苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.571931271935251929941940941935941934670.23
219.671918281914291916280.15
单位质量响应值RSD%判断
9885.909742.151.04数据可信
供试品溶液-2025032621批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193566-9356697.405100.451.9797.41100.451.97
295876-9587699.81099.81
396072-96072100.014100.01
498068-98068102.092102.09
596338-96338100.291100.29
699011-99011103.073103.07
10min195768-9576899.697101.771.4499.86101.931.45
296803-96803100.775100.94
397623-97623101.629101.80
498789-98789102.842103.01
597802-97802101.815101.98
699743-99743103.835104.01
15min195791-9579199.721101.711.48100.05102.051.48
296584-96584100.547100.88
397519-97519101.520101.86
499145-99145103.213103.55
597648-97648101.655101.99
699519-99519103.602103.95
20min195400-9540099.314101.391.4499.81101.901.44
296679-96679100.646101.15
397042-97042101.024101.53
498688-98688102.737103.25
597308-97308101.301101.81
699273-99273103.346103.86
30min195098-9509899.000101.251.5199.66101.921.51
296241-96241100.190100.86
397060-97060101.042101.72
498615-98615102.661103.35
597507-97507101.508102.18
699026-99026103.089103.78
45min195071-9507198.972101.081.3999.80101.921.39
296368-96368100.322101.16
396734-96734100.703101.55
498485-98485102.526103.38
597274-97274101.265102.11
698638-98638102.685103.55
极限195016-9501698.915100.891.4499.90101.901.44
295857-9585799.790100.79
396527-96527100.488101.50
498263-98263102.295103.32
597241-97241101.231102.24
698601-98601102.647103.68
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.571932091934821932871934171934271933640.06
219.671927171924071925620.12
单位质量响应值RSD%判断
9880.639789.630.66数据可信
供试品溶液-2025032621批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194529-9452998.19397.692.6198.1997.682.61
294335-9433597.99297.99
390239-9023993.73793.74
492999-9299996.60496.60
594355-9435598.01298.01
697788-97788101.579101.58
10min195969-9596999.68998.912.7499.8599.072.74
295757-9575799.46999.63
391008-9100894.53694.69
494141-9414197.79097.95
595481-9548199.18299.35
698960-98960102.796102.97
15min195703-9570399.41398.943.0899.7499.273.08
295734-9573499.44599.77
390873-9087394.39594.71
493911-9391197.55197.88
595399-9539999.09799.43
699892-99892103.764104.10
20min196110-9611099.83598.842.85100.3399.342.85
295426-9542699.12599.62
390765-9076594.28394.75
494245-9424597.89898.38
595289-9528998.98399.48
699096-99096102.937103.45
30min195376-9537699.07398.402.7899.7399.062.78
295156-9515698.84499.50
390584-9058494.09594.72
493812-9381297.44898.10
594740-9474098.41299.07
698725-98725102.552103.24
45min195406-9540699.10498.362.7399.9399.182.73
295158-9515898.84799.67
390414-9041493.91994.70
493867-9386797.50698.32
594934-9493498.61499.44
698381-98381102.194103.05
极限195163-9516398.85298.082.9599.8499.072.95
294926-9492698.60699.60
389963-8996393.45094.39
493439-9343997.06198.04
594484-9448498.14699.13
698551-98551102.371103.40
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.571931911927681934181933691931371931770.14
219.671921381922491921940.05
单位质量响应值RSD%判断
9871.089770.920.73数据可信
供试品溶液-2025032621批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195048-9504898.87598.062.4898.8798.062.48
296324-96324100.202100.20
393972-9397297.75697.76
492346-9234696.06496.06
596972-96972100.876100.88
690906-9090694.56694.57
10min199038-99038103.025100.462.61103.19100.632.61
297718-97718101.652101.82
395271-9527199.10799.27
496608-96608100.498100.66
598554-98554102.522102.69
692257-9225795.97196.13
15min198582-98582102.551100.332.51102.89100.662.51
297630-97630101.561101.90
395033-9503398.85999.19
497022-97022100.928101.26
598205-98205102.159102.50
692224-9222495.93796.25
20min198426-98426102.389100.172.49102.90100.672.49
297469-97469101.393101.90
395201-9520199.03499.53
496514-96514100.400100.90
598116-98116102.066102.58
692043-9204395.74996.23
30min198840-98840102.819100.012.60103.50100.682.59
296934-96934100.837101.51
395015-9501598.84099.50
496242-96242100.117100.78
597978-97978101.923102.60
691841-9184195.53996.18
45min198991-98991102.97799.842.83103.83100.672.83
296686-96686100.579101.42
394420-9442098.22299.04
496461-96461100.345101.17
597899-97899101.841102.69
691401-9140195.08195.88
极限198029-98029101.97699.522.65103.00100.522.65
296884-96884100.785101.80
394342-9434298.14099.13
495611-9561199.460100.46
597801-97801101.739102.76
691353-9135395.03195.99
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.571924041924101927231922861921301923910.12
219.671919131917301918220.07
单位质量响应值RSD%判断
9830.919752.010.57数据可信
供试品溶液-2025032621批-pH1.1
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min190577-9057794.50795.443.8794.5195.443.87
286157-8615789.89589.90
390585-9058594.51594.52
491709-9170995.68895.69
597045-97045101.256101.26
692743-9274396.76796.77
10min196029-96029100.19699.692.78100.3599.842.78
297399-97399101.625101.77
391815-9181595.79995.96
493448-9344897.50397.66
599170-99170103.473103.64
695377-9537799.51599.68
15min196530-96530100.71899.822.96101.04100.152.95
298463-98463102.735103.05
391772-9177295.75496.07
493058-9305897.09697.42
598726-98726103.010103.35
695490-9549099.63399.96
20min196253-96253100.42999.743.29100.92100.233.28
298644-98644102.924103.41
391086-9108695.03895.51
492671-9267196.69297.18
598835-98835103.123103.64
696037-96037100.204100.70
30min196624-96624100.81799.583.21101.48100.233.21
298451-98451102.723103.38
391292-9129295.25395.89
492158-9215896.15796.80
598329-98329102.595103.28
695754-9575499.909100.57
45min195915-95915100.07799.293.18100.90100.113.17
298292-98292102.557103.39
391259-9125995.21996.01
491879-9187995.86696.67
598192-98192102.453103.31
695436-9543699.577100.40
极限195545-9554599.69198.933.23100.6999.923.23
297896-97896102.144103.15
390715-9071594.65195.60
491754-9175495.73596.70
598059-98059102.314103.34
694922-9492299.041100.03
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