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%
119.571968821969141967041967591968311968180.05
219.671962971962481962720.02
单位质量响应值RSD%判断
10057.139978.240.56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%
5min196978-9697898.90198.861.9798.9098.861.97
297438-9743899.37099.37
394724-9472496.60296.60
494974-9497496.85796.86
597613-9761399.54899.55
699888-99888101.868101.87
10min197471-9747199.40499.312.0199.5799.482.01
298253-98253100.201100.37
395027-9502796.91197.07
495316-9531697.20697.37
598013-9801399.956100.12
6100213-100213102.200102.37
15min196896-9689698.81798.661.9999.1598.991.99
297480-9748099.41399.75
394413-9441396.28596.61
494717-9471796.59596.92
597369-9736999.30099.63
699562-99562101.536101.88
20min196166-9616698.07398.042.0198.5798.542.01
296836-9683698.75699.25
393746-9374695.60596.09
494221-9422196.08996.57
596829-9682998.74999.25
699007-99007100.970101.48
30min195575-9557597.47097.361.9798.1398.021.97
296354-9635498.26498.93
393195-9319595.04395.69
493466-9346695.31995.96
596035-9603597.93998.60
698172-98172100.118100.80
45min195002-9500296.88696.751.9997.7197.571.99
295489-9548997.38298.21
392747-9274794.58695.39
492711-9271194.54995.35
595626-9562697.52298.35
697621-9762199.557100.40
极限194411-9441196.28396.222.1897.2797.212.18
295058-9505896.94397.93
392025-9202593.85094.81
492147-9214793.97494.94
594966-9496696.84997.84
697505-9750599.438100.45
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%
119.571964071968401963511965211966231965480.10
219.671967951966981967460.04
单位质量响应值RSD%判断
10043.3310002.340.29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%
5min194927-9492796.75896.661.0596.7696.661.05
293549-9354995.35495.35
393699-9369995.50795.51
495303-9530397.14297.14
595576-9557697.42097.42
695939-9593997.79097.79
10min196124-9612497.97897.691.1298.1497.851.12
294428-9442896.25096.41
394590-9459096.41596.57
496443-9644398.30498.47
596551-9655198.41498.58
696916-9691698.78698.95
15min194343-9434396.16397.201.3296.4997.521.31
294153-9415395.96996.29
394194-9419496.01196.33
496339-9633998.19898.52
596300-9630098.15898.48
696813-9681398.68199.01
20min195757-9575797.60497.271.1298.0997.761.12
294169-9416995.98696.46
394043-9404395.85796.34
496206-9620698.06298.55
595877-9587797.72798.22
696528-9652898.39098.88
30min195550-9555097.39397.011.2198.0497.661.21
293665-9366595.47296.11
393807-9380795.61796.26
495827-9582797.67698.33
595905-9590597.75598.41
696314-9631498.17298.83
45min195569-9556997.41397.071.2098.2297.881.20
293828-9382895.63896.44
393786-9378695.59596.39
495935-9593597.78698.60
595789-9578997.63798.45
696471-9647198.33299.15
极限195470-9547097.31296.701.3598.2897.671.35
293144-9314494.94195.90
393342-9334295.14396.10
495551-9555197.39498.37
595670-9567097.51698.49
696043-9604397.89698.88
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%
119.571965451965551962641964441965431964700.07
219.671964341964471964400.01
单位质量响应值RSD%判断
10039.359986.780.38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%
5min196863-9686398.82897.062.1498.8397.062.14
293480-9348095.37795.38
394916-9491696.84296.84
498152-98152100.143100.14
594526-9452696.44496.44
692819-9281994.70294.70
10min198058-98058100.04798.062.24100.2198.222.24
293630-9363095.53095.69
395521-9552197.45997.62
499243-99243101.257101.42
595798-9579897.74297.90
694394-9439496.30996.47
15min198014-98014100.00398.032.13100.3398.362.13
293944-9394495.85096.17
395984-9598497.93198.26
498939-98939100.946101.28
595539-9553997.47797.80
694065-9406595.97396.29
20min197804-9780499.78897.932.10100.2998.422.11
293928-9392895.83496.31
395793-9579397.73798.22
498986-98986100.994101.50
595078-9507897.00797.49
694292-9429296.20596.68
30min197566-9756699.54597.772.18100.2198.422.18
293304-9330495.19795.83
395483-9548397.42098.07
498963-98963100.971101.64
595208-9520897.14097.79
694418-9441896.33496.97
45min197345-9734599.32097.582.12100.1598.402.12
293391-9339195.28696.08
395457-9545797.39498.21
498695-98695100.697101.54
594897-9489796.82297.63
694055-9405595.96396.76
极限197105-9710599.07597.272.08100.0798.252.08
293170-9317095.06096.02
395016-9501696.94497.92
498268-98268100.262101.27
594815-9481596.73997.71
693654-9365495.55496.51
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%
119.571962611964041965881964771965511964560.07
219.671961101957041959070.15
单位质量响应值RSD%判断
10038.639959.680.56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%
5min193866-9386695.90498.852.9195.9098.852.91
299513-99513101.674101.67
3100560-100560102.744102.74
494359-9435996.40896.41
594962-9496297.02497.02
697242-9724299.35499.35
10min195274-9527497.343100.122.6897.50100.282.68
2100423-100423102.604102.77
3101621-101621103.828104.00
495548-9554897.62397.78
596673-9667398.77298.93
698416-98416100.553100.72
15min195084-9508497.14999.932.7097.47100.272.70
2100241-100241102.418102.76
3101468-101468103.672104.02
495340-9534097.41097.73
596524-9652498.62098.95
698207-98207100.340100.67
20min194886-9488696.94799.862.7897.43100.362.78
2100041-100041102.214102.72
3101577-101577103.783104.30
495192-9519297.25997.74
596394-9639498.48798.98
698334-98334100.469100.97
30min194632-9463296.68799.722.8697.33100.382.86
2100529-100529102.712103.39
3101089-101089103.284103.97
494894-9489496.95597.60
596335-9633598.42799.08
698106-98106100.237100.90
45min194538-9453896.59199.392.7097.40100.222.70
299607-99607101.770102.62
3100924-100924103.116103.98
494796-9479696.85597.66
595962-9596298.04698.86
697851-9785199.976100.81
极限194423-9442396.47499.122.7197.44100.112.71
299302-99302101.459102.48
3100748-100748102.936103.97
494411-9441196.46197.43
595737-9573797.81698.80
697430-9743099.546100.55
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