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%
110.676674366875668626650166240666440.41
210.756638566529664570.16
单位质量响应值RSD%判断
6245.926182.050.73数据可信
供试品溶液-X0801批-pH1.0盐酸溶液-无水乙醇(95:5)
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
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.03244.950.000.03244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
51238-12380.1840.18
6-0.0000.00
75min1-0.0000.18118.010.000.18116.58
22486-24860.3700.37
33334-33340.4960.50
4-0.0000.00
5629-6290.0930.10
6643-6430.0960.10
90min11186-11860.1760.07116.460.180.07115.76
2-0.0000.00
3813-8130.1210.13
4-0.0000.00
5-0.0000.00
6648-6480.0960.10
120min12891-28910.4300.4379.050.430.4377.71
2709-7090.1050.11
31812-18120.2690.28
46940-69401.0321.03
53813-38130.5670.57
61181-11810.1760.18
极限12142-21420.3180.5846.630.320.5846.70
26533-65330.9710.98
34987-49870.7410.75
42173-21730.3230.33
54765-47650.7080.72
62699-26990.4010.40
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%
110.676697666984660366604866617665320.71
210.756630165991661460.34
单位质量响应值RSD%判断
6235.436153.120.94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%
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min11245-12450.1860.1083.700.190.1084.15
21065-10650.1590.16
3-0.0000.00
4-0.0000.00
51073-10730.1600.16
6609-6090.0910.09
75min11205-12050.1800.1291.870.180.1292.43
2741-7410.1110.11
3860-8600.1280.13
4-0.0000.00
51847-18470.2750.28
6-0.0000.00
90min1587-5870.0880.27136.130.090.27135.76
21054-10540.1570.16
3686-6860.1020.10
46820-68201.0171.02
51208-12080.1800.18
6520-5200.0780.08
120min11555-15550.2320.3971.340.240.4069.04
21353-13530.2020.21
33588-35880.5350.54
41330-13300.1980.21
51819-18190.2710.28
65978-59780.8910.89
极限14780-47800.7130.9141.230.720.9140.75
24073-40730.6070.61
37222-72221.0771.08
47309-73091.0901.10
59895-98951.4761.48
63196-31960.4770.49
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%
110.676963569521697326971269849696900.18
210.756964769984698160.35
单位质量响应值RSD%判断
6531.406494.510.41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
30min1-0.0000.04244.950.000.04244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
51793-17930.2540.25
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1882-8820.1250.22218.310.130.22217.49
2-0.0000.00
3-0.0000.00
4-0.0000.00
58427-84271.1951.20
6-0.0000.00
75min1998-9980.1420.14199.720.140.14200.94
2-0.0000.00
3-0.0000.00
4-0.0000.00
54963-49630.7040.72
6-0.0000.00
90min11748-17480.2480.1592.300.250.1594.10
2656-6560.0930.09
3-0.0000.00
4-0.0000.00
52280-22800.3230.34
61574-15740.2230.22
120min12431-24310.3450.3572.920.350.3571.89
25307-53070.7530.75
3-0.0000.00
41310-13100.1860.19
53142-31420.4460.47
62504-25040.3550.36
极限16193-61930.8780.7056.310.890.7156.97
22909-29090.4130.42
31717-17170.2440.24
42905-29050.4120.41
58190-81901.1621.19
67782-77821.1041.11
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%
110.676975269671697116984069629697210.12
210.756939769788695920.40
单位质量响应值RSD%判断
6534.306473.670.66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
30min11085-10850.1540.03244.950.150.02244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min12329-23290.3310.1399.620.330.1398.44
21307-13070.1860.19
3752-7520.1070.11
4-0.0000.00
5891-8910.1270.13
6-0.0000.00
75min1-0.0000.04156.760.000.04156.89
2880-8800.1250.13
3681-6810.0970.10
4-0.0000.00
5-0.0000.00
6-0.0000.00
90min1-0.0000.1293.630.000.1293.49
22015-20150.2860.29
3-0.0000.00
41215-12150.1730.17
51289-12890.1830.18
6600-6000.0850.09
120min1677-6770.0960.29113.340.100.29113.48
26495-64950.9220.93
31849-18490.2630.26
41143-11430.1620.16
52068-20680.2940.30
6-0.0000.00
极限11745-17450.2480.6042.160.250.6042.46
26803-68030.9660.98
33807-38070.5410.55
44719-47190.6700.67
55175-51750.7350.74
62964-29640.4210.42
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%
110.677093570477706897107770838708030.33
210.757076970652707100.12
单位质量响应值RSD%判断
6635.716577.670.63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
30min1-0.0000.30244.950.000.30244.95
213037-130371.8231.82
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00244.95
2-0.0000.02
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1716-7160.1000.26176.030.100.26173.06
2717-7170.1000.12
3-0.0000.00
41273-12730.1780.18
5-0.0000.00
68515-85151.1901.19
75min1-0.0000.05160.370.000.06141.03
2-0.0000.02
3-0.0000.00
41418-14180.1980.20
5910-9100.1270.13
6-0.0000.01
90min11060-10600.1480.68178.550.150.69178.11
222666-226663.1693.19
31669-16690.2330.23
41491-14910.2080.21
51349-13490.1890.19
61057-10570.1480.16
120min11542-15420.2160.2942.860.220.3044.13
23011-30110.4210.47
31255-12550.1750.18
43340-33400.4670.47
52154-21540.3010.30
61294-12940.1810.19
极限13640-36400.5090.7238.580.510.7338.33
25613-56130.7850.84
33656-36560.5110.52
48485-84851.1861.20
55913-59130.8270.83
63401-34010.4750.49
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%
110.677081071037709437093471102709650.16
210.757068371002708420.32
单位质量响应值RSD%判断
6650.896589.950.66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
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.07114.980.000.07115.76
2-0.0000.00
31144-11440.1600.16
4-0.0000.00
51145-11450.1600.16
6677-6770.0940.09
75min1-0.0000.39107.740.000.39107.38
2-0.0000.00
36508-65080.9080.91
46023-60230.8400.84
5691-6910.0960.10
63429-34290.4780.48
90min1819-8190.1140.1085.250.110.1180.58
2862-8620.1200.12
31540-15400.2150.23
4-0.0000.01
51123-11230.1570.16
6-0.0000.01
120min11022-10220.1430.3643.840.140.3643.80
24267-42670.5950.60
33046-30460.4250.44
41848-18480.2580.27
52206-22060.3080.31
63019-30190.4210.43
极限12735-27350.3820.7537.850.380.7538.14
23750-37500.5230.53
37588-75881.0591.08
44676-46760.6520.66
55641-56410.7870.79
67704-77041.0751.08
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