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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4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%
111.011468790146817914684301467925146903514684720.04
210.721438756143933314390440.03
单位质量响应值RSD%判断
133376.20134239.180.46数据可信
供试品溶液-2024041521批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1386653-38665325.62126.278.2025.6226.278.19
2431029-43102928.56128.56
3380489-38048925.21225.21
4429473-42947328.45828.46
5345850-34585022.91722.92
6405099-40509926.84326.84
480min1728853-72885348.29649.926.7648.3349.966.75
2777743-77774351.53651.58
3732610-73261048.54548.58
4838617-83861755.57055.61
5689841-68984145.71145.75
6752666-75266649.87449.91
720min11100028-110002872.89277.065.6773.0077.175.67
21176932-117693277.98878.11
31138283-113828375.42775.54
41272386-127238684.31384.44
51098411-109841172.78472.89
61191270-119127078.93879.05
960min11490935-149093598.794100.092.0399.01100.322.04
21510109-1510109100.065100.30
31468897-146889797.33497.56
41550685-1550685102.754103.01
51502184-150218499.54099.75
61540454-1540454102.076102.31
1200min11508662-150866299.969100.590.94100.34100.970.95
21501117-150111799.46999.86
31520614-1520614100.761101.13
41537732-1537732101.895102.30
51509267-1509267100.009100.37
61531006-1531006101.450101.84
1440min11497280-149728099.21599.600.8799.73100.130.88
21488266-148826698.61899.15
31506753-150675399.843100.36
41524579-1524579101.024101.58
51493529-149352998.96699.48
61508460-150846099.956100.49
极限11498990-149899099.32899.501.01100.00100.191.02
21490450-149045098.76299.45
31509949-1509949100.054100.73
41528075-1528075101.255101.97
51487326-148732698.55599.22
61495151-149515199.07499.76
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4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%
111.011464886146502814652561465055146483214650110.02
210.721443063144306714430650.01
单位质量响应值RSD%判断
133061.85134614.270.83数据可信
供试品溶液-2024041521批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1432704-43270428.66725.6514.7828.6725.6614.78
2422033-42203327.96027.96
3315791-31579120.92120.92
4415487-41548727.52627.53
5311665-31166520.64820.65
6425712-42571228.20328.20
480min1782231-78223151.82348.4112.6951.8748.4412.69
2806207-80620753.41153.45
3608638-60863840.32240.35
4812108-81210853.80253.84
5619229-61922941.02441.05
6755781-75578150.07050.11
720min11210185-121018580.17575.6212.0580.3075.7312.06
21279029-127902984.73684.86
3926427-92642761.37661.47
41246275-124627582.56682.69
51025953-102595367.96968.06
61160492-116049276.88277.00
960min11547034-1547034102.49196.639.04102.7396.869.04
21567057-1567057103.817104.07
31232937-123293781.68281.87
41530901-1530901101.422101.67
51365760-136576090.48190.68
61507774-150777499.890100.12
1200min11536997-1536997101.826101.170.99102.22101.541.01
21553270-1553270102.904103.31
31514549-1514549100.339100.65
41518878-1518878100.626101.02
51517636-1517636100.543100.87
61521205-1521205100.780101.16
1440min11520798-1520798100.753100.451.27101.30100.981.29
21552878-1552878102.878103.44
31504567-150456799.677100.13
41503252-150325299.590100.14
51503769-150376999.625100.11
61512394-1512394100.196100.73
极限11523203-1523203100.912100.561.19101.61101.241.21
21552263-1552263102.837103.55
31507327-150732799.860100.47
41505726-150572699.754100.45
51506696-150669699.818100.45
61512450-1512450100.200100.88
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4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%
111.011467435146692914667101466967146608614668250.04
210.721442290144174814420190.03
单位质量响应值RSD%判断
133226.61134516.700.69数据可信
供试品溶液-2024041721批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1427734-42773428.33028.885.1428.3328.895.14
2427548-42754828.31828.32
3424342-42434228.10528.11
4434307-43430728.76528.77
5421695-42169527.93027.93
6480987-48098731.85731.86
480min1873388-87338857.84756.693.5057.8956.733.50
2835235-83523555.32055.36
3851659-85165956.40856.45
4815540-81554054.01554.06
5857983-85798356.82656.87
6901709-90170959.72359.77
720min11255497-125549783.15582.032.3383.2882.152.33
21226839-122683981.25781.38
31220005-122000580.80480.93
41200623-120062379.52079.64
51246118-124611882.53482.66
61281739-128173984.89385.03
960min11524965-1524965101.002101.321.42101.26101.571.42
21549652-1549652102.637102.88
31521709-1521709100.787101.03
41523722-1523722100.920101.16
51499008-149900899.28399.53
61559545-1559545103.293103.56
1200min11527278-1527278101.156100.700.93101.56101.100.94
21536462-1536462101.764102.17
31509062-150906299.949100.35
41506314-150631499.767100.16
51508239-150823999.895100.29
61535143-1535143101.677102.10
1440min11516922-1516922100.470100.050.90101.03100.610.90
21524840-1524840100.994101.55
31504355-150435599.637100.19
41497091-149709199.15699.70
51495230-149523099.03399.58
61525159-1525159101.015101.59
极限11514261-1514261100.29399.861.20101.00100.561.20
21521464-1521464100.771101.48
31492811-149281198.87399.57
41489422-148942298.64899.34
51494850-149485099.00899.71
61533456-1533456101.565102.29
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4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%
111.011469390146827314683851467555146794614683100.05
210.721438500143774414381220.04
单位质量响应值RSD%判断
133361.49134153.170.42数据可信
供试品溶液-2024041721批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1448749-44874929.74728.014.8929.7528.014.90
2407233-40723326.99526.99
3391125-39112525.92725.93
4423933-42393328.10228.10
5436576-43657628.94028.94
6427609-42760928.34528.35
480min1842833-84283355.87053.422.5855.9153.462.58
2789859-78985952.35852.40
3807369-80736953.51953.56
4795314-79531452.72052.76
5786767-78676752.15352.20
6813324-81332453.91453.96
720min11232648-123264881.71077.693.7281.8477.823.71
21156717-115671776.67776.80
31216917-121691780.66780.79
41164201-116420177.17377.29
51123815-112381574.49674.62
61138057-113805775.44075.56
960min11545050-1545050102.41999.922.59102.67100.162.58
21531746-1531746101.537101.77
31529551-1529551101.391101.63
41500114-150011499.44099.68
51501306-150130699.51999.75
61436789-143678995.24295.48
1200min11534259-1534259101.703100.721.03102.11101.101.04
21526126-1526126101.164101.55
31521909-1521909100.885101.28
41530236-1530236101.437101.82
51511981-1511981100.227100.61
61491582-149158298.87499.25
1440min11523963-1523963101.02199.941.00101.58100.481.01
21509249-1509249100.045100.58
31511786-1511786100.214100.76
41518800-1518800100.679101.22
51500949-150094999.495100.03
61481589-148158998.21298.74
极限11517724-1517724100.60799.640.91101.32100.330.92
21508421-150842199.991100.68
31505376-150537699.789100.48
41511677-1511677100.206100.90
51496494-149649499.20099.88
61479430-147943098.06998.74
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