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%
119.269482094778947659468894838947780.07
219.179415094563943560.31
单位质量响应值RSD%判断
4920.984922.070.02数据可信
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%
5min195663-9566399.28998.581.0499.2998.581.04
293782-9378297.33797.34
394235-9423597.80797.81
496446-96446100.102100.10
594553-9455398.13798.14
695190-9519098.79898.80
10min196098-9609899.74199.910.9199.91100.070.91
296038-9603899.67899.84
395007-9500798.60898.77
497289-97289100.977101.14
595890-9589099.52599.69
697227-97227100.912101.08
15min195685-9568599.31299.920.9299.64100.250.92
296067-9606799.708100.04
395142-9514298.74899.08
496929-96929100.603100.94
596203-9620399.850100.18
697596-97596101.295101.63
20min195913-9591399.54999.781.15100.05100.281.15
296170-9617099.815100.31
394555-9455598.13998.63
496945-96945100.620101.12
595523-9552399.14499.64
697707-97707101.411101.91
30min195559-9555999.18199.450.9699.84100.120.96
295880-9588099.514100.18
394706-9470698.29698.95
496940-96940100.615101.29
595013-9501398.61599.28
696821-96821100.491101.16
45min195483-9548399.10299.250.9299.93100.080.92
295428-9542899.04599.87
394334-9433497.91098.73
496370-96370100.023100.86
595332-9533298.94699.77
696828-96828100.498101.34
极限194837-9483798.43298.660.7199.4399.650.71
294843-9484398.43899.43
394355-9435597.93298.91
496332-9633299.984100.99
594876-9487698.47299.46
695070-9507098.67499.68
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%
119.269447894490942819441394564944450.12
219.179410694049940780.05
单位质量响应值RSD%判断
4903.694907.560.06数据可信
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%
5min185699-8569989.23698.144.7589.2498.144.75
297579-97579101.606101.61
393596-9359697.45997.46
497581-97581101.608101.61
594775-9477598.68698.69
696251-96251100.223100.22
10min195028-9502898.950100.991.5199.10101.161.52
298803-98803102.880103.05
396280-96280100.253100.42
498564-98564102.632102.80
596231-96231100.202100.37
697033-97033101.037101.20
15min195478-9547899.418100.941.4699.73101.271.46
298817-98817102.895103.24
395563-9556399.50799.84
498361-98361102.420102.76
596348-96348100.324100.66
697069-97069101.075101.41
20min195722-9572299.672100.831.23100.15101.331.23
298199-98199102.252102.76
395979-9597999.940100.44
498414-98414102.475102.99
595999-9599999.961100.46
696688-96688100.678101.18
30min195375-9537599.311100.681.1899.96101.341.19
298194-98194102.246102.93
395992-9599299.953100.62
497825-97825101.862102.54
595850-9585099.806100.47
696874-96874100.872101.54
45min194902-9490298.818100.221.2599.63101.061.25
297378-97378101.397102.25
395690-9569099.639100.47
497990-97990102.034102.89
595392-9539299.329100.16
696155-96155100.123100.96
极限195293-9529399.22699.861.80100.20100.871.79
298169-98169102.220103.24
395216-9521699.145100.14
497519-97519101.543102.57
593422-9342297.27798.27
695821-9582199.775100.78
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%
119.269406494192942879437294299942430.13
219.179362594016938200.30
单位质量响应值RSD%判断
4893.204894.110.02数据可信
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%
5min197879-97879102.16898.942.81102.1798.932.81
294713-9471398.86398.86
396583-96583100.815100.81
496282-96282100.501100.50
591974-9197496.00496.00
691264-9126495.26395.26
10min199213-99213103.56099.943.18103.73100.103.18
296332-96332100.553100.72
396931-96931101.178101.35
497582-97582101.858102.03
593566-9356697.66697.83
690819-9081994.79894.96
15min199462-99462103.820100.122.97104.16100.462.97
296289-96289100.508100.84
396854-96854101.098101.43
497842-97842102.129102.47
592903-9290396.97497.30
692170-9217096.20996.53
20min198632-98632102.95499.742.82103.47100.242.82
295803-95803100.001100.50
396697-96697100.934101.44
497591-97591101.867102.37
592683-9268396.74497.23
691940-9194095.96896.45
30min198909-98909103.24399.602.89103.93100.262.89
295646-9564699.837100.50
396833-96833101.076101.75
496834-96834101.077101.75
592469-9246996.52197.17
691827-9182795.85196.49
45min198111-98111102.41099.163.22103.2799.993.21
295556-9555699.743100.58
396575-96575100.807101.65
497179-97179101.437102.28
590400-9040094.36195.17
692135-9213596.17296.97
极限198473-98473102.788100.082.57103.82101.072.56
295556-9555699.743100.74
396244-96244100.461101.47
497043-97043101.295102.31
596672-96672100.908101.87
691275-9127595.27496.23
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%
119.269427594466939119394194325941840.27
219.179393193752938420.14
单位质量响应值RSD%判断
4890.134895.250.08数据可信
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%
5min191169-9116995.18295.072.3295.1895.072.32
291445-9144595.47095.47
389280-8928093.21093.21
494918-9491899.09699.10
589162-8916293.08793.09
690407-9040794.38794.39
10min192542-9254296.61697.753.3696.7797.913.36
295144-9514499.33299.49
390608-9060894.59794.75
497510-97510101.802101.97
589754-8975493.70593.86
696225-96225100.461100.62
15min192555-9255596.62998.083.5996.9598.403.59
297109-97109101.384101.71
390525-9052594.51094.82
497061-97061101.334101.67
589877-8987793.83394.14
696533-96533100.782101.11
20min192655-9265596.73497.953.7697.2198.433.75
295853-95853100.073100.57
390314-9031494.29094.76
497349-97349101.634102.14
589418-8941893.35493.82
697326-97326101.610102.10
30min192944-9294497.03597.673.6197.6898.323.61
294762-9476298.93499.59
389879-8987993.83694.46
497182-97182101.460102.13
589521-8952193.46294.09
697047-97047101.319101.98
45min193692-9369297.81697.523.4598.6298.333.45
294953-9495399.13399.96
389575-8957593.51894.30
496589-96589100.841101.68
589378-8937893.31294.09
696279-96279100.517101.35
极限192636-9263696.71497.243.5497.6898.213.53
294515-9451598.67699.67
389807-8980793.76094.70
496568-96568100.819101.83
588872-8887292.78493.72
696437-96437100.682101.68
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