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4000
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%
119.659595595701957479574395600957490.14
219.759557695378954770.15
单位质量响应值RSD%判断
4872.724834.280.57数据可信
加速6月-供试品溶液-2025042321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%
5min197827-97827102.960102.441.16102.96102.441.16
295749-95749100.773100.77
397491-97491102.606102.61
496846-96846101.927101.93
599115-99115104.315104.32
696952-96952102.039102.04
10min198502-98502103.670103.421.44103.84103.591.44
296102-96102101.144101.31
398482-98482103.649103.82
497607-97607102.728102.90
5100417-100417105.686105.86
698492-98492103.660103.83
15min198287-98287103.444103.231.30103.79103.581.30
296019-96019101.057101.39
397772-97772102.902103.25
497888-97888103.024103.37
599901-99901105.143105.49
698659-98659103.835104.18
20min197942-97942103.081102.871.28103.60103.381.28
296005-96005101.042101.55
397749-97749102.878103.39
496915-96915102.000102.51
599706-99706104.937105.46
698138-98138103.287103.80
30min198102-98102103.249102.971.62103.94103.661.62
295093-95093100.082100.76
398400-98400103.563104.25
497650-97650102.773103.46
599975-99975105.220105.92
697795-97795102.926103.61
45min197695-97695102.821102.461.22103.68103.321.22
295537-95537100.550101.39
397094-97094102.188103.05
497235-97235102.337103.19
599230-99230104.436105.31
697330-97330102.437103.30
极限197602-97602102.723102.461.43103.76103.491.43
295242-95242100.239101.25
397248-97248102.350103.38
496966-96966102.054103.08
599587-99587104.812105.86
697478-97478102.592103.62
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4000
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%
119.659569295576958589563795839957200.13
219.759526995548954080.21
单位质量响应值RSD%判断
4871.254830.780.59数据可信
加速6月-供试品溶液-2025042322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%
5min197269-97269102.425100.682.04102.43100.682.04
298190-98190103.395103.39
396488-96488101.603101.60
494032-9403299.01799.02
594032-9403299.01799.02
693679-9367998.64598.64
10min198289-98289103.499101.721.99103.67101.891.99
299051-99051104.302104.47
397527-97527102.697102.87
494576-9457699.58999.75
595174-95174100.219100.38
694992-94992100.027100.19
15min197641-97641102.817101.381.88103.16101.721.88
298638-98638103.867104.21
397362-97362102.523102.86
494432-9443299.43899.77
594860-9486099.888100.22
694751-9475199.774100.10
20min197565-97565102.737101.461.83103.25101.961.83
298579-98579103.805104.32
397607-97607102.781103.29
494759-9475999.782100.28
594684-9468499.703100.20
694909-9490999.940100.44
30min197340-97340102.500101.151.87103.19101.831.87
298427-98427103.644104.34
397186-97186102.338103.02
494385-9438599.388100.05
594574-9457499.587100.25
694464-9446499.471100.14
45min197030-97030102.173100.871.70103.03101.721.70
297912-97912103.102103.97
396750-96750101.879102.73
494370-9437099.372100.20
594504-9450499.514100.34
694207-9420799.201100.03
极限196583-96583101.703100.691.92102.73101.701.92
298135-98135103.337104.37
396940-96940102.079103.10
493967-9396798.94899.94
594230-9423099.225100.22
693867-9386798.84399.84
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4000
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%
119.659568195710957479585595678957340.08
219.759527295404953380.10
单位质量响应值RSD%判断
4871.964827.240.66数据可信
加速6月-供试品溶液-2025042421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%
5min191983-9198396.88899.492.0296.8999.492.02
296972-96972102.143102.14
395347-95347100.431100.43
493051-9305198.01398.01
593528-9352898.51598.51
695863-95863100.974100.97
10min192847-9284797.798100.932.2197.96101.092.21
298318-98318103.560103.73
396936-96936102.105102.27
494374-9437499.40699.57
594871-9487199.930100.09
697552-97552102.753102.92
15min193139-9313998.105100.892.0798.43101.232.07
298229-98229103.467103.81
396958-96958102.128102.47
494309-9430999.33899.67
594841-9484199.898100.23
697233-97233102.417102.76
20min192833-9283397.783100.611.9898.27101.111.98
297749-97749102.961103.48
396491-96491101.636102.14
494107-9410799.12599.62
594879-9487999.938100.44
697048-97048102.223102.73
30min193134-9313498.100100.511.9598.75101.181.95
297882-97882103.101103.79
396666-96666101.820102.50
493886-9388698.89299.55
594457-9445799.493100.16
696497-96497101.642102.32
45min192727-9272797.671100.182.0198.49101.022.01
297419-97419102.613103.47
396201-96201101.330102.18
493321-9332198.29799.12
594369-9436999.401100.23
696602-96602101.753102.60
极限191876-9187696.77599.322.1897.75100.332.18
297185-97185102.367103.40
394210-9421099.233100.25
492404-9240497.33198.32
594005-9400599.017100.01
696098-96098101.222102.24
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4000
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%
119.659520095146955909545395240953260.20
219.759538995449954190.05
单位质量响应值RSD%判断
4851.204831.340.30数据可信
加速6月-供试品溶液-YAB2147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%
5min161389-6138964.77271.446.8964.7771.446.89
274786-7478678.90878.91
370346-7034674.22374.22
464677-6467768.24268.24
568658-6865872.44272.44
666412-6641270.07270.07
10min196319-96319101.628101.122.08101.74101.242.08
293287-9328798.42998.56
398904-98904104.355104.48
495872-95872101.156101.27
594074-9407499.25999.38
696564-96564101.886102.00
15min196272-96272101.578101.222.27101.86101.512.27
293075-9307598.20598.50
399183-99183104.649104.95
496008-96008101.299101.58
594040-9404099.22399.51
697016-97016102.363102.65
20min195874-95874101.158100.892.00101.60101.341.99
292807-9280797.92298.38
398455-98455103.881104.35
495834-95834101.116101.57
594388-9438899.590100.04
696357-96357101.668102.12
30min195853-95853101.136100.722.00101.75101.342.00
292638-9263897.74498.37
398208-98208103.621104.27
495380-95380100.637101.26
594220-9422099.413100.03
696426-96426101.741102.37
45min195901-95901101.187100.622.06101.97101.412.05
292552-9255297.65398.44
398164-98164103.574104.39
495487-95487100.750101.54
593837-9383799.00999.79
696242-96242101.546102.34
极限195144-95144100.388100.051.90101.34101.001.90
292317-9231797.40598.35
397473-97473102.845103.84
495096-95096100.337101.29
593336-9333698.48099.43
695553-95553100.819101.78
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