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100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3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%
110.751351023135016813510601351490135170413510890.05
210.671340835133998913404120.05
单位质量响应值RSD%判断
125682.70125624.370.04数据可信
供试品溶液-X0794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%
60min158148-581484.2744.499.734.274.499.73
259802-598024.3964.40
356599-565994.1614.16
460066-600664.4154.42
558927-589274.3324.33
672923-729235.3615.36
120min1114090-1140908.3879.0811.048.399.0811.05
2130510-1305109.5949.60
3112561-1125618.2748.28
4120611-1206118.8668.87
5115272-1152728.4748.48
6147919-14791910.87310.88
240min1203060-20306014.92716.4710.7714.9516.4910.77
2224805-22480516.52516.55
3219012-21901216.09916.12
4215424-21542415.83615.86
5210874-21087415.50115.52
6270911-27091119.91419.94
360min1303624-30362422.31923.125.4722.3623.175.48
2326239-32623923.98224.03
3309371-30937122.74222.78
4300539-30053922.09222.14
5303460-30346022.30722.35
6344112-34411225.29525.35
480min1387837-38783728.51028.784.8528.5828.864.85
2388295-38829528.54328.62
3380685-38068527.98428.06
4382949-38294928.15028.23
5379995-37999527.93328.01
6429602-42960231.58031.67
600min1497256-49725636.55333.804.7036.6733.924.69
2462895-46289534.02734.15
3444788-44478832.69632.81
4449134-44913433.01533.13
5437080-43708032.12932.25
6467951-46795134.39934.54
720min1633953-63395346.60139.0410.4046.7739.2110.36
2540426-54042639.72639.90
3515493-51549337.89338.06
4499910-49991036.74836.92
5473785-47378534.82834.99
6522577-52257738.41438.61
840min1720183-72018352.94043.5510.9753.1843.7810.92
2585953-58595343.07343.31
3560420-56042041.19641.42
4550858-55085840.49340.72
5548114-54811440.29140.51
6589175-58917543.31043.56
960min1795449-79544958.47347.4911.4058.7947.7911.35
2612666-61266645.03745.34
3612268-61226845.00745.29
4607065-60706544.62544.91
5619304-61930445.52545.80
6629553-62955346.27846.59
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1868307-86830763.82952.6610.7564.2453.0310.72
2707856-70785652.03452.40
3665080-66508048.88949.24
4663036-66303648.73949.09
5685977-68597750.42650.77
6707866-70786652.03552.42
1200min1907302-90730266.69556.1710.2467.2056.6210.21
2761364-76136455.96756.41
3679626-67962649.95950.39
4710018-71001852.19352.62
5761015-76101555.94256.36
6765526-76552656.27356.73
1320min11025569-102556975.38961.2012.2175.9961.7312.16
2840862-84086261.81162.34
3781557-78155757.45257.95
4745883-74588354.82955.33
5767952-76795256.45256.96
6833623-83362361.27961.82
1440min11064420-106442078.24564.7410.6278.9665.3610.59
2876800-87680064.45365.07
3809898-80989859.53560.12
4819711-81971160.25660.84
5852025-85202562.63263.22
6861254-86125463.31063.95
1560min11103127-110312781.09068.3910.0281.9369.1110.00
2946805-94680569.59970.32
3843990-84399062.04162.72
4857517-85751763.03563.71
5910692-91069266.94467.63
6919761-91976167.61168.34
1680min11096265-109626580.58670.017.9081.5470.837.90
2971460-97146071.41172.23
3899822-89982266.14566.92
4900208-90020866.17466.94
5924788-92478867.98068.77
6921927-92192767.77068.60
1800min11089974-108997480.12372.616.2081.2073.546.22
21007037-100703774.02674.96
3918947-91894767.55168.42
4935533-93553368.77069.64
5973057-97305771.52972.42
61001719-100171973.63674.57
1920min11112901-111290181.80875.285.6783.0176.325.70
21036131-103613176.16577.21
3949446-94944669.79370.76
4973324-97332471.54872.52
51023730-102373075.25476.25
61049099-104909977.11878.16
2040min11109819-110981981.58276.104.5482.9077.254.59
21029502-102950275.67876.83
3981245-98124572.13173.21
4994219-99421973.08474.16
51032412-103241275.89277.00
61064179-106417978.22779.39
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2160min11096541-109654180.60676.492.9582.0577.763.01
21016591-101659174.72976.00
31015843-101584374.67475.86
41023123-102312375.20976.40
51042308-104230876.61977.84
61049282-104928277.13278.41
极限11080275-108027579.41076.322.7780.9777.702.83
21040769-104076976.50677.89
31006940-100694074.01975.32
41008932-100893274.16675.47
51032639-103263975.90877.24
61059932-105993277.91579.31
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100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3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%
110.751482520148225914823361482380148244414823880.01
210.671459351145891314591320.03
单位质量响应值RSD%判断
137896.56136750.890.59数据可信
供试品溶液-X0794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%
60min155164-551643.7113.878.443.713.868.47
253665-536653.6103.61
355057-550573.7033.70
457276-572763.8533.85
556715-567153.8153.81
667042-670424.5094.51
120min1113616-1136167.6428.1012.267.658.1112.27
2125781-1257818.4608.47
3112589-1125897.5737.58
4116603-1166037.8437.85
5106337-1063377.1537.16
6147623-1476239.9309.94
240min1196720-19672013.23214.489.0613.2514.509.06
2224550-22455015.10415.12
3209961-20996114.12314.14
4206026-20602613.85813.88
5204039-20403913.72413.74
6250319-25031916.83716.86
360min1289587-28958719.47920.405.0419.5220.445.05
2312805-31280521.04021.08
3302406-30240620.34120.38
4287750-28775019.35519.39
5298793-29879320.09820.13
6328342-32834222.08522.13
480min1375285-37528525.24325.414.9025.3125.484.91
2378587-37858725.46525.54
3351394-35139423.63623.70
4373728-37372825.13825.21
5378516-37851625.46025.53
6409290-40929027.53027.61
600min1476091-47609132.02330.053.9932.1330.163.98
2447635-44763530.10930.22
3423646-42364628.49628.60
4445609-44560929.97330.08
5434566-43456629.23029.34
6452867-45286730.46130.58
720min1602819-60281940.54834.838.1540.7034.998.11
2510800-51080034.35834.51
3506314-50631434.05634.20
4493441-49344133.19033.34
5493672-49367233.20633.36
6500269-50026933.65033.82
840min1670501-67050145.10038.369.1645.3138.569.13
2570217-57021738.35538.56
3535371-53537136.01136.21
4543163-54316336.53536.73
5529916-52991635.64435.84
6572653-57265338.51938.74
960min1773115-77311552.00242.8310.6452.2843.0910.59
2628321-62832142.26342.53
3610297-61029741.05141.30
4594596-59459639.99540.25
5605087-60508740.70040.95
6609041-60904140.96641.24
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1838253-83825356.38447.039.9656.7447.369.92
2689855-68985546.40246.73
3661355-66135544.48544.80
4654463-65446344.02144.34
5664843-66484344.72045.03
6686252-68625246.16046.50
1200min1888594-88859459.77050.819.2160.2151.219.18
2752654-75265450.62651.02
3692266-69226646.56446.94
4708181-70818147.63548.02
5745591-74559150.15150.53
6745134-74513450.12050.53
1320min1966363-96636365.00154.879.7965.5355.359.76
2827995-82799555.69456.17
3775615-77561552.17052.62
4747778-74777850.29850.75
5763245-76324551.33851.79
6813740-81374054.73555.22
1440min11006778-100677867.71958.538.1868.3559.098.17
2868636-86863658.42758.98
3815966-81596654.88555.41
4811193-81119354.56455.09
5862464-86246458.01258.55
6856295-85629557.59758.16
1560min11039034-103903469.88960.968.0670.6261.608.05
2914792-91479261.53262.18
3841427-84142756.59757.21
4838410-83841056.39457.00
5895157-89515760.21160.83
6908919-90891961.13761.79
1680min11024606-102460668.91862.825.5569.7663.565.57
2959928-95992864.56865.31
3884356-88435659.48560.18
4904169-90416960.81761.51
5899569-89956960.50861.22
6931130-93113062.63163.37
1800min11038498-103849869.85364.954.4870.7965.784.51
2980878-98087865.97766.81
3911672-91167261.32262.11
4936092-93609262.96563.75
5961774-96177464.69265.49
6965125-96512564.91865.75
1920min11069778-106977871.95768.034.1573.0068.964.17
21019495-101949568.57569.51
3949166-94916663.84464.72
4980675-98067565.96366.84
51016930-101693068.40269.30
61032695-103269569.46270.40
2040min11074543-107454372.27768.913.5473.4369.943.57
21014853-101485368.26269.30
3988093-98809366.46267.43
4992145-99214566.73567.71
51014450-101445068.23569.24
61063005-106300571.50172.54
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2160min11103833-110383374.24769.903.1675.5171.033.20
21021727-102172768.72569.86
31021628-102162868.71869.79
41017007-101700768.40769.49
51040479-104047969.98671.09
61030490-103049069.31470.46
极限11089944-108994473.31370.162.4574.6971.402.50
21034289-103428969.57070.81
31025291-102529168.96470.14
41020010-102001068.60969.79
51037018-103701869.75370.96
61052131-105213170.77072.02
点击查看处理图标(人工保存)
 
原始图谱下载图谱(王丹 于 2026-05-15 12:46:19 完成)
生成报告数据部分(等待生成报告)
Current page cost:73 ms