氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011427315142559414238291425594142683914258340.10
210.721415864141479514153300.06
单位质量响应值RSD%判断
129503.54132027.051.37数据可信
耐用性--供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min191170-911706.1826.403.336.186.403.34
293532-935326.3426.34
398617-986176.6876.69
492445-924456.2696.27
592489-924896.2726.27
697991-979916.6456.64
120min1341925-34192523.18624.413.7023.2024.423.69
2362585-36258524.58724.60
3348508-34850823.63323.64
4367529-36752924.92224.93
5379034-37903425.70325.71
6360430-36043024.44124.45
240min1801160-80116054.32755.395.0754.3755.445.06
2754126-75412651.13851.18
3822034-82203455.74355.79
4882131-88213159.81859.86
5815630-81563055.30855.36
6825893-82589356.00456.05
360min11245008-124500884.42584.381.9284.5584.501.93
21204973-120497381.71081.83
31249037-124903784.69884.83
41279554-127955486.76786.90
51247981-124798184.62684.76
61239204-123920484.03184.16
480min11515390-1515390102.760102.750.56103.01103.010.55
21528254-1528254103.632103.88
31508051-1508051102.262102.52
41504686-1504686102.034102.30
51515123-1515123102.742103.00
61520022-1520022103.074103.33
极限11505492-1505492102.088102.660.50102.49103.070.50
21524975-1524975103.410103.81
31510306-1510306102.415102.82
41507509-1507509102.225102.64
51518841-1518841102.994103.41
61516515-1516515102.836103.25
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011423040142172914207031417643142039614207020.15
210.721411185141209514116400.05
单位质量响应值RSD%判断
129037.42131682.841.44数据可信
耐用性--供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min196962-969626.5966.127.286.606.127.29
296837-968376.5876.59
380231-802315.4575.46
492100-921006.2656.26
587601-876015.9595.96
686340-863405.8735.87
120min1341557-34155723.23322.497.4123.2422.507.41
2367688-36768825.01125.02
3298255-29825520.28820.30
4339356-33935623.08423.09
5325136-32513622.11622.13
6311899-31189921.21621.22
240min1750158-75015851.02751.267.1951.0751.307.19
2823622-82362256.02556.07
3775786-77578652.77152.81
4718728-71872848.88948.93
5783884-78388453.32153.36
6669181-66918145.51945.56
360min11182951-118295180.46781.536.1380.5981.656.13
21279071-127907187.00587.14
31253742-125374285.28285.40
41175924-117592479.98980.11
51227330-122733083.48683.61
61072656-107265672.96473.07
480min11511348-1511348102.805103.301.43103.05103.551.43
21507459-1507459102.541102.80
31561709-1561709106.231106.48
41517873-1517873103.249103.49
51502860-1502860102.228102.48
61510804-1510804102.768102.99
极限11512074-1512074102.855103.281.42103.25103.671.41
21507235-1507235102.525102.94
31561654-1561654106.227106.63
41509202-1509202102.659103.05
51506259-1506259102.459102.86
61513243-1513243102.934103.31
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011399716140578214047341406302140479814042660.19
210.721388716138834713885320.02
单位质量响应值RSD%判断
127544.60129527.241.10数据可信
耐用性--供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min191209-912096.2926.372.466.296.372.47
295202-952026.5676.57
389610-896106.1826.18
491619-916196.3206.32
595117-951176.5626.56
691545-915456.3156.32
120min1340721-34072123.50424.034.4323.5124.044.43
2365809-36580925.23525.25
3362453-36245325.00425.01
4328764-32876422.68022.69
5357101-35710124.63424.64
6335465-33546523.14223.15
240min1795283-79528354.86253.796.9354.9153.846.93
2829516-82951657.22457.27
3800161-80016155.19955.25
4675474-67547446.59746.64
5774892-77489253.45653.50
6803062-80306255.39955.44
360min11235264-123526485.21483.146.6485.3483.276.63
21256722-125672286.69486.83
31208678-120867883.38083.51
41047866-104786672.28772.40
51218922-121892284.08784.21
61263741-126374187.17987.31
480min11485578-1485578102.482103.510.91102.74103.760.91
21506719-1506719103.940104.20
31506305-1506305103.912104.17
41481280-1481280102.185102.41
51509780-1509780104.151104.40
61513379-1513379104.400104.66
极限11494027-1494027103.065103.640.74103.47104.050.75
21511171-1511171104.247104.67
31497180-1497180103.282103.69
41495631-1495631103.175103.55
51495382-1495382103.158103.57
61521042-1521042104.928105.34
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011417021141856214162811417631141579914170590.08
210.721405885140892014074020.16
单位质量响应值RSD%判断
128706.54131287.501.41数据可信
耐用性--供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min188323-883236.0256.176.626.026.176.62
299651-996516.7976.80
393861-938616.4026.40
486821-868215.9225.92
591519-915196.2436.24
682471-824715.6255.63
120min1385064-38506426.26625.2210.2326.2725.2210.22
2406089-40608927.70027.71
3352101-35210124.01724.03
4387247-38724726.41526.42
5386346-38634626.35326.36
6301258-30125820.54920.56
240min1890258-89025860.72655.1310.1960.7755.1710.18
2869651-86965159.32059.37
3749371-74937151.11651.16
4843018-84301857.50457.55
5824381-82438156.23356.28
6672444-67244445.86945.91
360min11283593-128359387.55685.115.3087.7085.245.30
21280481-128048187.34487.48
31167626-116762679.64679.77
41300220-130022088.69088.83
51296089-129608988.40988.54
61158743-115874379.04079.15
480min11499208-1499208102.264102.431.10102.53102.681.11
21524748-1524748104.006104.28
31477164-1477164100.760101.00
41507262-1507262102.813103.08
51509719-1509719102.981103.25
61491463-1491463101.735101.96
极限11500792-1500792102.372102.831.15102.80103.241.15
21525317-1525317104.045104.47
31478497-1478497100.851101.24
41506288-1506288102.747103.17
51509671-1509671102.977103.40
61524282-1524282103.974104.35
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