氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.576753846760606759386762206760116759230.05
214.716759806768596764200.10
单位质量响应值RSD%判断
46391.4245983.680.63数据可信
供试品溶液-G031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%
5min1193669-19366924.33221.2034.9324.3321.2034.94
2101426-10142612.74312.74
3211082-21108226.52026.52
10min1388582-38858248.82046.8314.2648.8646.8714.27
2313498-31349839.38739.41
3416163-41616352.28652.33
15min1543688-54368868.30767.705.3768.4367.815.39
2507819-50781963.80163.89
3565055-56505570.99271.12
20min1683850-68385085.91784.331.8486.1584.551.86
2659280-65928082.83083.02
3670465-67046584.23584.49
30min1804669-804669101.096100.480.56101.48100.850.58
2795996-795996100.007100.34
3798548-798548100.327100.72
45min1810614-810614101.843101.571.06102.39102.101.08
2799057-799057100.391100.89
3815629-815629102.473103.03
60min1809795-809795101.740101.480.86102.46102.180.89
2799929-799929100.501101.17
3813325-813325102.184102.91
极限1812129-812129102.034101.760.88102.92102.630.91
2802040-802040100.766101.60
3815668-815668102.478103.38
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.573402943397613394933396623402293398880.11
214.713395083389973392520.11
单位质量响应值RSD%判断
23327.9323062.680.81数据可信
供试品溶液-G246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%
5min1133045-13304533.28533.2712.1133.2833.2712.12
2116848-11684829.23329.23
3149049-14904937.28937.29
10min1250311-25031162.62261.7812.0062.6861.8312.00
2215758-21575853.97854.03
3274724-27472468.73068.79
15min1337093-33709384.33382.075.5984.4982.235.60
2306951-30695176.79276.93
3340100-34010085.08585.26
20min1384461-38446196.18495.543.0496.4895.843.05
2369251-36925192.37892.65
3391985-39198598.06698.38
30min1403443-403443100.933100.950.28101.39101.410.31
2402462-402462100.687101.11
3404687-404687101.244101.73
45min1404412-404412101.175101.160.02101.80101.780.03
2404341-404341101.157101.75
3404318-404318101.151101.80
60min1403050-403050100.834101.040.25101.63101.830.27
2403602-403602100.972101.73
3404976-404976101.316102.14
极限1403424-403424100.928100.920.11101.89101.880.14
2402947-402947100.808101.73
3403792-403792101.020102.01
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.576770506776816786116770366769226774600.11
214.716769926774316772120.05
单位质量响应值RSD%判断
46496.9146037.530.71数据可信
供试品溶液-G031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%
5min199538-9953812.48417.2330.8512.4817.2330.86
2183133-18313322.96922.97
3129395-12939516.22916.23
10min1316457-31645739.69144.6712.0939.7144.7012.10
2401889-40188950.40650.44
3350124-35012443.91343.94
15min1511493-51149364.15266.444.1064.2466.544.12
2553724-55372469.44969.57
3523863-52386365.70465.80
20min1650716-65071681.61483.412.0881.8183.622.10
2678281-67828185.07185.31
3666034-66603483.53583.74
30min1806907-806907101.204100.720.44101.53101.070.42
2801958-801958100.583100.96
3800260-800260100.370100.72
45min1812229-812229101.871101.190.64102.37101.710.62
2806069-806069101.098101.65
3802108-802108100.602101.12
60min1811639-811639101.797101.070.70102.47101.770.69
2805522-805522101.030101.75
3800479-800479100.397101.08
极限1811638-811638101.797100.980.75102.63101.830.73
2803745-803745100.807101.69
3799907-799907100.326101.18
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.573401963404413406233401913397803402460.10
214.713396523393003394760.08
单位质量响应值RSD%判断
23352.5123077.910.84数据可信
供试品溶液-G246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%
5min1121295-12129530.31930.381.1930.3230.381.19
2123082-12308230.76630.77
3120240-12024030.05630.06
10min1237577-23757759.38660.052.1159.4460.102.11
2246074-24607461.51061.56
3237055-23705559.25559.31
15min1317997-31799779.48882.202.9979.6482.352.99
2337126-33712684.26984.42
3331451-33145182.85183.00
20min1369977-36997792.48195.953.1592.7696.243.15
2391827-39182797.94398.24
3389781-38978197.43197.72
30min1398187-39818799.532101.021.4899.97101.471.48
2404091-404091101.008101.47
3410094-410094102.509102.96
45min1400998-400998100.235101.351.27100.84101.971.27
2404359-404359101.075101.70
3411045-411045102.746103.37
60min1400420-400420100.091101.171.14100.86101.961.15
2404182-404182101.031101.83
3409600-409600102.385103.18
极限1399990-39999099.983100.991.18100.92101.941.17
2402839-402839100.695101.66
3409224-409224102.291103.25
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