依折麦布辛伐他汀片项目信息
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DSMF-387-240606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(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.101891621894321892721895931894201893760.09
211.061889951889921889940.01
单位质量响应值RSD%判断
17060.9017088.070.12数据可信
供试品溶液-X024017批-依折麦布-pH4.5(内含0.25%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187232-8723245.86546.922.2545.8746.922.24
291235-9123547.97047.97
389259-8925946.93146.93
10min199874-9987452.51252.477.7352.5952.557.73
2107468-10746856.50556.59
392041-9204148.39448.47
15min1135813-13581371.40872.521.3471.5772.681.34
2139185-13918573.18173.36
3138770-13877072.96373.12
20min1144068-14406875.74977.291.7976.0377.581.79
2149134-14913478.41278.71
3147814-14781477.71878.00
30min1159118-15911883.66283.630.2784.0784.040.26
2158603-15860383.39183.82
3159437-15943783.83084.24
45min1164530-16453086.50786.871.1287.0687.421.10
2163820-16382086.13486.70
3167294-16729487.96188.51
60min1170847-17084789.82988.960.8990.5289.660.88
2167913-16791388.28689.00
3168796-16879688.75089.45
极限1173945-17394591.45891.290.8192.3092.140.79
2172113-17211390.49491.35
3174848-17484891.93292.78
依折麦布辛伐他汀片项目信息
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500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.994177184185984183374183004180674182040.08
210.994165444168604167020.06
单位质量响应值RSD%判断
38053.1437916.470.26数据可信
供试品溶液-X024017批-辛伐他汀-pH4.5(内含0.25%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135645-356458.4038.450.778.408.450.81
236165-361658.5268.53
335754-357548.4298.43
10min139635-396359.3449.565.909.369.585.93
243271-4327110.20110.22
338762-387629.1389.15
15min152058-5205812.27312.642.6012.3012.672.59
254132-5413212.76212.79
354700-5470012.89612.92
20min154164-5416412.76913.193.2412.8213.243.22
255890-5589013.17613.23
357786-5778613.62313.67
30min162819-6281914.81014.831.1314.8814.901.12
263663-6366315.00915.08
362250-6225014.67614.75
45min163587-6358714.99115.151.2015.0915.251.17
264078-6407815.10715.21
365090-6509015.34515.44
60min168755-6875516.20916.401.2416.3316.531.25
270474-7047416.61416.74
369503-6950316.38616.51
极限169956-6995616.49216.711.3916.6416.861.38
270741-7074116.67716.83
371902-7190216.95117.10
依折麦布辛伐他汀片项目信息
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DSMF-387-240606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(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.101897251899201898651900251896481898370.08
211.061919651918631919140.04
单位质量响应值RSD%判断
17102.4317352.081.03数据可信
供试品溶液-2024030121批-依折麦布-pH7.0(内含0.25%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166142-6614234.47038.0414.6334.4738.0414.64
285290-8529044.44944.45
367529-6752935.19335.19
10min163680-6368033.18735.406.5933.2435.466.58
267502-6750235.17935.25
372590-7259037.83037.89
15min1111402-11140258.05764.599.6758.1764.729.67
2135277-13527770.50070.63
3125159-12515965.22765.35
20min1120134-12013462.60864.587.0362.8264.827.01
2117755-11775561.36861.62
3133887-13388769.77570.01
30min1143459-14345974.76480.096.0575.0880.426.05
2161638-16163884.23884.59
3155919-15591981.25781.60
45min1154203-15420380.36380.814.0180.8081.283.99
2149319-14931977.81778.31
3161654-16165484.24684.73
60min1163377-16337785.14487.892.7285.7288.492.73
2171719-17171989.49190.11
3170824-17082489.02589.65
极限1171719-17171989.49189.560.5690.2190.310.56
2170958-17095889.09589.87
3172857-17285790.08490.86
依折麦布辛伐他汀片项目信息
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500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.994189044185924189654188154181404186830.09
210.994232714233444233080.02
单位质量响应值RSD%判断
38096.7238517.560.78数据可信
供试品溶液-2024030121批-辛伐他汀-pH7.0(内含0.25%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1192025-19202544.89149.4613.3344.8949.4613.32
2243883-24388357.01457.01
3198809-19880946.47746.48
10min1182602-18260242.68845.476.8442.7645.556.83
2192086-19208644.90545.00
3208841-20884148.82248.90
15min1291714-29171468.19675.779.3968.3475.939.39
2352031-35203182.29682.47
3328618-32861876.82376.98
20min1303565-30356570.96673.086.7671.2373.376.73
2297502-29750269.54969.86
3336745-33674578.72379.01
30min1360082-36008284.17889.705.5884.5690.115.58
2401831-40183193.93894.36
3389190-38919090.98391.40
45min1373733-37373387.37087.843.4687.8988.393.43
2363872-36387285.06485.64
3389568-38956891.07191.64
60min1397272-39727292.87295.312.2293.5496.012.24
2412452-41245296.42197.14
3413360-41336096.63397.35
极限1404515-40451594.56694.830.5295.3895.690.54
2408085-40808595.40096.28
3404371-40437194.53295.41
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