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500
标示量(mg)20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%
114.553396233388803386063385283387763388830.13
214.583390693389613390150.03
单位质量响应值RSD%判断
23290.9323252.060.12数据可信
供试品溶液-2025011321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%
5min1170625-17062542.54543.124.5942.5543.124.58
2188184-18818446.92446.92
3164732-16473241.07641.08
4170428-17042842.49642.50
5171903-17190342.86442.86
6171645-17164542.80042.80
10min1343651-34365185.69086.882.7185.7686.952.71
2364983-36498391.00991.09
3339150-33915084.56784.64
4342151-34215185.31685.39
5353089-35308988.04388.11
6347452-34745286.63786.71
15min1388388-38838896.84599.132.9197.0699.352.91
2413517-413517103.111103.34
3381683-38168395.17395.38
4402635-402635100.397100.61
5395056-39505698.50898.73
6404115-404115100.766100.98
20min1383783-38378395.69799.383.4996.0799.763.48
2414920-414920103.461103.86
3381842-38184295.21395.58
4409177-409177102.029102.41
5394653-39465398.40798.79
6406835-406835101.445101.83
30min1386573-38657396.39298.912.9596.9399.462.96
2412684-412684102.903103.48
3381015-38101595.00695.53
4401982-401982100.235100.78
5394317-39431798.32398.87
6403540-403540100.623101.18
45min1388025-38802596.75498.933.0297.4599.643.02
2412617-412617102.886103.63
3379658-37965894.66895.35
4402962-402962100.479101.20
5393557-39355798.13498.84
6403628-403628100.645101.37
极限1384582-38458295.896100.544.4296.75101.424.40
2431867-431867107.686108.60
3385846-38584696.21197.05
4401484-401484100.110101.00
5413686-413686103.153104.03
6401805-401805100.190101.08
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500
标示量(mg)20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%
114.553385293384783389973389943386753387350.08
214.583398963400743399850.04
单位质量响应值RSD%判断
23280.7623318.590.12数据可信
供试品溶液-2025011321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%
5min1173803-17380343.28639.979.1643.2939.979.16
2154056-15405638.36838.37
3136240-13624033.93033.93
4167741-16774141.77641.78
5174692-17469243.50743.51
6156333-15633338.93538.93
10min1360463-36046389.77385.145.9089.8585.215.91
2342674-34267485.34385.41
3303945-30394575.69775.75
4350888-35088887.38887.46
5354435-35443588.27288.34
6338816-33881684.38284.45
15min1399732-39973299.55398.361.6099.7798.571.61
2402274-402274100.186100.39
3384897-38489795.85896.04
4396971-39697198.86599.08
5395080-39508098.39498.61
6390766-39076697.32097.53
20min1400664-40066499.78598.441.74100.1798.811.75
2402952-402952100.355100.73
3386243-38624396.19496.54
4396981-39698198.86899.25
5397143-39714398.90899.29
6387539-38753996.51696.88
30min1400487-40048799.74198.391.53100.2998.931.54
2401629-401629100.025100.57
3386433-38643396.24196.74
4396559-39655998.76399.31
5395891-39589198.59699.14
6389417-38941796.98497.51
45min1401265-40126599.93598.381.60100.6599.081.60
2401265-40126599.935100.64
3384760-38476095.82496.49
4395912-39591298.60299.31
5395613-39561398.52799.24
6391347-39134797.46598.15
极限1400509-40050999.74698.141.68100.6399.011.69
2400231-40023199.677100.55
3383993-38399395.63396.46
4395452-39545298.48799.36
5395925-39592598.60599.48
6388361-38836196.72197.57
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