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2
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.031495891149811014965251497698149724814970940.06
210.941473100147120214721510.10
单位质量响应值RSD%判断
135729.28134565.900.61数据可信
影响因素30天-供试品溶液-X0734批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1174432-17443224.11024.075.5924.1124.075.59
2183324-18332425.33925.34
3184672-18467225.52625.53
4175385-17538524.24224.24
5168742-16874223.32423.32
6158443-15844321.90021.90
480min1300672-30067241.55942.145.3541.6042.185.35
2323385-32338544.69944.74
3319593-31959344.17544.21
4309826-30982642.82542.86
5296592-29659240.99541.03
6279242-27924238.59738.63
720min1411027-41102756.81357.225.4856.9157.325.48
2435937-43593760.25660.36
3436846-43684660.38260.49
4420936-42093658.18358.28
5402295-40229555.60655.70
6376979-37697952.10752.20
1440min1669261-66926192.50693.362.5492.6993.542.55
2686169-68616994.84495.04
3697842-69784296.45796.65
4685373-68537394.73494.92
5653027-65302790.26390.44
6660930-66093091.35591.52
极限1731759-731759101.145102.551.49101.47102.881.50
2751700-751700103.901104.24
3748990-748990103.527103.87
4751604-751604103.888104.22
5741873-741873102.543102.86
6725554-725554100.287100.59
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2
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.031502358150315315015031500875150156915018920.06
210.941467421147000214687120.13
单位质量响应值RSD%判断
136164.28134251.551.01数据可信
高温50天-供试品溶液-X0734批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1174780-17478024.14824.276.3224.1524.276.32
2153969-15396921.27321.27
3180756-18075624.97424.97
4183707-18370725.38225.38
5178350-17835024.64224.64
6182426-18242625.20525.20
480min1309563-30956342.77141.985.6942.8142.025.69
2268738-26873837.13037.16
3311918-31191843.09643.13
4309302-30930242.73542.77
5310169-31016942.85442.89
6313402-31340243.30143.34
720min1424801-42480158.69256.774.5858.7956.874.58
2373319-37331951.57951.67
3415229-41522957.37057.47
4418466-41846657.81757.92
5413867-41386757.18257.28
6419698-41969857.98758.09
1440min1665100-66510091.89391.901.1192.0892.081.11
2665311-66531191.92292.09
3667862-66786292.27592.46
4665444-66544491.94192.13
5652197-65219790.11090.30
6674815-67481593.23593.43
极限1746372-746372103.122100.481.81103.45100.811.81
2711925-71192598.36398.67
3720737-72073799.58099.91
4726136-726136100.326100.65
5719146-71914699.36099.68
6739396-739396102.158102.49
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2
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.031496098149441414911251493625149477314940070.13
210.941473971146518314695770.43
单位质量响应值RSD%判断
135449.41134330.620.59数据可信
影响因素30天-供试品溶液-X0734批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1138507-13850719.18118.422.2419.1818.422.24
2132541-13254118.35518.36
3130334-13033418.04918.05
4132015-13201518.28218.28
5130878-13087818.12518.12
6133996-13399618.55718.56
480min1244442-24444233.85232.312.4133.8832.342.41
2230493-23049331.92031.95
3229390-22939031.76731.79
4233388-23338832.32132.35
5230574-23057431.93131.96
6231615-23161532.07532.10
720min1332722-33272246.07743.243.3946.1643.323.39
2304088-30408842.11242.19
3307592-30759242.59742.67
4313716-31371643.44543.52
5305708-30570842.33642.41
6309787-30978742.90142.98
1440min1518845-51884571.85367.323.5672.0067.463.55
2480627-48062766.56066.70
3471294-47129465.26765.41
4483412-48341266.94667.09
5473720-47372065.60365.74
6488732-48873267.68267.82
极限1573161-57316179.37573.594.1779.6373.844.16
2519464-51946471.93872.18
3513338-51333871.09071.33
4534040-53404073.95774.20
5516292-51629271.49971.74
6532188-53218873.70073.94
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2
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.031486843148681914851001488194148790414869720.09
210.941459384145938014593820.01
单位质量响应值RSD%判断
134811.60133398.720.75数据可信
高温50天-供试品溶液-X0734批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1137762-13776219.19018.843.7819.1918.843.78
2128078-12807817.84117.84
3135615-13561518.89118.89
4143234-14323419.95219.95
5132501-13250118.45718.46
6134104-13410418.68018.68
480min1233700-23370032.55432.252.6832.5832.282.69
2221296-22129630.82630.85
3231777-23177732.28632.31
4240037-24003733.43733.47
5228974-22897431.89631.92
6233384-23338432.51032.54
720min1310725-31072543.28343.183.0043.3643.253.00
2297457-29745741.43541.51
3308552-30855242.98143.06
4325016-32501645.27445.35
5304307-30430742.38942.46
6313733-31373343.70243.78
1440min1495248-49524868.98767.772.6169.1367.912.61
2476412-47641266.36366.50
3475217-47521766.19766.34
4502607-50260770.01270.16
5474055-47405566.03566.17
6495468-49546869.01769.16
极限1537578-53757874.88373.582.8975.1373.822.89
2516726-51672671.97972.21
3514857-51485771.71871.96
4546283-54628376.09676.35
5512205-51220571.34971.59
6541519-54151975.43275.68
点击查看处理图标(自动生成)
　
原始图谱下载图谱(谢鑫慧 于 2024-02-23 13:22:06 完成)
生成报告数据部分(等待生成报告)
Current page cost:74 ms