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)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%
119.599475894926945299489494941948100.19
219.489447194773946220.23
单位质量响应值RSD%判断
4839.714857.390.26数据可信
供试品溶液-2025032621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%
5min191868-9186896.78697.052.2296.7997.052.22
290505-9050595.35095.35
392961-9296197.93797.94
489752-8975294.55694.56
595558-95558100.673100.67
692050-9205096.97796.98
10min193831-9383198.85499.702.4899.0199.872.48
295800-95800100.928101.09
397661-97661102.889103.05
490874-9087495.73895.90
595849-95849100.980101.15
693815-9381598.83799.00
15min193388-9338898.38799.512.8298.7199.842.82
296223-96223101.374101.70
397913-97913103.154103.49
490720-9072095.57695.89
595827-95827100.957101.29
692655-9265597.61597.94
20min193673-9367398.68799.422.9099.1899.912.90
296223-96223101.374101.87
397864-97864103.103103.61
490280-9028095.11395.59
595547-95547100.662101.17
692609-9260997.56698.06
30min193458-9345898.46199.352.7899.12100.012.78
296210-96210101.360102.03
397669-97669102.897103.58
490535-9053595.38196.02
595427-95427100.535101.21
692509-9250997.46198.11
45min192950-9295097.92599.062.8298.7499.882.82
296053-96053101.195102.03
397574-97574102.797103.65
490474-9047495.31796.11
595003-95003100.088100.93
692110-9211097.04197.85
极限192715-9271597.67899.093.1898.66100.083.18
295740-95740100.865101.87
397910-97910103.151104.17
490241-9024195.07196.02
596156-96156101.303102.31
691561-9156196.46297.44
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)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%
119.599574795787959079576495757957920.07
219.489439394305943490.07
单位质量响应值RSD%判断
4889.844843.380.68数据可信
供试品溶液-2025032621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%
5min194370-9437099.05598.732.4299.0598.732.42
290248-9024894.72894.73
393686-9368698.33798.34
495370-95370100.104100.10
597080-97080101.899101.90
693633-9363398.28198.28
10min196784-96784101.588101.101.49101.75101.261.49
293650-9365098.29998.46
396116-96116100.887101.05
497014-97014101.830102.00
597859-97859102.717102.89
696463-96463101.251101.42
15min196916-96916101.727101.181.45102.06101.511.46
293758-9375898.41298.73
396855-96855101.663101.99
496504-96504101.294101.63
597909-97909102.769103.11
696418-96418101.204101.54
20min197022-97022101.838100.931.61102.34101.431.61
293334-9333497.96798.45
396670-96670101.469101.97
496748-96748101.551102.06
597621-97621102.467102.98
695529-95529100.271100.77
30min196622-96622101.418100.931.46102.09101.601.46
293682-9368298.33298.98
397397-97397102.232102.90
496010-96010100.776101.45
597473-97473102.312102.99
695784-95784100.539101.21
45min196997-96997101.812100.821.46102.65101.661.47
293479-9347998.11998.93
397171-97171101.995102.84
495994-95994100.759101.60
597004-97004101.819102.67
695666-95666100.415101.25
极限196772-96772101.576100.421.56102.59101.421.56
292863-9286397.47398.45
396616-96616101.412102.42
495729-95729100.481101.49
596675-96675101.474102.50
695353-95353100.086101.09
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)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%
119.591901131901301902711899211901861901240.07
219.481910421911691911060.05
单位质量响应值RSD%判断
9705.169810.370.77数据可信
供试品溶液-2025032621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%
5min1178532-17853293.46292.912.5893.4692.912.58
2175681-17568191.97091.97
3169427-16942788.69688.70
4178134-17813493.25493.25
5180609-18060994.54994.55
6182501-18250195.54095.54
10min1193173-193173101.12799.461.57101.2899.621.58
2188712-18871298.79198.94
3187648-18764898.23498.38
4187952-18795298.39498.55
5188086-18808698.46498.62
6194396-194396101.767101.93
15min1194741-194741101.948100.541.65102.27100.861.65
2191491-191491100.246100.56
3190967-19096799.972100.28
4189824-18982499.37499.69
5188441-18844198.65098.97
6196868-196868103.061103.39
20min1194987-194987102.076101.011.56102.57101.501.56
2192698-192698100.878101.36
3192727-192727100.893101.37
4191061-191061100.021100.51
5188798-18879898.83699.32
6197428-197428103.354103.85
30min1196229-196229102.727101.571.77103.39102.221.76
2194137-194137101.631102.28
3193514-193514101.305101.95
4192758-192758100.909101.56
5188656-18865698.76299.41
6198800-198800104.072104.75
45min1196971-196971103.115102.041.86103.95102.861.85
2195582-195582102.388103.21
3195000-195000102.083102.90
4194135-194135101.630102.45
5188512-18851298.68799.50
6199280-199280104.324105.17
极限1196157-196157102.689102.011.89103.70103.001.89
2195898-195898102.553103.55
3195525-195525102.358103.34
4193728-193728101.417102.41
5188364-18836498.60999.59
6199445-199445104.410105.43
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)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%
119.591901021899461899291900731898251899750.06
219.481897451898091897770.03
单位质量响应值RSD%判断
9697.559742.150.33数据可信
供试品溶液-2025032621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%
5min1171441-17144190.09890.124.1090.1090.124.10
2159324-15932483.73083.73
3174474-17447491.69291.69
4175299-17529992.12592.13
5168700-16870088.65788.66
6179698-17969894.43794.44
10min1193760-193760101.82799.112.10101.9899.262.10
2182794-18279496.06496.20
3190044-19004499.874100.03
4186563-18656398.04598.20
5186889-18688998.21698.36
6191478-191478100.628100.79
15min1196899-196899103.477100.662.00103.80100.972.00
2185941-18594197.71898.02
3192213-192213101.014101.33
4189536-18953699.60799.92
5190442-190442100.084100.39
6194194-194194102.055102.38
20min1198819-198819104.486101.231.92104.98101.721.93
2187730-18773098.65899.12
3192871-192871101.360101.85
4191101-191101100.430100.91
5191281-191281100.524101.00
6193991-193991101.949102.44
30min1199616-199616104.905101.861.81105.57102.511.81
2189396-18939699.534100.16
3193620-193620101.754102.41
4192205-192205101.010101.66
5192445-192445101.136101.78
6195641-195641102.816103.48
45min1200877-200877105.567102.341.86106.41103.171.86
2190020-19002099.862100.65
3194240-194240102.080102.91
4193781-193781101.838102.66
5193387-193387101.631102.45
6196147-196147103.082103.92
极限1200625-200625105.435102.151.72106.45103.141.71
2190638-190638100.187101.15
3194154-194154102.034103.03
4194121-194121102.017103.01
5193344-193344101.609102.59
6193330-193330101.601102.61
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