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%
110.676655867191666706650066743667320.41
210.756651966558665380.05
单位质量响应值RSD%判断
6254.176189.580.74数据可信
供试品溶液-2024041521批-pH1.0盐酸溶液-无水乙醇(80:20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1-0.0000.06244.950.000.06244.95
2-0.0000.00
3-0.0000.00
42422-24220.3600.36
5-0.0000.00
6-0.0000.00
30min12157-21570.3200.3318.490.320.3318.54
21833-18330.2720.27
32146-21460.3190.32
42961-29610.4400.44
51882-18820.2790.28
62217-22170.3290.33
45min14305-43050.6390.3745.730.640.3844.86
22384-23840.3540.36
33410-34100.5060.51
41219-12190.1810.19
51693-16930.2510.25
62053-20530.3050.31
60min15006-50060.7430.7025.120.750.7124.43
25430-54300.8060.81
35277-52770.7830.79
42334-23340.3470.36
54856-48560.7210.73
65361-53610.7960.80
75min15702-57020.8470.7117.900.860.7217.73
24545-45450.6750.69
35029-50290.7470.76
43236-32360.4800.49
55295-52950.7860.80
64747-47470.7050.72
90min16340-63400.9410.9818.800.971.0018.54
25619-56190.8340.86
37347-73471.0911.11
44760-47600.7070.72
57735-77351.1481.17
67798-77981.1581.18
120min19533-95331.4151.1921.301.451.2221.10
27255-72551.0771.11
39396-93961.3951.43
44974-49740.7380.76
58351-83511.2401.27
68703-87031.2921.32
极限115249-152492.2641.8519.922.311.9019.73
211895-118951.7661.81
310906-109061.6191.67
48637-86371.2821.31
514446-144462.1452.19
613813-138132.0512.10
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%
110.677075570980707707076570185706910.43
210.756979370697702450.91
单位质量响应值RSD%判断
6625.216534.420.98数据可信
供试品溶液-2024041721批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1-0.0000.03244.950.000.03244.95
2-0.0000.00
31445-14450.2030.20
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min11585-15850.2230.1851.990.220.1852.30
21669-16690.2340.23
31683-16830.2360.24
41095-10950.1540.15
5-0.0000.00
61661-16610.2330.23
45min13152-31520.4420.3747.290.440.3846.92
22143-21430.3010.30
34630-46300.6500.65
41536-15360.2160.22
51265-12650.1780.18
63258-32580.4570.46
60min14673-46730.6560.6425.200.660.6525.20
23869-38690.5430.55
36770-67700.9500.96
44246-42460.5960.60
53529-35290.4950.50
64289-42890.6020.61
75min15350-53500.7510.5624.280.760.5823.95
24500-45000.6320.64
34469-44690.6270.65
42830-28300.3970.41
52951-29510.4140.42
64047-40470.5680.58
90min17555-75551.0610.7923.561.080.8123.52
25420-54200.7610.78
35953-59530.8360.86
44212-42120.5910.60
54173-41730.5860.60
66546-65460.9190.94
120min16989-69890.9810.7822.061.010.8021.95
26379-63790.8960.92
36030-60300.8470.88
43692-36920.5180.54
54538-45380.6370.65
65669-56690.7960.82
极限116254-162542.2821.6032.312.321.6432.03
212770-127701.7931.83
312666-126661.7781.82
45584-55840.7840.81
58898-88981.2491.27
612348-123481.7331.77
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%
110.676598265797657956560965972658310.24
210.756590764877653921.12
单位质量响应值RSD%判断
6169.736082.981.01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%
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min12474-24740.3730.2432.660.370.2432.27
21184-11840.1790.18
31001-10010.1510.15
41522-15220.2290.23
51524-15240.2300.23
61657-16570.2500.25
45min12603-26030.3920.3531.430.400.3531.20
21547-15470.2330.24
33415-34150.5150.52
42044-20440.3080.31
51588-15880.2390.24
62715-27150.4090.41
60min14705-47050.7090.6218.950.720.6319.06
24463-44630.6730.68
32893-28930.4360.44
44156-41560.6270.63
53522-35220.5310.54
64965-49650.7490.76
75min15042-50420.7600.6814.670.770.6914.61
24590-45900.6920.70
33633-36330.5480.56
45278-52780.7960.81
53802-38020.5730.58
64697-46970.7080.72
90min17146-71461.0770.9724.591.100.9924.44
27074-70741.0671.08
37373-73731.1121.13
47085-70851.0681.09
53234-32340.4880.50
66848-68481.0331.05
120min18665-86651.3061.226.291.341.256.20
28792-87921.3261.35
37490-74901.1291.16
47975-79751.2021.23
57833-78331.1811.20
67903-79031.1921.22
极限114984-149842.2591.9613.902.312.0013.83
214441-144412.1772.22
313714-137142.0682.11
410777-107771.6251.67
510810-108101.6301.66
613298-132982.0052.05
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%
110.676527066230656726621566331659440.70
210.756609665659658780.47
单位质量响应值RSD%判断
6180.326128.190.60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%
15min1-0.0000.02244.950.000.02244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6844-8440.1270.13
30min1-0.0000.1952.400.000.1952.52
21378-13780.2070.21
31303-13030.1960.20
41402-14020.2100.21
51610-16100.2420.24
61958-19580.2940.30
45min1629-6290.0940.3051.170.090.3151.59
2905-9050.1360.14
32570-25700.3860.39
42699-26990.4050.41
52172-21720.3260.33
63220-32200.4830.49
60min11361-13610.2040.5855.760.210.5855.61
21070-10700.1610.16
35227-52270.7850.79
44622-46220.6940.70
54495-44950.6750.68
66359-63590.9540.96
75min12030-20300.3050.5841.570.310.5941.52
21747-17470.2620.27
34326-43260.6490.66
45003-50030.7510.76
54278-42780.6420.65
65657-56570.8490.87
90min13283-32830.4930.7533.690.500.7734.10
22580-25800.3870.39
35263-52630.7900.81
46267-62670.9410.96
56077-60770.9120.93
66625-66250.9941.02
120min14228-42280.6351.0422.650.651.0622.85
26100-61000.9160.93
37431-74311.1151.14
48475-84751.2721.30
56950-69501.0431.07
68193-81931.2301.27
极限16407-64070.9621.3261.130.981.3659.93
27026-70261.0551.08
313635-136352.0462.09
4-0.0000.04
511985-119851.7991.84
613846-138462.0782.13
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%
110.676595366093651506602866328659100.68
210.756770967578676440.14
单位质量响应值RSD%判断
6177.136292.471.31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%
15min1-0.0000.02244.950.000.02244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5763-7630.1130.11
6-0.0000.00
30min11163-11630.1720.2898.050.170.2897.93
21070-10700.1590.16
3664-6640.0980.10
41158-11580.1720.17
55682-56820.8420.84
61752-17520.2600.26
45min12387-23870.3540.3736.960.360.3837.50
21868-18680.2770.28
31096-10960.1620.16
43540-35400.5240.53
53361-33610.4980.51
62836-28360.4200.42
60min14335-43350.6420.6632.490.650.6632.47
26788-67881.0061.01
32578-25780.3820.38
43464-34640.5130.52
55051-50510.7480.76
64339-43390.6430.65
75min15752-57520.8520.6525.720.860.6625.32
24166-41660.6170.63
32364-23640.3500.36
44582-45820.6790.69
54923-49230.7290.75
64503-45030.6670.68
90min16076-60760.9000.8216.880.920.8417.36
25586-55860.8280.85
33797-37970.5630.57
45795-57950.8590.88
56527-65270.9671.00
65435-54350.8050.83
120min18129-81291.2041.3358.981.231.3657.91
219490-194902.8882.92
34835-48350.7160.73
46463-64630.9580.99
57466-74661.1061.15
67380-73801.0931.12
极限113381-133811.9831.8121.152.021.8521.25
214452-144522.1412.20
37278-72781.0781.10
411742-117421.7401.78
513598-135982.0152.06
612989-129891.9241.96
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%
110.676516265664653106524665908654580.49
210.756534964591649700.83
单位质量响应值RSD%判断
6134.776043.721.06数据可信
供试品溶液-2024041721批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min11259-12590.1910.2350.120.190.2350.11
21559-15590.2360.24
31109-11090.1680.17
42868-28680.4350.44
5639-6390.0970.10
61581-15810.2400.24
45min12654-26540.4030.3033.390.400.3033.25
22256-22560.3420.34
31269-12690.1930.19
41873-18730.2840.29
51168-11680.1770.18
62674-26740.4060.41
60min14835-48350.7330.5127.780.740.5227.79
24249-42490.6450.65
32686-26860.4070.41
42681-26810.4070.41
52826-28260.4290.43
62906-29060.4410.45
75min14456-44560.6760.5135.140.690.5234.59
23496-34960.5300.54
32820-28200.4280.44
43025-30250.4590.47
51524-15240.2310.24
64743-47430.7190.73
90min18064-80641.2230.7140.111.240.7339.75
25201-52010.7890.81
33629-36290.5510.56
44118-41180.6250.64
52516-25160.3820.39
64689-46890.7110.73
120min17801-78011.1830.7432.431.220.7632.50
24977-49770.7550.78
34058-40580.6160.63
44332-43320.6570.68
53133-31330.4750.49
65072-50720.7690.79
极限115435-154352.3411.3638.822.391.3938.84
29159-91591.3891.42
36403-64030.9710.99
48685-86851.3171.35
55512-55120.8360.85
68618-86181.3071.34
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