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%
110.676536565389653126556565509654280.17
210.756544865389654180.07
单位质量响应值RSD%判断
6131.966085.400.54数据可信
供试品溶液-X0734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%
15min1-0.0000.07144.770.000.07142.68
2386-3860.0580.06
3333-3330.0500.05
4-0.0000.00
5302-3020.0460.05
61847-18470.2790.28
30min1572-5720.0860.1945.280.090.2045.03
21034-10340.1560.16
3786-7860.1190.12
41368-13680.2070.21
51824-18240.2760.28
62001-20010.3030.31
45min11980-19800.2990.3727.060.300.3727.31
22990-29900.4520.45
31379-13790.2090.21
42748-27480.4160.42
52452-24520.3710.37
63118-31180.4710.48
60min13175-31750.4800.6336.290.480.6336.43
23559-35590.5380.54
32996-29960.4530.46
43359-33590.5080.51
56893-68931.0421.05
64876-48760.7370.75
75min13961-39610.5990.6616.860.610.6717.10
24338-43380.6560.67
33396-33960.5140.52
44026-40260.6090.62
54930-49300.7450.76
65440-54400.8230.84
90min14456-44560.6740.8621.280.690.8821.23
26940-69401.0491.07
34328-43280.6540.67
45092-50920.7700.79
56293-62930.9520.98
66972-69721.0541.08
120min15316-53160.8041.1019.090.831.1318.71
26806-68061.0291.06
38967-89671.3561.38
46327-63270.9570.98
57864-78641.1891.22
68519-85191.2881.32
极限19228-92281.3951.9521.331.421.9821.30
211808-118081.7851.82
311013-110131.6651.70
413238-132382.0022.04
515530-155302.3482.39
616421-164212.4832.53
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%
110.676551065508653176554265465654680.14
210.756538465521654520.15
单位质量响应值RSD%判断
6135.716088.560.55数据可信
供试品溶液-X0794批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1-0.0000.04110.000.000.04109.96
2469-4690.0710.07
3506-5060.0760.08
4-0.0000.00
5547-5470.0830.08
6-0.0000.00
30min11040-10400.1570.2055.110.160.2054.41
21058-10580.1600.16
31196-11960.1810.18
42793-27930.4220.42
5917-9170.1390.14
6918-9180.1390.14
45min11291-12910.1950.2949.520.200.2949.14
23824-38240.5780.58
31735-17350.2620.26
41653-16530.2500.25
51650-16500.2490.25
61363-13630.2060.21
60min12812-28120.4250.4516.840.430.4616.55
22483-24830.3750.38
32744-27440.4150.42
43015-30150.4560.46
52927-29270.4420.45
63944-39440.5960.60
75min12367-23670.3580.3514.180.370.3613.73
22685-26850.4060.42
32713-27130.4100.42
42211-22110.3340.35
51847-18470.2790.29
62175-21750.3290.34
90min14399-43990.6650.666.670.680.676.54
24093-40930.6190.63
34445-44450.6720.69
44258-42580.6430.66
54832-48320.7300.74
64032-40320.6090.62
120min14645-46450.7020.697.020.720.707.05
24513-45130.6820.70
35011-50110.7570.78
44360-43600.6590.68
54629-46290.7000.72
64055-40550.6130.63
极限19295-92951.4051.325.791.431.355.68
28459-84591.2781.31
39408-94081.4221.45
48528-85281.2891.32
58640-86401.3061.33
68121-81211.2271.25
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%
110.676626266452659496661665894662350.48
210.756755368149678510.63
单位质量响应值RSD%判断
6207.596311.721.18数据可信
供试品溶液-X0734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
30min11764-17640.2600.2130.950.260.2130.62
21116-11160.1650.16
3794-7940.1170.12
41502-15020.2220.22
51469-14690.2170.22
62054-20540.3030.30
45min12697-26970.3980.3424.510.400.3423.75
21383-13830.2040.21
31929-19290.2850.29
42818-28180.4160.42
52143-21430.3160.32
62650-26500.3910.39
60min14791-47910.7070.5819.510.710.5919.27
23309-33090.4880.49
32991-29910.4410.45
44029-40290.5950.60
53750-37500.5530.56
64896-48960.7220.73
75min14985-49850.7360.6018.710.750.6218.54
23726-37260.5500.56
33224-32240.4760.48
45032-50320.7430.75
53492-34920.5150.53
64129-41290.6090.62
90min17072-70721.0440.8417.381.060.8617.40
24857-48570.7170.73
34406-44060.6500.66
45935-59350.8760.90
55493-54930.8110.83
66428-64280.9490.97
120min19147-91471.3501.0518.551.381.0818.43
26168-61680.9100.93
36048-60480.8920.91
47946-79461.1731.20
55842-58420.8620.89
67603-76031.1221.15
极限117358-173582.5621.8626.722.611.9026.52
29944-99441.4671.50
39473-94731.3981.43
414401-144012.1252.17
59670-96701.4271.46
614979-149792.2102.25
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%
110.676669166240661176631766431663590.33
210.756615066378662640.25
单位质量响应值RSD%判断
6219.216164.090.63数据可信
供试品溶液-X0794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
30min1-0.0000.1857.320.000.1856.94
21701-17010.2540.25
31285-12850.1920.19
41601-16010.2390.24
5844-8440.1260.13
61871-18710.2790.28
45min11773-17730.2650.3838.830.260.3838.72
22393-23930.3570.36
32371-23710.3540.36
41983-19830.2960.30
52211-22110.3300.33
64492-44920.6700.67
60min13117-31170.4650.8262.990.470.8362.62
26719-67191.0021.01
33627-36270.5410.55
43127-31270.4660.47
512012-120121.7921.80
64389-43890.6550.66
75min14143-41430.6180.6320.390.630.6519.80
24375-43750.6530.67
34253-42530.6340.65
44410-44100.6580.67
52759-27590.4120.43
65456-54560.8140.83
90min14916-49160.7330.8318.440.750.8518.17
26052-60520.9030.93
35370-53700.8010.82
45149-51490.7680.78
54576-45760.6830.71
67420-74201.1071.13
120min15637-56370.8410.8419.650.860.8618.96
25430-54300.8100.84
36149-61490.9170.94
45835-58350.8700.89
53673-36730.5480.58
67016-70161.0471.08
极限110762-107621.6061.8817.041.631.9217.07
213007-130071.9401.98
311941-119411.7811.82
411448-114481.7081.74
511640-116401.7361.78
616690-166902.4902.54
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%
110.676405963758634936363664208638310.47
210.756443864353643960.10
单位质量响应值RSD%判断
5982.295990.330.10数据可信
供试品溶液-X0801批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min11045-10450.1610.1584.500.160.1584.58
22029-20290.3130.31
31522-15220.2350.23
41255-12550.1940.19
5-0.0000.00
6-0.0000.00
30min13317-33170.5120.4939.740.510.4840.38
22786-27860.4300.43
34843-48430.7470.75
44254-42540.6560.66
51581-15810.2440.24
62096-20960.3230.32
45min12280-22800.3520.3338.060.360.3438.04
2757-7570.1170.12
32438-24380.3760.39
43265-32650.5040.51
51887-18870.2910.29
62373-23730.3660.37
60min16553-65531.0110.9034.141.020.9033.98
24190-41900.6470.66
38748-87481.3501.36
47149-71491.1031.12
53972-39720.6130.62
64187-41870.6460.65
75min16079-60790.9380.6622.370.960.6822.27
23968-39680.6120.63
34124-41240.6360.66
43936-39360.6070.63
53255-32550.5020.51
64198-41980.6480.66
90min18244-82441.2721.0716.481.301.1016.56
25503-55030.8490.87
37674-76741.1841.22
47706-77061.1891.22
55648-56480.8710.89
66971-69711.0761.10
120min17147-71471.1031.0622.821.151.0922.78
26185-61850.9540.98
37677-76771.1851.23
48561-85611.3211.36
54072-40720.6280.65
67388-73881.1401.17
极限114926-149262.3031.9422.872.361.9922.90
29089-90891.4021.44
314201-142012.1912.25
416170-161702.4952.55
510121-101211.5621.59
611080-110801.7101.75
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%
110.676399663340632306382863229635250.57
210.756395363346636500.68
单位质量响应值RSD%判断
5953.615920.930.39数据可信
供试品溶液-X0801批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1-0.0000.08112.810.000.08112.41
21183-11830.1840.18
3765-7650.1190.12
4-0.0000.00
5-0.0000.00
61025-10250.1590.16
30min12509-25090.3900.3342.760.390.3343.03
23214-32140.5000.50
32641-26410.4110.41
4788-7880.1230.12
51286-12860.2000.20
62280-22800.3550.36
45min12890-28900.4500.3953.320.450.3953.37
23862-38620.6010.61
33097-30970.4820.49
4-0.0000.00
52279-22790.3550.36
62719-27190.4230.43
60min15890-58900.9160.7934.700.920.8035.12
26903-69031.0741.09
35854-58540.9110.92
41810-18100.2820.28
54620-46200.7190.72
65514-55140.8580.87
75min11254-12540.1950.5854.390.210.5953.79
26427-64271.0001.02
35225-52250.8130.83
41715-17150.2670.27
53253-32530.5060.52
64382-43820.6820.70
90min16900-69001.0730.9829.691.091.0029.70
28204-82041.2761.31
36794-67941.0571.08
42696-26960.4190.43
56697-66971.0421.06
66423-64230.9991.02
120min17434-74341.1570.9735.811.191.0035.78
28783-87831.3661.41
36715-67151.0451.08
42175-21750.3380.35
55755-57550.8950.92
66678-66781.0391.07
极限112506-125061.9461.5150.681.991.5550.43
214946-149462.3252.39
311896-118961.8511.90
4830-8300.1290.14
58396-83961.3061.34
69586-95861.4911.54
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