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%
119.419791698195981789783298108980460.17
219.459834598457984010.09
单位质量响应值RSD%判断
5051.315059.180.12数据可信
长期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%
5min198465-9846599.49499.004.3599.4999.004.34
299562-99562100.602100.60
399090-99090100.126100.13
4101256-101256102.314102.31
589512-8951290.44790.45
699992-99992101.037101.04
10min199909-99909100.953101.890.73101.12102.060.73
2100993-100993102.048102.22
3100051-100051101.097101.26
4101661-101661102.723102.89
5100861-100861101.915102.07
6101549-101549102.610102.78
15min199544-99544100.584101.600.80100.92101.930.80
2100762-100762101.815102.15
399831-99831100.874101.21
4101807-101807102.871103.21
5100658-100658101.710102.03
6100683-100683101.735102.07
20min199887-99887100.931101.430.46101.43101.940.47
2100441-100441101.491102.00
3100414-100414101.463101.97
4101170-101170102.227102.74
599943-99943100.987101.48
6100433-100433101.483101.99
30min199329-99329100.367101.340.69101.04102.010.69
2100197-100197101.244101.92
3100084-100084101.130101.80
4101461-101461102.521103.20
5100352-100352101.401102.06
6100299-100299101.347102.03
45min199625-99625100.666101.220.52101.50102.060.52
2100482-100482101.532102.38
399748-99748100.790101.63
4101021-101021102.077102.93
5100030-100030101.075101.90
6100144-100144101.191102.04
极限198734-9873499.766100.700.91100.77101.710.91
299810-99810100.853101.87
398662-9866299.693100.70
4101097-101097102.154103.18
599638-99638100.679101.68
699998-99998101.043102.06
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%
119.419821698283981559819998581982870.18
219.459821498308982610.07
单位质量响应值RSD%判断
5063.735051.980.17数据可信
长期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%
5min1100116-100116101.110100.832.71101.11100.832.71
2102751-102751103.771103.77
3101513-101513102.521102.52
4100737-100737101.737101.74
595000-9500095.94395.94
698913-9891399.89599.90
10min1100883-100883101.885101.812.72102.05101.972.72
2103514-103514104.542104.71
3102562-102562103.580103.75
4102128-102128103.142103.31
595871-9587196.82396.98
699870-99870100.862101.03
15min1100299-100299101.295101.402.97101.63101.742.97
2103142-103142104.166104.51
3102283-102283103.299103.64
4101945-101945102.957103.30
594881-9488195.82396.14
699869-99869100.861101.20
20min1100315-100315101.311101.352.66101.82101.862.66
2102576-102576103.595104.12
3102341-102341103.357103.87
4101774-101774102.785103.30
595448-9544896.39696.88
699659-99659100.649101.15
30min1100480-100480101.478101.172.80102.15101.842.79
2102608-102608103.627104.32
3101717-101717102.727103.41
4101983-101983102.996103.68
595023-9502395.96796.61
699230-99230100.215100.89
45min1100127-100127101.121100.982.71101.97101.822.71
2102392-102392103.409104.27
3101352-101352102.358103.22
4101870-101870102.882103.74
595023-9502395.96796.77
699136-99136100.120100.96
极限1100216-100216101.211100.782.91102.22101.792.91
2102643-102643103.662104.70
3100656-100656101.656102.69
4101442-101442102.449103.48
594304-9430495.24096.20
699452-99452100.440101.44
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%
119.419779897743981609758898027978630.24
219.459802097950979850.06
单位质量响应值RSD%判断
5041.895037.790.06数据可信
长期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%
5min1102818-102818104.21095.5813.15104.2195.5813.15
297541-9754198.86298.86
398782-98782100.119100.12
496336-9633697.64097.64
5100898-100898102.264102.26
669459-6945970.39970.40
10min1102839-102839104.231101.552.39104.41101.722.39
299143-99143100.485100.65
399711-99711101.061101.23
496309-9630997.61397.78
5102395-102395103.781103.95
6100792-100792102.157102.27
15min1103377-103377104.777101.903.05105.12102.233.05
298298-9829899.62999.96
399209-99209100.552100.89
496631-9663197.93998.26
5104589-104589106.005106.35
6101120-101120102.489102.78
20min1102505-102505103.893101.062.42104.41101.562.41
297998-9799899.32599.82
399133-99133100.475100.98
496167-9616797.46997.96
5101799-101799103.177103.70
6100681-100681102.044102.50
30min1102185-102185103.569101.112.49104.26101.782.49
298248-9824899.578100.24
398858-98858100.196100.87
495997-9599797.29797.95
5102227-102227103.611104.30
6101030-101030102.398103.03
45min1102906-102906104.299100.882.65105.17101.722.65
297379-9737998.69799.53
398878-98878100.217101.05
495946-9594697.24598.06
5101698-101698103.075103.94
6100380-100380101.739102.54
极限1102109-102109103.492100.622.57104.53101.632.57
297269-9726998.58699.58
398221-9822199.551100.56
495839-9583997.13798.11
5101728-101728103.105104.14
6100512-100512101.873102.84
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%
119.419820098185981159797998352981660.14
219.459812098532983260.30
单位质量响应值RSD%判断
5057.505055.320.04数据可信
长期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%
5min1100770-100770101.80095.354.81101.8095.354.81
294992-9499295.96395.96
395829-9582996.80896.81
494418-9441895.38395.38
586699-8669987.58587.58
693616-9361694.57394.57
10min1100461-100461101.487100.891.97101.66101.041.97
296854-9685497.84498.00
3102120-102120103.163103.32
498141-9814199.14499.30
5100719-100719101.748101.89
6100913-100913101.944102.10
15min1100551-100551101.578100.842.36101.92101.162.36
296664-9666497.65297.97
3102292-102292103.337103.67
4101748-101748102.788103.11
5100475-100475101.502101.82
697178-9717898.17198.50
20min1100125-100125101.148100.851.97101.66101.341.97
296754-9675497.74398.23
3101977-101977103.019103.52
4101550-101550102.588103.08
5100163-100163101.186101.67
698396-9839699.40199.89
30min199784-99784100.804100.092.60101.48100.752.59
296755-9675597.74498.39
3101320-101320102.355103.03
4101559-101559102.597103.26
599898-99898100.919101.57
695151-9515196.12396.78
45min1100191-100191101.215100.921.97102.06101.751.97
296009-9600996.99097.80
3101048-101048102.080102.93
4101413-101413102.449103.29
5100209-100209101.233102.05
6100549-100549101.576102.39
极限199583-99583100.601100.272.09101.61101.262.08
295227-9522796.20097.17
3101028-101028102.060103.08
4100557-100557101.584102.59
599604-99604100.622101.61
699516-99516100.533101.52
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