美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.071999911994171989341990961992331993340.21
219.071998352000901999620.10
单位质量响应值RSD%判断
10452.7510485.680.23数据可信
供试品溶液-12460835批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122940-2294011.48212.627.0911.4812.627.09
227238-2723813.63313.63
327110-2711013.56913.57
425216-2521612.62112.62
525268-2526812.64712.65
623460-2346011.74211.74
10min135971-3597118.00418.351.9818.1318.492.01
237619-3761918.82918.98
337078-3707818.55918.71
437190-3719018.61518.75
536007-3600718.02218.16
636084-3608418.06118.19
15min140477-4047720.26020.581.9920.5920.922.00
241864-4186420.95421.31
341209-4120920.62620.98
442294-4229421.16921.52
540491-4049120.26720.61
640347-4034720.19520.53
20min141855-4185520.95021.261.0521.5021.841.09
243026-4302621.53622.13
342943-4294321.49422.08
442452-4245221.24821.83
542218-4221821.13121.70
642383-4238321.21421.77
30min143762-4376221.90422.262.4122.6923.072.37
245521-4552122.78523.62
343152-4315221.59922.42
445975-4597523.01223.83
544340-4434022.19322.99
644136-4413622.09122.88
45min146539-4653923.29422.982.0624.3224.041.99
246501-4650123.27524.36
347184-4718423.61724.68
444925-4492522.48623.56
545396-4539622.72223.77
644980-4498022.51423.55
60min147406-4740623.72823.091.5525.0224.401.42
246063-4606323.05624.40
345466-4546622.75724.08
446042-4604223.04524.37
545483-4548322.76524.07
646287-4628723.16824.45
极限145884-4588422.96623.321.3824.5224.881.36
247726-4772623.88825.49
346667-4666723.35824.94
446349-4634923.19924.78
546170-4617023.10924.66
646697-4669723.37324.92
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.072000681996241997891990011998401996640.21
219.071990591988971989780.06
单位质量响应值RSD%判断
10470.0610434.080.25数据可信
供试品溶液-12460835批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123094-2309411.57812.358.6811.5812.358.68
222555-2255511.30811.31
327321-2732113.69713.70
422550-2255011.30511.31
526379-2637913.22513.23
625865-2586512.96712.97
10min134630-3463017.36217.812.4417.4917.942.48
235268-3526817.68217.81
337136-3713618.61818.77
435000-3500017.54717.67
535603-3560317.85018.00
635449-3544917.77217.92
15min138737-3873719.42119.703.2619.7420.043.28
238760-3876019.43219.75
341509-4150920.81021.17
438044-3804419.07319.39
538652-3865219.37819.72
640124-4012420.11620.46
20min141654-4165420.88320.972.0721.4221.522.09
241715-4171520.91421.45
342204-4220421.15921.75
440495-4049520.30220.83
541739-4173920.92621.49
643154-4315421.63522.20
30min141912-4191221.01321.233.1221.7822.013.10
241583-4158320.84821.62
343299-4329921.70822.53
440251-4025120.18020.94
543518-4351821.81822.61
643475-4347521.79622.60
45min143814-4381421.96621.971.4022.9722.991.27
243524-4352421.82122.82
342918-4291821.51722.58
444586-4458622.35323.34
544403-4440322.26123.30
643629-4362921.87322.92
60min145135-4513522.62822.632.1523.8823.902.12
245340-4534022.73123.98
345113-4511322.61723.92
443328-4332821.72222.95
545888-4588823.00624.29
646042-4604223.08324.37
极限146857-4685723.49222.572.4624.9924.082.22
244585-4458522.35323.85
343683-4368321.90023.46
445407-4540722.76524.24
545234-4523422.67824.22
644288-4428822.20423.75
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