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%
119.239406693635939169409394040939500.21
219.229390294126940140.17
单位质量响应值RSD%判断
4885.604891.470.09数据可信
供试品溶液-YAB2158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%
5min178508-7850882.03489.765.2982.0389.765.29
285336-8533689.16889.17
392061-9206196.19596.20
485783-8578389.63689.64
588880-8888092.87292.87
684820-8482088.62988.63
10min196520-96520100.855102.673.78100.99102.823.78
296641-96641100.981101.13
3105694-105694110.441110.60
495725-95725100.024100.17
597066-97066101.425101.58
697924-97924102.322102.47
15min196417-96417100.747102.653.94101.05102.973.94
296759-96759101.104101.42
3106041-106041110.803111.15
495761-95761100.062100.38
597065-97065101.424101.75
697395-97395101.769102.09
20min196092-96092100.407102.663.72100.88103.153.72
297046-97046101.404101.89
3105558-105558110.299110.83
495861-95861100.166100.65
597609-97609101.993102.49
697324-97324101.695102.18
30min196236-96236100.558102.293.62101.20102.963.62
296489-96489100.822101.48
3105046-105046109.764110.48
495695-9569599.993100.64
596916-96916101.268101.93
697001-97001101.357102.01
45min195776-95776100.077102.093.73100.88102.923.73
296227-96227100.549101.37
3105039-105039109.756110.65
495437-9543799.723100.54
596664-96664101.005101.84
697047-97047101.405102.23
极限195810-95810100.113101.873.62101.09102.883.62
296074-96074100.389101.38
3104578-104578109.275110.35
495182-9518299.457100.44
596291-96291100.615101.62
697020-97020101.377102.37
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%
119.239379693851940319385593850938770.10
219.229363293695936640.05
单位质量响应值RSD%判断
4881.804873.260.13数据可信
供试品溶液-YAB2158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%
5min190335-9033594.60592.324.4094.6092.324.40
287978-8797892.13792.14
384461-8446188.45388.45
494028-9402898.47298.47
588636-8863692.82692.83
683481-8348187.42787.43
10min196887-96887101.467101.640.43101.62101.790.43
297364-97364101.966102.12
396990-96990101.574101.72
496599-96599101.165101.33
597721-97721102.340102.49
696761-96761101.335101.48
15min197164-97164101.757101.700.63102.08102.020.63
297918-97918102.546102.87
396758-96758101.332101.65
496447-96447101.006101.34
597737-97737102.357102.68
696633-96633101.201101.52
20min196758-96758101.332101.430.59101.83101.920.58
297164-97164101.757102.25
396583-96583101.148101.63
496366-96366100.921101.42
597838-97838102.463102.96
696415-96415100.972101.46
30min196993-96993101.578101.440.50102.24102.100.50
297214-97214101.809102.47
396644-96644101.212101.87
496769-96769101.343102.01
597447-97447102.053102.72
696082-96082100.624101.28
45min196591-96591101.157101.270.65101.99102.110.65
297035-97035101.622102.46
396813-96813101.389102.21
495864-95864100.395101.23
597663-97663102.279103.12
696256-96256100.806101.63
极限195930-95930100.464100.840.55101.47101.840.55
296614-96614101.181102.18
396113-96113100.656101.65
495848-95848100.379101.38
597211-97211101.806102.81
696017-96017100.555101.54
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%
119.239391693956939459386293767938890.09
219.229369393672936820.02
单位质量响应值RSD%判断
4882.424874.190.12数据可信
供试品溶液-YAB2158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%
5min180116-8011683.88987.766.3083.8987.766.30
276003-7600379.58379.58
387203-8720391.31091.31
481982-8198285.84385.84
588503-8850392.67192.67
689058-8905893.25393.25
10min196887-96887101.450101.730.86101.59101.880.86
296947-96947101.513101.65
396708-96708101.263101.42
496208-96208100.739100.88
597636-97636102.235102.39
698558-98558103.200103.36
15min196751-96751101.308101.720.74101.62102.040.74
297251-97251101.832102.13
396614-96614101.165101.49
496358-96358100.896101.21
597677-97677102.278102.60
698241-98241102.868103.20
20min197028-97028101.598101.650.67102.08102.140.67
296879-96879101.442101.91
397140-97140101.715102.20
496008-96008100.530101.01
597562-97562102.157102.65
697877-97877102.487102.99
30min196888-96888101.451101.290.64102.10101.950.64
296865-96865101.427102.07
396256-96256100.790101.45
495761-95761100.271100.92
597321-97321101.905102.57
697312-97312101.895102.57
45min196334-96334100.871100.840.60101.69101.670.61
296503-96503101.048101.86
395822-95822100.335101.16
495448-9544899.944100.76
596946-96946101.512102.35
696801-96801101.360102.20
极限195978-95978100.499100.820.81101.48101.810.81
296607-96607101.157102.14
395664-95664100.170101.16
495417-9541799.911100.89
596481-96481101.025102.03
697559-97559102.154103.16
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%
119.239373093715936949380993718937330.05
219.229368593387935360.23
单位质量响应值RSD%判断
4874.314866.600.12数据可信
供试品溶液-YAB2158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%
5min185636-8563689.81490.046.8989.8190.046.89
289249-8924993.60393.60
384753-8475388.88888.89
488681-8868193.00893.01
574986-7498678.64478.64
691827-9182796.30796.31
10min198062-98062102.846102.211.64103.00102.361.65
298644-98644103.457103.61
399002-99002103.832103.98
496448-96448101.154101.31
594738-9473899.36099.49
697861-97861102.635102.80
15min197701-97701102.468101.841.81102.79102.161.81
298506-98506103.312103.64
399351-99351104.198104.52
495857-95857100.534100.86
594614-9461499.23099.53
696583-96583101.295101.63
20min197428-97428102.181101.801.63102.67102.281.63
298563-98563103.372103.87
398745-98745103.563104.06
495985-95985100.668101.16
594612-9461299.22899.69
697028-97028101.762102.26
30min197475-97475102.231101.561.62102.89102.221.62
298199-98199102.990103.66
398525-98525103.332104.00
495834-95834100.510101.17
594386-9438698.99199.62
696603-96603101.316101.99
45min197062-97062101.798101.331.51102.63102.161.51
297706-97706102.473103.32
398083-98083102.868103.71
495971-95971100.653101.48
594057-9405798.64699.44
696813-96813101.536102.38
极限197204-97204101.946101.211.57102.95102.211.57
297655-97655102.419103.43
398191-98191102.982103.99
495582-95582100.245101.24
594081-9408198.67199.63
696292-96292100.990102.00
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