多替诺雷片项目信息
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D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.056611666015655836574265771658450.33
210.086587965967659230.10
单位质量响应值RSD%判断
6551.746539.980.13数据可信
供试品溶液-J049F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%
5min151858-5185871.07970.177.1071.0870.177.10
249439-4943967.76467.76
355728-5572876.38476.38
448876-4887666.99266.99
546397-4639763.59463.59
654873-5487375.21275.21
10min166633-6663391.33189.982.1991.4590.092.19
263809-6380987.46087.57
366709-6670991.43591.56
465064-6506489.18089.29
564345-6434588.19588.30
667308-6730892.25692.38
15min168832-6883294.34594.111.3294.6294.381.32
267145-6714592.03392.29
368472-6847293.85194.13
468829-6882994.34194.60
568735-6873594.21294.46
669960-6996095.89196.17
20min169954-6995495.88395.751.0596.3196.171.06
268633-6863394.07294.48
369724-6972495.56796.00
469891-6989195.79696.21
570035-7003595.99496.40
670913-7091397.19797.64
30min170355-7035596.43296.440.7797.0297.020.77
269579-6957995.36995.94
369997-6999795.94296.54
470446-7044696.55797.13
570660-7066096.85097.42
671130-7113097.49598.10
45min170237-7023796.27196.850.8697.0297.590.86
269744-6974495.59596.32
370664-7066496.85697.61
470895-7089597.17297.91
570939-7093997.23397.96
671476-7147697.96998.73
60min170239-7023996.27396.800.8797.1897.710.87
269739-6973995.58896.48
370611-7061196.78397.70
470607-7060796.77897.68
571066-7106697.40798.30
671486-7148697.98398.91
极限170978-7097897.28697.270.6998.3698.340.69
270958-7095897.25998.31
370873-7087397.14298.22
470229-7022996.26097.32
571003-7100397.32198.38
671763-7176398.36299.45
多替诺雷片项目信息
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D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.056562666038658656594765792658540.24
210.086660266853667280.27
单位质量响应值RSD%判断
6552.646619.840.73数据可信
供试品溶液-J049F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%
5min154182-5418273.81173.134.8473.8173.134.84
254528-5452874.28374.28
354432-5443274.15274.15
451438-5143870.07370.07
557433-5743378.24078.24
650073-5007368.21468.21
10min167217-6721791.56991.551.5491.6991.671.53
268545-6854593.37893.50
365724-6572489.53589.66
467731-6773192.26992.39
567689-6768992.21292.34
666318-6631890.34490.46
15min169263-6926394.35694.771.9094.6395.041.90
270928-7092896.62496.90
367332-6733291.72592.00
470890-7089096.57296.84
569389-6938994.52894.81
669599-6959994.81495.08
20min170068-7006895.45395.371.8695.8995.801.85
271482-7148297.37997.82
367668-6766892.18392.61
470871-7087196.54696.98
570012-7001295.37695.82
669935-6993595.27195.69
30min170865-7086596.53895.931.7497.1396.521.73
271731-7173197.71898.32
368305-6830593.05193.63
471342-7134297.18897.78
570036-7003695.40996.01
670228-7022895.67196.25
45min171249-7124997.06196.201.3697.8196.951.36
271445-7144597.32898.09
368906-6890693.87094.60
471305-7130597.13897.89
570426-7042695.94096.70
670367-7036795.86096.60
60min171164-7116496.94696.271.4997.8697.181.49
271502-7150297.40698.33
368733-6873393.63494.52
471464-7146497.35498.27
570269-7026995.72696.65
670860-7086096.53297.43
极限171316-7131697.15396.710.7198.2397.780.71
271564-7156497.49198.58
370340-7034095.82396.87
471080-7108096.83197.91
570413-7041395.92397.00
671211-7121197.01098.07
多替诺雷片项目信息
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D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.056580366063656006560665886657920.30
210.086635666593664740.26
单位质量响应值RSD%判断
6546.476594.640.52数据可信
供试品溶液-J050F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%
5min147680-4768065.10866.082.9265.1166.082.92
247556-4755664.93964.94
350751-5075169.30169.30
448362-4836266.03966.04
546811-4681163.92163.92
649207-4920767.19367.19
10min163618-6361886.87289.321.9186.9889.441.91
265997-6599790.12090.23
365538-6553889.49389.61
466406-6640690.67990.79
564203-6420387.67087.78
666722-6672291.11091.22
15min168519-6851993.56494.661.2493.8294.921.24
269658-6965895.11995.38
368812-6881293.96494.23
470313-7031396.01496.27
568415-6841593.42293.67
670231-7023195.90296.17
20min169802-6980295.31696.011.3695.7396.431.36
270877-7087796.78497.20
370121-7012195.75296.17
471242-7124297.28297.70
568740-6874093.86694.27
671086-7108697.06997.49
30min170333-7033396.04196.871.2696.6197.441.26
271499-7149997.63398.21
370599-7059996.40496.99
471692-7169297.89798.48
569631-6963195.08295.65
671873-7187398.14498.73
45min170448-7044896.19897.101.3796.9397.841.37
271911-7191198.19698.94
370673-7067396.50597.25
471679-7167997.87998.63
569725-6972595.21195.93
672208-7220898.60199.35
60min170798-7079896.67697.331.2497.5698.231.24
272234-7223498.63799.54
370684-7068496.52097.42
471702-7170297.91098.82
570085-7008595.70296.58
672163-7216398.54099.45
极限171068-7106897.04597.520.9798.0998.580.97
272273-7227398.69099.76
370599-7059996.40497.47
471885-7188598.16099.23
570780-7078096.65197.69
671876-7187698.14899.23
多替诺雷片项目信息
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D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.056640266588661306642166088663260.32
210.086703767139670880.11
单位质量响应值RSD%判断
6599.606655.560.60数据可信
供试品溶液-J050F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%
5min147728-4772864.61366.938.2964.6166.938.29
248862-4886266.14866.15
354347-5434773.57473.57
445073-4507361.01961.02
546065-4606562.36262.36
654548-5454873.84673.85
10min166194-6619489.61290.083.3189.7290.193.31
265991-6599189.33789.45
368396-6839692.59392.72
466275-6627589.72289.82
563026-6302685.32385.43
669350-6935093.88494.01
15min170137-7013794.95094.891.4395.2195.161.43
270307-7030795.18095.44
370514-7051495.46095.74
470013-7001394.78295.03
568293-6829392.45392.70
671311-7131196.53996.82
20min171510-7151096.80996.380.8997.2296.800.90
270951-7095196.05296.47
371343-7134396.58297.02
471138-7113896.30596.71
570162-7016294.98495.38
672051-7205197.54197.98
30min172313-7231397.89696.910.8098.4797.500.80
271363-7136396.61097.19
371746-7174697.12897.73
471502-7150296.79897.37
570657-7065795.65496.21
671941-7194197.39298.00
45min172196-7219697.73796.830.6798.4897.570.67
271786-7178697.18297.92
371656-7165697.00697.77
470992-7099296.10796.84
570981-7098196.09296.81
671533-7153396.84097.61
60min171856-7185697.27796.720.8098.1897.620.81
271574-7157496.89597.80
371964-7196497.42398.34
471088-7108896.23797.13
570471-7047195.40296.28
671715-7171597.08698.01
极限172271-7227197.83996.840.7398.9097.910.73
271811-7181197.21698.28
371816-7181697.22398.31
471077-7107796.22297.27
570905-7090595.99097.03
671328-7132896.56297.65
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