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%
19.926533865360654886533365297653630.12
29.976490664982649440.09
单位质量响应值RSD%判断
6589.016513.940.82数据可信
供试品溶液-2025040121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%
5min169643-6964395.57995.172.6695.5895.172.65
268934-6893494.60694.61
369495-6949595.37595.38
466020-6602090.60690.61
571236-7123697.76597.76
670753-7075397.10297.10
10min171512-7151298.14497.291.1098.6797.821.11
271709-7170998.41498.94
370912-7091297.32097.85
469499-6949995.38195.88
570722-7072297.05997.60
670993-7099397.43197.97
15min170546-7054696.81897.070.9197.8998.140.90
272024-7202498.84699.92
370381-7038196.59197.66
470532-7053296.79997.83
570457-7045796.69697.78
670423-7042396.64997.73
20min170181-7018196.31796.640.7597.9398.250.75
271327-7132797.89099.51
370003-7000396.07397.68
469900-6990095.93197.50
570595-7059596.88598.50
670496-7049696.74998.37
30min170018-7001896.09396.360.6998.2498.500.69
270287-7028796.46298.63
370670-7067096.98899.13
469520-6952095.41097.51
570820-7082097.19499.35
669947-6994795.99698.15
极限169050-6905094.76595.501.3297.4598.181.30
269937-6993795.98298.68
369813-6981395.81298.49
468272-6827293.69796.33
569474-6947495.34798.04
670984-7098497.419100.11
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%
19.926471764803649086485564738648040.13
29.976485464806648300.06
单位质量响应值RSD%判断
6532.666502.510.33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%
5min162283-6228385.92087.1310.1885.9287.1310.18
254213-5421374.78774.79
357249-5724978.97578.98
469820-6982096.31796.32
569340-6934095.65595.65
666058-6605891.12791.13
10min166783-6678392.12893.985.6092.6094.465.63
263830-6383088.05488.47
363961-6396188.23588.67
472594-72594100.144100.68
571474-7147498.59999.13
670123-7012396.73597.24
15min167586-6758693.23595.183.0794.2296.193.11
266028-6602891.08691.99
367906-6790693.67794.61
471265-7126598.31199.40
570472-7047297.21798.30
670736-7073697.58198.62
20min169426-6942695.77496.271.5197.2897.801.56
267948-6794893.73595.15
369910-6991096.44197.89
471041-7104198.00299.64
569964-6996496.51698.14
670407-7040797.12798.71
30min168471-6847194.45696.061.2296.5098.121.24
268853-6885394.98396.91
370261-7026196.92598.91
470046-7004696.62998.81
569506-6950695.88498.04
670644-7064497.45499.58
极限168460-6846094.44196.281.4197.0098.881.41
268982-6898295.16197.62
371102-7110298.086100.61
469634-6963496.06198.78
569996-6999696.56099.25
670576-7057697.360100.03
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%
19.926487664875650686482164730648740.20
29.976474064896648180.18
单位质量响应值RSD%判断
6539.726501.300.42数据可信
供试品溶液-2025040121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%
5min165270-6527090.00092.191.3690.0092.191.36
267313-6731392.81792.82
366883-6688392.22492.22
466611-6661191.84991.85
567992-6799293.75493.75
667096-6709692.51892.52
10min168024-6802493.79894.280.6094.3094.800.60
268736-6873694.77995.30
368677-6867794.69895.21
467755-6775593.42793.94
568689-6868994.71595.24
668364-6836494.26794.78
15min168380-6838094.28993.770.7095.3194.800.70
267728-6772893.39094.43
367519-6751993.10194.14
467679-6767993.32294.35
568757-6875794.80895.86
667941-6794193.68394.72
20min167280-6728092.77293.011.1494.3294.561.13
268146-6814693.96695.53
367819-6781993.51595.07
466985-6698592.36593.91
568236-6823694.09095.66
666243-6624391.34292.90
30min166586-6658691.81592.551.1393.8894.621.11
267370-6737092.89694.98
366405-6640591.56593.64
466413-6641391.57693.64
567835-6783593.53795.63
668107-6810793.91295.98
极限166573-6657391.79792.100.5894.3794.690.58
266723-6672392.00494.60
366484-6648491.67494.26
466426-6642691.59494.16
567279-6727992.77095.39
667272-6727292.76195.35
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%
19.926490765102647916501764832649300.20
29.976500364954649780.06
单位质量响应值RSD%判断
6545.366517.350.31数据可信
供试品溶液-2025040121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%
5min167942-6794293.52992.301.2493.5392.301.24
268252-6825293.95593.96
366333-6633391.31491.31
466699-6669991.81891.82
566612-6661291.69891.70
666442-6644291.46491.46
10min168308-6830894.03394.311.2694.5594.821.25
269772-6977296.04896.57
368396-6839694.15494.66
467638-6763893.11093.62
569274-6927495.36295.87
667684-6768493.17493.68
15min168163-6816393.83394.381.1494.8795.421.14
269886-6988696.20597.26
367696-6769693.19094.22
468042-6804293.66694.69
568725-6872594.60795.65
668866-6886694.80195.83
20min166961-6696192.17892.961.4293.7494.521.41
269299-6929995.39796.99
366485-6648591.52393.07
467375-6737592.74894.30
567462-6746292.86894.43
667580-6758093.03094.58
30min167311-6731192.66092.921.0894.7495.001.08
268673-6867394.53596.66
366853-6685392.03094.09
467048-6704892.29894.36
566999-6699992.23194.31
668094-6809493.73895.81
极限166647-6664791.74692.391.4994.3494.991.47
269004-6900494.99197.64
366929-6692992.13494.70
466512-6651291.56094.14
567337-6733792.69695.29
666279-6627991.23993.83
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%
19.926487564710649286487664937648650.15
29.976470364509646060.22
单位质量响应值RSD%判断
6538.816480.040.64数据可信
供试品溶液-2025040121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166873-6687392.36993.241.5992.3793.241.59
269231-6923195.62695.63
368179-6817994.17394.17
466812-6681292.28492.28
567594-6759493.36593.36
666325-6632591.61291.61
10min168458-6845894.55893.771.7195.0794.291.70
269213-6921395.60196.13
368901-6890195.17095.69
467362-6736293.04493.56
566198-6619891.43691.96
667200-6720092.82093.33
15min167254-6725492.89593.161.1693.9394.191.16
268185-6818594.18195.24
368314-6831494.35995.41
467623-6762393.40594.43
567087-6708792.66493.69
666198-6619891.43692.46
20min166247-6624791.50492.241.4293.0693.791.42
267387-6738793.07994.66
368185-6818594.18195.76
465430-6543090.37691.92
566829-6682992.30893.85
666591-6659191.97993.51
30min166757-6675792.20992.081.2994.2794.141.28
268141-6814194.12096.22
366957-6695792.48594.58
465981-6598191.13793.19
566396-6639691.71093.76
665745-6574590.81192.85
极限165338-6533890.24990.731.8392.8293.321.80
267368-6736893.05295.68
366406-6640691.72494.34
464930-6493089.68592.24
563973-6397388.36390.93
666125-6612591.33693.88
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