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%
110.131744861742011746291743201742061743680.11
210.251755611752961754280.11
单位质量响应值RSD%判断
17213.0317114.930.41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%
5min161622-6162232.31238.6218.0332.3138.6218.03
294609-9460949.60949.61
384591-8459144.35644.36
472447-7244737.98837.99
563654-6365433.37733.38
664950-6495034.05734.06
10min1118083-11808361.91865.948.9362.1066.158.96
2143905-14390575.45875.73
3131396-13139668.89969.14
4128512-12851267.38667.60
5112833-11283359.16559.35
6119785-11978562.81063.00
15min1150017-15001778.66380.264.9679.1980.855.01
2165022-16502286.53187.23
3158977-15897783.36183.99
4150383-15038378.85579.44
5143819-14381975.41375.93
6150202-15020278.76079.30
20min1164948-16494886.49287.473.0287.4588.493.06
2171595-17159589.97791.15
3173018-17301890.72391.82
4161590-16159084.73185.75
5161220-16122084.53785.47
6168472-16847288.34089.32
30min1174878-17487891.69991.842.3093.1493.362.29
2177252-17725292.94494.62
3177287-17728792.96294.56
4167217-16721787.68289.18
5176432-17643292.51493.92
6177828-17782893.24694.71
45min1179247-17924793.99094.871.3195.9496.901.32
2181810-18181095.33497.53
3182282-18228295.58197.69
4177910-17791093.28995.27
5179912-17991294.33896.26
6184416-18441696.70098.68
60min1180441-18044194.61694.901.7397.0997.451.71
2181926-18192695.39498.12
3179755-17975594.25696.90
4178654-17865493.67996.18
5178330-17833093.50995.95
6186772-18677297.935100.46
极限1182058-18205895.46495.511.8198.4698.581.76
2181505-18150595.17498.43
3180639-18063994.72097.89
4179565-17956594.15697.18
5180450-18045094.62097.58
6188621-18862198.905101.97
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%
110.954200514196784185004189904180624190560.20
211.054197524191914194720.10
单位质量响应值RSD%判断
38269.9537961.270.58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%
5min1180403-18040342.38549.8116.9042.3949.8216.89
2269427-26942763.30163.30
3238355-23835556.00156.00
4213139-21313950.07650.08
5183638-18363843.14543.15
6187177-18717743.97743.98
10min1309753-30975372.77677.038.3873.0177.308.41
2371445-37144587.27087.62
3342284-34228480.41980.73
4334022-33402278.47778.76
5293958-29395869.06569.30
6315600-31560074.14974.39
15min1375449-37544988.21189.604.8088.8590.304.84
2408535-40853595.98496.82
3397315-39731593.34894.11
4373391-37339187.72788.44
5358078-35807884.12984.75
6375385-37538588.19688.85
20min1399222-39922293.79694.782.8994.9395.992.94
2413169-41316997.07398.44
3418321-41832198.28399.56
4392645-39264592.25193.45
5389060-38906091.40892.50
6408131-40813195.88997.04
30min1411821-41182196.75696.462.2198.4198.192.19
2413869-41386997.23799.15
3415419-41541997.60199.42
4392996-39299692.33394.05
5410649-41064996.48198.08
6418679-41867998.367100.05
45min1409282-40928296.16097.161.5298.3599.421.54
2416768-41676897.918100.37
3416455-41645597.845100.21
4406939-40693995.60997.84
5408638-40863896.00898.14
6423071-42307199.399101.62
60min1406534-40653495.51496.062.0998.2498.872.08
2413900-41390097.245100.24
3404784-40478495.10398.01
4405469-40546995.26498.02
5399165-39916593.78396.45
6423357-42335799.466102.24
极限1398295-39829593.57895.662.3396.8399.002.30
2409950-40995096.31799.85
3404471-40447195.02998.47
4403640-40364094.83498.12
5401784-40178494.39897.59
6424883-42488399.825103.16
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