氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
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2500
标示量(mg)80供试品稀释倍数2系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.677253172387728427251772270725090.30
210.757218672081721340.11
单位质量响应值RSD%判断
6795.606710.140.90数据可信
供试品溶液-2024041521批-pH1.0盐酸溶液-无水乙醇(60:40)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min111669-116691.5961.5310.201.601.5310.09
210224-102241.3991.40
312015-120151.6431.64
412809-128091.7521.75
59909-99091.3551.36
610541-105411.4421.44
30min122378-223783.0612.988.503.083.008.53
221951-219513.0033.02
322594-225943.0913.11
424422-244223.3413.36
519204-192042.6272.64
620204-202042.7642.78
45min123706-237063.2433.219.803.293.259.76
223775-237753.2523.30
324232-242323.3153.36
426922-269223.6833.73
522074-220743.0193.06
620038-200382.7412.78
60min130132-301324.1224.037.484.204.107.52
229599-295994.0494.13
329763-297634.0714.15
432965-329654.5094.60
526925-269253.6833.75
627238-272383.7263.80
75min127616-276163.7783.947.933.904.057.92
229725-297254.0664.18
329646-296464.0554.18
432446-324464.4384.57
526349-263493.6043.71
626861-268613.6743.78
90min132599-325994.4594.467.514.624.627.55
233354-333544.5624.72
333288-332884.5534.72
436516-365164.9955.17
529673-296734.0594.20
630347-303474.1514.29
120min131201-312014.2684.477.854.474.677.78
234037-340374.6564.86
333223-332234.5444.75
436901-369015.0485.27
530466-304664.1674.35
630276-302764.1414.33
极限136362-363624.9745.159.015.225.408.95
238641-386415.2865.54
338377-383775.2495.50
443534-435345.9556.23
534318-343184.6944.92
634714-347144.7484.97
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
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2500
标示量(mg)80供试品稀释倍数2系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.677275472211720677228772799724240.46
210.757209772412722540.31
单位质量响应值RSD%判断
6787.636721.300.70数据可信
供试品溶液-2024041521批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min19613-96131.3151.429.851.311.429.82
210486-104861.4341.43
311224-112241.5351.53
48913-89131.2191.22
510346-103461.4151.41
611708-117081.6011.60
30min118533-185332.5342.758.132.552.778.10
220803-208032.8452.86
321926-219262.9983.01
419248-192482.6322.64
518392-183922.5152.53
621956-219563.0033.02
45min121087-210872.8843.077.662.923.117.70
221985-219853.0073.05
324664-246643.3733.42
421502-215022.9402.98
520920-209202.8612.90
624587-245873.3623.41
60min126506-265063.6253.836.913.693.906.94
227560-275603.7693.84
330730-307304.2024.28
427481-274813.7583.83
525778-257783.5253.59
629893-298934.0884.17
75min126563-265633.6333.765.143.743.875.20
227772-277723.7983.91
329220-292203.9964.12
426508-265083.6253.73
525790-257903.5273.63
628959-289593.9604.08
90min129218-292183.9964.197.164.144.347.12
230679-306794.1954.34
333223-332234.5434.70
429744-297444.0684.21
527791-277913.8003.94
633173-331734.5364.70
120min129361-293614.0154.407.174.204.597.08
233113-331134.5284.72
334718-347184.7484.95
432088-320884.3884.57
529464-294644.0294.21
634152-341524.6704.88
极限131291-312914.2794.9810.724.505.2110.52
238439-384395.2575.49
339971-399715.4665.72
436782-367825.0305.26
531927-319274.3664.58
639987-399875.4685.72
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
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2500
标示量(mg)80供试品稀释倍数2系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.677228272149715527175272200719870.45
210.757248371913721980.56
单位质量响应值RSD%判断
6746.676716.090.33数据可信
供试品溶液-2024041821批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min17631-76311.0471.2311.641.051.2311.56
27767-77671.0661.07
310248-102481.4061.41
49407-94071.2911.29
59206-92061.2631.26
69546-95461.3101.31
30min116654-166542.2852.4610.992.302.4710.91
214557-145571.9972.01
319901-199012.7312.74
418911-189112.5952.61
518577-185772.5492.56
618976-189762.6042.62
45min118246-182462.5042.6812.532.542.7212.48
215139-151392.0772.11
321110-211102.8972.94
421004-210042.8822.92
520258-202582.7802.82
621473-214732.9472.99
60min122765-227653.1243.4512.233.183.5112.27
219991-199912.7432.79
327649-276493.7943.86
427386-273863.7583.83
526251-262513.6023.67
626693-266933.6633.73
75min117191-171912.3593.4018.412.453.4918.15
221023-210232.8852.96
328244-282443.8763.98
427365-273653.7553.86
527100-271003.7193.82
627618-276183.7903.89
90min126650-266503.6574.0011.033.774.1411.11
224216-242163.3233.43
332492-324924.4594.61
431752-317524.3574.50
529047-290473.9864.12
630945-309454.2464.39
120min126760-267603.6724.2610.843.824.4410.94
227420-274203.7633.90
335021-350214.8065.00
433382-333824.5814.77
530861-308614.2354.41
633012-330124.5304.72
极限129342-293424.0264.9112.084.215.1312.08
231937-319374.3824.56
340434-404345.5485.79
439275-392755.3895.62
536418-364184.9975.22
637502-375025.1465.38
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
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2500
标示量(mg)80供试品稀释倍数2系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.677247972590724147230172371724310.16
210.757161672161718880.54
单位质量响应值RSD%判断
6788.286687.261.07数据可信
供试品溶液-2024041821批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min18353-83531.1451.2714.481.151.2814.46
210644-106441.4591.46
311238-112381.5411.54
48569-85691.1751.17
57877-78771.0801.08
69108-91081.2491.25
30min117009-170092.3322.4612.042.342.4712.04
219756-197562.7082.72
321243-212432.9122.93
415571-155712.1352.15
516328-163282.2392.25
617716-177162.4292.44
45min118677-186772.5612.7912.502.602.8212.45
222228-222283.0473.09
324640-246403.3783.42
418688-186882.5622.60
518527-185272.5402.57
619146-191462.6252.66
60min123064-230643.1623.4510.663.223.5210.77
227157-271573.7233.80
329596-295964.0574.14
424377-243773.3423.40
522622-226223.1013.16
624217-242173.3203.38
75min123914-239143.2793.5310.803.373.6310.86
227863-278633.8203.93
330319-303194.1574.28
424636-246363.3773.47
523101-231013.1673.26
624491-244913.3583.45
90min126537-265373.6383.8910.543.764.0310.58
230339-303394.1594.31
333398-333984.5794.74
427375-273753.7533.88
525151-251513.4483.57
627470-274703.7663.90
120min126984-269843.6994.0911.313.864.2611.32
233200-332004.5524.74
334817-348174.7734.98
428908-289083.9634.13
526691-266913.6593.81
628480-284803.9044.07
极限129217-292174.0064.5712.824.204.7812.75
238003-380035.2105.44
339333-393335.3925.65
431770-317704.3564.56
530082-300824.1244.32
631480-314804.3164.52
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