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%
119.239478194805950629512995223950000.21
219.229503095179951040.12
单位质量响应值RSD%判断
4940.204948.180.12数据可信
供试品溶液-YBA2147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%
5min179234-7923481.86081.823.8181.8681.823.81
276997-7699779.54979.55
377763-7776380.34180.34
475635-7563578.14278.14
582463-8246385.19685.20
683092-8309285.84685.85
10min197110-97110100.329101.991.03100.47102.121.03
298932-98932102.211102.34
399120-99120102.406102.54
4100149-100149103.469103.60
598164-98164101.418101.56
698826-98826102.102102.24
15min197268-97268100.492102.101.20100.80102.411.20
299579-99579102.880103.18
399960-99960103.273103.58
4100049-100049103.365103.67
597922-97922101.168101.48
698178-98178101.432101.75
20min196513-9651399.712101.661.45100.18102.141.44
298536-98536101.802102.28
398816-98816102.092102.57
4100790-100790104.131104.61
597726-97726100.965101.45
697999-97999101.247101.73
30min196438-9643899.635101.311.08100.27101.961.08
298290-98290101.548102.19
398520-98520101.786102.43
499636-99636102.939103.59
597665-97665100.902101.55
697830-97830101.073101.72
45min196325-9632599.518101.341.14100.32102.161.13
298726-98726101.999102.81
398438-98438101.701102.52
499584-99584102.885103.71
597654-97654100.891101.71
697804-97804101.046101.87
极限196069-9606999.253101.081.06100.22102.061.06
298377-98377101.638102.62
398121-98121101.373102.36
499150-99150102.437103.43
597710-97710100.949101.93
697592-97592100.827101.81
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%
119.239524495234956549510095273953010.22
219.229483395007949200.13
单位质量响应值RSD%判断
4955.854938.610.25数据可信
供试品溶液-YBA2147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%
5min180083-8008382.68778.335.4282.6978.345.42
269682-6968271.94871.95
375036-7503677.47677.48
480851-8085183.48083.48
574254-7425476.66876.67
675296-7529677.74477.74
10min1100321-100321103.583101.381.64103.72101.511.64
299779-99779103.023103.14
397188-97188100.348100.48
496430-9643099.56599.70
598501-98501101.704101.83
696913-96913100.064100.19
15min1100322-100322103.584101.311.81103.89101.611.81
2100056-100056103.309103.60
396804-9680499.952100.25
496421-9642199.55699.86
598541-98541101.745102.04
696589-9658999.730100.03
20min1100771-100771104.048101.431.98104.53101.901.98
2100269-100269103.529103.99
397258-97258100.420100.88
496044-9604499.16799.64
598421-98421101.621102.09
696644-9664499.786100.25
30min1100780-100780104.057101.421.82104.71102.051.81
299809-99809103.054103.69
396966-96966100.119100.75
496518-9651899.656100.29
598523-98523101.727102.36
696737-9673799.882100.51
45min1100543-100543103.812101.111.88104.64101.921.87
299657-99657102.897103.71
396805-9680599.953100.75
496217-9621799.346100.15
598079-98079101.268102.07
696265-9626599.395100.19
极限1100236-100236103.495100.971.85104.50101.941.85
299441-99441102.674103.65
396433-9643399.569100.53
496051-9605199.174100.14
598358-98358101.556102.53
696228-9622899.357100.32
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%
119.231896491896371900611894891897081897090.12
219.221885811885431885620.02
单位质量响应值RSD%判断
9865.269810.720.40数据可信
供试品溶液-YBA2319批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166839-6683934.70424.7522.2534.7024.7522.25
237308-3730819.37119.37
347872-4787224.85624.86
450588-5058826.26626.27
543723-4372322.70222.70
639699-3969920.61320.61
10min1189386-18938698.33498.451.3598.3998.491.34
2192558-19255899.981100.01
3187809-18780997.51597.56
4192482-19248299.94199.98
5186129-18612996.64296.68
6189320-18932098.29998.33
15min1194057-194057100.759101.550.52100.98101.750.51
2195515-195515101.516101.71
3195762-195762101.644101.85
4196976-196976102.275102.48
5196182-196182101.862102.06
6194964-194964101.230101.43
20min1193852-193852100.652101.390.47101.04101.760.47
2194879-194879101.186101.55
3195821-195821101.675102.05
4196430-196430101.991102.37
5195728-195728101.627102.00
6194893-194893101.193101.56
30min1193619-193619100.531101.060.51101.09101.600.51
2194285-194285100.877101.41
3195207-195207101.356101.90
4196063-196063101.800102.35
5195074-195074101.287101.82
6193560-193560100.501101.04
45min1192996-192996100.208100.830.51100.93101.540.50
2193913-193913100.684101.39
3194602-194602101.042101.75
4195588-195588101.554102.27
5194769-194769101.129101.84
6193306-193306100.369101.07
极限1192364-19236499.880100.440.48100.77101.320.47
2193449-193449100.443101.32
3194213-194213100.840101.72
4194314-194314100.892101.78
5194014-194014100.737101.61
6192293-19229399.843100.71
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%
119.231887651889561887401888731888661888400.05
219.221872591873321872960.03
单位质量响应值RSD%判断
9820.079744.850.55数据可信
供试品溶液-YBA2319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%
5min126177-2617713.66922.4544.9113.6722.4544.91
229668-2966815.49215.49
352038-5203827.17327.17
469976-6997636.54036.54
557033-5703329.78129.78
623085-2308512.05412.05
10min1193937-193937101.26999.422.46101.2999.462.45
2192552-192552100.546100.57
3183814-18381495.98396.03
4190406-19040699.42599.49
5195749-195749102.215102.26
6185945-18594597.09697.12
15min1197122-197122102.932102.040.89103.12102.240.88
2195206-195206101.932102.12
3196240-196240102.471102.68
4192274-192274100.401100.63
5196599-196599102.659102.88
6195014-195014101.831102.01
20min1196869-196869102.800101.940.89103.16102.310.88
2195206-195206101.932102.29
3196205-196205102.453102.83
4192023-192023100.269100.66
5196102-196102102.399102.79
6194884-194884101.763102.12
30min1196112-196112102.405101.660.85102.94102.210.84
2194671-194671101.652102.19
3196026-196026102.360102.91
4191695-191695100.098100.66
5195412-195412102.039102.60
6194243-194243101.429101.95
45min1195657-195657102.167101.340.88102.87102.050.88
2194047-194047101.326102.03
3195357-195357102.010102.73
4191007-19100799.739100.47
5194891-194891101.767102.50
6193476-193476101.028101.72
极限1195025-195025101.837101.111.00102.71101.990.99
2194174-194174101.393102.26
3194700-194700101.667102.55
4189774-18977499.09599.99
5194210-194210101.411102.31
6193933-193933101.267102.13
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