依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.131750111748471749451748181748451748930.05
210.251769611774711772160.21
单位质量响应值RSD%判断
17264.8617289.370.11数据可信
供试品溶液-2024012921批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1111516-11151658.09157.327.7658.0957.327.76
295489-9548949.74249.74
3107709-10770956.10856.11
4120736-12073662.89462.89
5109332-10933256.95356.95
6115490-11549060.16160.16
10min1166008-16600886.47788.062.5286.8088.382.52
2167310-16731087.15587.43
3174832-17483291.07491.39
4172800-17280090.01590.36
5163565-16356585.20485.52
6169754-16975488.42888.76
15min1172186-17218689.69591.101.7090.5091.911.70
2171667-17166789.42590.19
3179494-17949493.50294.32
4177003-17700392.20593.05
5174588-17458890.94691.74
6174342-17434290.81891.64
20min1169507-16950788.30091.442.6789.6092.752.66
2172708-17270889.96791.22
3182865-18286595.25896.60
4178077-17807792.76494.13
5173550-17355090.40691.70
6176448-17644891.91593.25
30min1172004-17200489.60091.881.7591.3993.701.75
2176792-17679292.09593.85
3179603-17960393.55995.43
4179559-17955993.53695.41
5173688-17368890.47892.27
6176635-17663592.01393.85
45min1178895-17889593.19092.760.6895.4895.090.68
2178027-17802792.73895.01
3179262-17926293.38195.77
4178944-17894493.21695.61
5176406-17640691.89494.19
6176834-17683492.11694.47
60min1170025-17002588.57092.692.4591.3895.542.42
2178384-17838492.92495.71
3179591-17959193.55396.46
4182996-18299695.32698.24
5177051-17705192.23095.04
6179613-17961393.56496.43
极限1183062-18306295.36197.531.1598.66100.901.15
2188257-18825798.067101.37
3188113-18811397.992101.42
4189132-18913298.523101.97
5187277-18727797.556100.88
6187537-18753797.692101.08
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.954235624233284238354234674232864234960.06
211.054280564289334284940.15
单位质量响应值RSD%判断
38675.4338777.740.19数据可信
供试品溶液-2024012921批-辛伐他汀-pH7.0(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1286656-28665666.28565.547.7466.2965.557.74
2246398-24639856.97656.98
3276377-27637763.90963.91
4310598-31059871.82271.82
5281943-28194365.19665.20
6298740-29874069.08069.08
10min1402983-40298393.18594.942.1593.5595.312.15
2410691-41069194.96795.28
3420993-42099397.34997.70
4418777-41877796.83797.24
5398255-39825592.09192.45
6411866-41186695.23995.62
15min1412480-41248095.38196.501.2496.2797.391.25
2412286-41228695.33696.18
3424301-42430198.11499.01
4422892-42289297.78898.73
5416379-41637996.28297.16
6415528-41552896.08597.00
20min1402992-40299293.18796.032.3094.6097.462.29
2409747-40974794.74996.12
3428614-42861499.111100.55
4422598-42259897.72099.20
5409656-40965694.72896.14
6418082-41808296.67698.12
30min1405776-40577693.83095.521.4995.7697.481.50
2412353-41235395.35197.25
3417099-41709996.44998.44
4422319-42231997.65699.68
5407287-40728794.18096.11
6413728-41372895.66997.65
45min1415515-41551596.08295.990.6198.5498.480.62
2415633-41563396.11098.54
3417183-41718396.46899.00
4418127-41812796.68699.25
5411894-41189495.24597.70
6412339-41233995.34897.86
60min1398509-39850992.15095.571.9895.1498.601.95
2416449-41644996.29899.26
3414567-41456795.86398.93
4422869-42286997.783100.89
5411360-41136095.12298.11
6416023-41602396.20099.24
极限1410877-41087795.01096.420.8698.5199.980.86
2419278-41927896.953100.45
3416089-41608996.21599.81
4421395-42139597.442101.09
5416826-41682696.38699.90
6417404-41740496.519100.10
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