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%
110.076669666700668196686066682667510.13
210.116682566738667820.10
单位质量响应值RSD%判断
6628.706605.540.25数据可信
供试品溶液-25021101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%
5min172788-7278898.90198.740.9498.9098.740.94
272004-7200497.83697.84
372318-7231898.26298.26
472764-7276498.86898.87
572241-7224198.15898.16
673903-73903100.416100.42
10min172952-7295299.12499.700.5599.2999.870.55
273265-7326599.54999.71
373050-7305099.25799.42
473642-73642100.061100.23
573340-7334099.65199.81
674026-74026100.583100.75
15min173154-7315499.39899.580.4899.7399.910.48
273093-7309399.31599.64
372891-7289199.04199.37
473355-7335599.671100.00
573346-7334699.65999.99
673903-73903100.416100.75
20min172780-7278098.89099.170.3799.3999.670.37
272838-7283898.96999.46
372670-7267098.74199.23
473055-7305599.26499.76
573265-7326599.549100.04
673313-7331399.614100.12
30min172185-7218598.08298.780.6198.7499.440.61
272233-7223398.14798.81
372670-7267098.74199.40
473086-7308699.30699.97
572713-7271398.79999.46
673286-7328699.578100.25
极限172525-7252598.54498.880.5199.3799.700.51
272582-7258298.62199.44
372313-7231398.25599.08
472843-7284398.97699.80
573042-7304299.246100.07
673319-7331999.622100.46
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%
110.076672166743667656672966759667430.03
210.116674966763667560.02
单位质量响应值RSD%判断
6627.906602.970.27数据可信
供试品溶液-25022101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%
5min172834-7283498.98999.030.4698.9999.030.45
272579-7257998.64298.64
373471-7347199.85499.85
472724-7272498.83998.84
572618-7261898.69598.70
672959-7295999.15899.16
10min173471-7347199.85499.580.43100.0299.740.43
273149-7314999.41799.58
373728-73728100.204100.37
473349-7334999.68999.85
573036-7303699.26399.43
672882-7288299.05499.22
15min173149-7314999.41799.510.3999.7599.840.39
272995-7299599.20799.54
373531-7353199.936100.27
473180-7318099.45999.79
572879-7287999.05099.38
673576-7357699.997100.33
20min173019-7301999.24098.571.9699.7499.071.95
269687-6968794.71295.21
372944-7294499.13899.64
472924-7292499.11199.61
572990-7299099.20199.70
673613-73613100.047100.54
30min172492-7249298.52498.910.5599.1999.580.54
272686-7268698.78799.44
373427-7342799.795100.46
472512-7251298.55199.21
572469-7246998.49399.15
673087-7308799.332100.00
极限172579-7257998.64298.550.5299.4799.380.52
272312-7231298.27999.10
373040-7304099.269100.10
472601-7260198.67299.50
571919-7191997.74598.57
672621-7262198.69999.53
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%
110.076670766874667316677066773667710.10
210.116668266758667200.09
单位质量响应值RSD%判断
6630.696599.410.34数据可信
供试品溶液-25022601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%
5min165167-6516788.57492.753.1788.5792.763.18
265887-6588789.55289.55
370114-7011495.29895.30
468991-6899193.77193.77
570076-7007695.24695.25
669224-6922494.08894.09
10min170914-7091496.38596.360.9396.5396.520.93
269595-6959594.59294.74
371167-7116796.72996.89
471096-7109696.63296.79
571229-7122996.81396.97
671380-7138097.01897.18
15min170900-7090096.36696.410.9596.6796.730.95
269663-6966394.68594.99
371173-7117396.73797.06
471154-7115496.71197.03
571054-7105496.57596.90
671656-7165697.39497.71
20min170463-7046395.77296.550.5196.2497.020.51
271498-7149897.17997.64
371146-7114696.70097.18
470959-7095996.44696.92
570870-7087096.32596.81
671273-7127396.87397.35
30min170790-7079096.21696.230.5296.8496.860.51
271285-7128596.88997.52
370554-7055495.89696.54
470248-7024895.48096.12
570901-7090196.36797.01
671015-7101596.52297.16
极限170952-7095296.43796.110.4397.2396.900.42
270827-7082796.26797.05
370631-7063196.00096.80
470420-7042095.71496.51
570339-7033995.60396.41
671086-7108696.61997.42
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%
110.076686366790668876684866851668480.06
210.116671266612666620.11
单位质量响应值RSD%判断
6638.336593.670.48数据可信
供试品溶液-25022101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%
5min173712-73712100.17498.871.22100.1798.871.22
271338-7133896.94896.95
372671-7267198.75998.76
473118-7311899.36799.37
572181-7218198.09498.09
673478-7347899.85699.86
10min173396-7339699.74599.980.4799.91100.140.47
273794-73794100.286100.45
373418-7341899.77599.94
473803-73803100.298100.46
573032-7303299.25099.41
673952-73952100.500100.67
15min173464-7346499.83799.770.50100.17100.110.50
273303-7330399.61899.95
373591-73591100.010100.34
473075-7307599.30899.64
573055-7305599.28199.61
674021-74021100.594100.93
20min173287-7328799.59799.780.75100.10100.280.75
273231-7323199.520100.02
373117-7311799.36699.86
473639-73639100.075100.57
572847-7284798.99999.49
674416-74416101.131101.63
30min173278-7327899.58499.400.29100.25100.060.30
272916-7291699.09299.75
373137-7313799.393100.06
473191-7319199.466100.13
572885-7288599.05099.71
673436-7343699.799100.47
极限173245-7324599.53999.450.44100.37100.280.44
273068-7306899.299100.12
373239-7323999.531100.36
473235-7323599.526100.36
572645-7264598.72499.55
673625-73625100.056100.89
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%
110.076684566769667886668166750667670.09
210.116645566598665260.16
单位质量响应值RSD%判断
6630.296580.220.54数据可信
供试品溶液-25022601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%
5min171035-7103596.69396.111.5296.6996.111.52
270009-7000995.29795.30
370267-7026795.64895.65
469105-6910594.06694.07
570995-7099596.63996.64
672236-7223698.32898.33
10min170842-7084296.43197.180.7496.5997.340.74
270680-7068096.21096.37
371530-7153097.36797.53
471535-7153597.37497.53
571759-7175997.67997.84
672027-7202798.04498.21
15min170976-7097696.61397.320.8896.9497.640.88
271319-7131997.08097.40
371224-7122496.95197.27
471422-7142297.22097.54
571299-7129997.05397.38
672731-7273199.00299.33
20min171360-7136097.13697.040.6097.6297.520.60
270750-7075096.30696.79
371022-7102296.67697.16
471437-7143797.24197.72
571162-7116296.86697.35
671991-7199197.99598.49
30min171051-7105196.71596.970.7397.3697.620.74
270622-7062296.13196.77
371010-7101096.65997.30
471248-7124896.98397.63
571321-7132197.08397.73
672171-7217198.24098.90
极限170995-7099596.63996.900.7097.4597.710.70
270692-7069296.22797.03
371056-7105696.72297.53
471236-7123696.96797.77
571010-7101096.65997.47
672131-7213198.18599.00
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