盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1342122732124182124352121342119312122380.10
2342133112133962133540.03
单位质量响应值RSD%判断
6242.296275.120.38数据可信
供试品溶液-2022060501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%
5min18041-80418.5974.53116.158.604.53116.15
26129-61296.5526.55
3-0.0000.00
4-0.0000.00
511246-1124612.02312.02
6-0.0000.00
10min180675-8067586.24979.648.0186.3079.678.00
267649-6764972.32372.36
380708-8070886.28586.28
477457-7745782.80982.81
572379-7237977.38077.45
668106-6810672.81272.81
15min1105795-105795113.105113.433.50113.63113.903.51
2101756-101756108.787109.23
3109082-109082116.619117.10
4106142-106142113.476113.94
5111366-111366119.061119.56
6102478-102478109.559109.96
20min1116995-116995125.079124.853.18126.23125.953.19
2111376-111376119.072120.11
3120051-120051128.346129.47
4118855-118855127.068128.16
5120196-120196128.501129.66
6113215-113215121.038122.05
30min1113300-113300121.129124.573.54122.98126.363.53
2112487-112487120.260121.96
3120447-120447128.770130.61
4118383-118383126.563128.36
5121607-121607130.010131.88
6112885-112885120.685122.37
45min1116417-116417124.461128.503.09126.98130.983.08
2116511-116511124.562126.93
3124035-124035132.605135.16
4123881-123881132.441134.94
5122677-122677131.154133.75
6117650-117650125.779128.14
60min1120181-120181128.485132.213.16131.70135.403.14
2118060-118060126.218129.28
3127064-127064135.844139.14
4123152-123152131.661134.90
5127706-127706136.530139.85
6125812-125812134.505137.56
极限1124425-124425133.022137.302.58136.95141.242.58
2124490-124490133.092136.86
3131502-131502140.588144.64
4131080-131080140.137144.10
5131003-131003140.055144.14
6128081-128081136.931140.73
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1342132922129772129152130332128832130200.08
2342130502130932130720.02
单位质量响应值RSD%判断
6265.296266.820.02数据可信
供试品溶液-2022060501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%
5min1-0.0005.30152.990.005.30152.97
22908-29083.1053.11
33603-36033.8473.85
43160-31603.3743.37
5-0.0000.00
620134-2013421.50021.50
10min179143-7914384.51279.845.5284.5179.875.48
274028-7402879.05079.07
374255-7425579.29279.31
471464-7146476.31276.33
580070-8007085.50285.50
669653-6965374.37874.50
15min1108612-108612115.980112.082.42116.45112.552.41
2103919-103919110.968111.42
3102727-102727109.696110.16
4103810-103810110.852111.29
5107714-107714115.021115.50
6102984-102984109.970110.50
20min1119178-119178127.262122.942.64128.38124.042.64
2114295-114295122.048123.12
3110815-110815118.332119.40
4113688-113688121.400122.46
5114821-114821122.610123.72
6117988-117988125.992127.14
30min1120387-120387128.553124.991.57130.37126.771.56
2115361-115361123.187124.94
3117225-117225125.177126.91
4116260-116260124.147125.88
5117421-117421125.386127.18
6115637-115637123.481125.32
45min1126018-126018134.566128.932.61137.10131.402.59
2122347-122347130.646133.08
3117804-117804125.795128.22
4117542-117542125.516127.94
5120458-120458128.629131.12
6120245-120245128.402130.93
60min1127013-127013135.629131.571.75138.91134.761.75
2123077-123077131.426134.59
3121771-121771130.031133.15
4120748-120748128.939132.06
5122895-122895131.232134.44
6123764-123764132.160135.40
极限1131160-131160140.057138.811.59144.09142.731.55
2133370-133370142.417146.31
3128534-128534137.253141.10
4129298-129298138.069141.91
5129989-129989138.807142.74
6127577-127577136.231140.21
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