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%
110.076659166729669006680666599667250.20
210.116648466531665080.05
单位质量响应值RSD%判断
6626.126578.440.52数据可信
供试品溶液-25021101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%
5min170764-7076496.36897.701.1496.3797.701.14
272474-7247498.69798.70
372740-7274099.05999.06
471305-7130597.10597.10
572107-7210798.19798.20
671053-7105396.76196.76
10min172445-7244598.65799.640.9098.8299.800.90
273584-73584100.208100.37
374132-74132100.954101.12
472659-7265998.94999.11
573431-73431100.000100.16
672728-7272899.04299.20
15min172433-7243398.64199.600.8398.9799.930.82
273852-73852100.573100.90
373899-73899100.637100.97
472950-7295099.34599.67
572956-7295699.35399.68
672756-7275699.08199.41
20min172310-7231098.47399.600.8398.96100.100.83
273781-73781100.476100.98
373877-73877100.607101.11
472873-7287399.24099.73
573161-7316199.632100.13
672822-7282299.17199.66
30min172103-7210398.19199.210.9498.8499.870.94
273807-73807100.512101.18
373426-7342699.993100.66
472314-7231498.47999.14
573053-7305399.485100.15
672405-7240598.60399.26
极限172142-7214298.24499.110.8099.0699.940.81
273597-73597100.226101.06
373293-7329399.812100.65
472226-7222698.35999.18
572844-7284499.200100.03
672571-7257198.82999.65
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%
110.076657466584665776666866750666310.12
210.116652966675666020.16
单位质量响应值RSD%判断
6616.786587.730.32数据可信
供试品溶液-25022101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%
5min173043-7304399.47198.341.3899.4798.341.38
270896-7089696.54796.55
371478-7147897.34097.34
473563-73563100.179100.18
571913-7191397.93297.93
672367-7236798.55098.55
10min173889-73889100.62399.971.13100.79100.131.13
272765-7276599.09299.25
372539-7253998.78598.95
474333-74333101.228101.39
574220-74220101.074101.24
672711-7271199.01999.18
15min173672-73672100.32899.901.23100.66100.231.23
272707-7270799.01399.34
372468-7246898.68899.01
474202-74202101.049101.38
574539-74539101.508101.84
672563-7256398.81799.15
20min175327-75327102.581100.211.55103.08100.701.55
272741-7274199.06099.55
372589-7258998.85399.34
474251-74251101.116101.62
574047-74047100.838101.34
672543-7254398.79099.28
30min173383-7338399.93499.481.26100.61100.141.26
272447-7244798.65999.32
372094-7209498.17998.83
474101-74101100.912101.58
574055-74055100.849101.52
672207-7220798.33298.99
极限172795-7279599.13399.071.1699.9799.901.16
272090-7209098.17398.99
371905-7190597.92198.74
473583-73583100.206101.05
573924-73924100.671101.51
672194-7219498.31599.14
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%
110.076672966656666266649666670666350.13
210.116669766743667200.05
单位质量响应值RSD%判断
6617.186599.410.20数据可信
供试品溶液-25022601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%
5min167342-6734291.62393.731.6291.6293.731.62
268120-6812092.68292.68
369046-6904693.94293.94
470459-7045995.86495.86
569718-6971894.85694.86
668661-6866193.41893.42
10min169959-6995995.18495.870.8595.3496.030.85
270621-7062196.08596.24
370238-7023895.56395.72
471541-7154197.33697.50
570505-7050595.92796.08
669920-6992095.13195.29
15min170248-7024895.57796.080.9695.8996.390.96
271132-7113296.78097.09
370140-7014095.43095.75
471660-7166097.49897.82
570646-7064696.11996.44
669859-6985995.04895.36
20min169524-6952494.59295.720.9295.0696.200.92
270815-7081596.34896.82
370475-7047595.88696.36
471233-7123396.91797.40
570349-7034995.71496.19
669731-6973194.87495.35
30min169827-6982795.00495.891.2395.6396.521.23
270716-7071696.21496.85
370351-7035195.71796.35
472028-7202897.99998.64
570363-7036395.73396.37
669568-6956894.65295.28
极限169701-6970194.83395.611.0295.6296.411.02
270750-7075096.26097.06
369958-6995895.18295.98
471468-7146897.23798.05
570140-7014095.43096.23
669610-6961094.70995.50
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%
110.076668566702668516686666749667710.13
210.116638466559664720.19
单位质量响应值RSD%判断
6630.696574.880.60数据可信
供试品溶液-25021101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%
5min171573-7157397.46397.171.1397.4697.171.13
272128-7212898.21898.22
371119-7111996.84496.84
470687-7068796.25696.26
572344-7234498.51398.51
670297-7029795.72595.73
10min172086-7208698.16198.281.4998.3298.441.48
272782-7278299.10999.27
372840-7284099.18899.35
471278-7127897.06197.22
573436-73436100.000100.16
670595-7059596.13196.29
15min171953-7195397.98098.371.2598.3198.701.25
272824-7282499.16699.50
372790-7279099.12099.45
471258-7125897.03497.36
573401-7340199.952100.28
671224-7122496.98797.31
20min172267-7226798.40898.221.1698.9098.711.16
272646-7264698.92499.42
372446-7244698.65199.14
471089-7108996.80497.29
573162-7316299.626100.12
671153-7115396.89197.37
30min172010-7201098.05898.151.2998.7198.801.29
272539-7253998.77899.44
372495-7249598.71899.37
471221-7122196.98397.63
573355-7335599.889100.55
670830-7083096.45197.09
极限171803-7180397.77697.881.2898.5998.701.28
272370-7237098.54899.37
372399-7239998.58799.41
470843-7084396.46997.28
573086-7308699.523100.35
670791-7079196.39897.20
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