470168-7016898.00898.01
569550-6955097.14597.14
668695-6869595.95095.95
10min170303-7030398.19697.981.1498.7498.521.13
270396-7039698.32698.84
370925-7092599.06599.60
470257-7025798.13298.68
570419-7041998.35898.90
668598-6859895.81596.35
15min170082-7008297.88897.680.9298.9898.760.91
270050-7005097.84398.90
370666-7066698.70399.79
469596-6959697.20998.30
568842-6884296.15697.24
670350-7035098.26299.33
20min168587-6858795.80096.250.7597.4397.870.74
269054-6905496.45298.06
369044-6904496.43898.07
469798-6979897.49199.12
568412-6841295.55597.18
668555-6855595.75597.37
30min168280-6828095.37195.890.8797.5498.050.86
268279-6827995.36997.51
369162-6916296.60398.78
468642-6864295.87698.05
567993-6799394.97097.12
669550-6955097.14599.29
极限167452-6745294.21495.651.7296.9198.341.67
268545-6854595.74198.41
369036-6903696.42799.14
467444-6744494.20396.91
570500-7050098.472101.15
667887-6788794.82297.50
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