依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.484932284908474910444911664934294919430.26
211.384950684941554946120.14
单位质量响应值RSD%判断
42852.1843463.271.01数据可信
供试品溶液-2024040821批-瑞舒伐他汀钙-pH7.0磷酸盐溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1469256-46925692.91487.617.7692.9187.617.75
2428710-42871084.88684.89
3395928-39592878.39578.40
4415290-41529082.22982.23
5483602-48360295.75595.75
6462017-46201791.48191.48
10min1504989-50498999.99097.852.17100.5198.342.19
2476216-47621694.29394.76
3494624-49462497.93798.37
4489656-48965696.95497.41
5504859-50485999.964100.50
6494861-49486197.98498.49
15min1504826-50482699.95799.021.38101.03100.051.40
2488904-48890496.80597.80
3500389-50038999.079100.06
4496071-49607198.22499.22
5508468-508468100.679101.77
6501831-50183199.364100.42
20min1503841-50384199.76299.121.25101.39100.701.28
2491241-49124197.26898.80
3500351-50035199.071100.60
4495510-49551098.11399.65
5508019-508019100.590102.24
6504674-50467499.927101.53
30min1505152-505152100.02299.051.22102.20101.181.25
2491876-49187697.39399.47
3500065-50006599.015101.10
4494283-49428397.87099.96
5507262-507262100.440102.65
6502684-50268499.533101.69
45min1500314-50031499.06498.870.93101.80101.550.96
2493706-49370697.756100.37
3498828-49882898.770101.40
4494457-49445797.904100.53
5504341-50434199.861102.62
6504422-50442299.877102.59
60min1501725-50172599.34398.700.97102.63101.931.00
2492956-49295697.607100.76
3497030-49703098.414101.59
4493257-49325797.667100.84
5501308-50130899.261102.58
6504634-50463499.919103.19
极限1499686-49968698.94098.531.04102.78102.311.07
2492045-49204597.427101.13
3496763-49676398.361102.09
4491405-49140597.300101.02
5503956-50395699.785103.65
6501847-50184799.368103.19
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.074407474406324406004404764409694406850.05
211.194411244407384409310.07
单位质量响应值RSD%判断
39808.9439404.020.73数据可信
供试品溶液-2024040821批-依折麦布-pH7.0磷酸盐溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1186996-18699642.49341.0431.2942.4941.0431.29
2227395-22739551.67451.67
3121504-12150427.61127.61
4120340-12034027.34627.35
5260683-26068359.23859.24
6166646-16664637.86937.87
10min1403322-40332291.65187.568.1791.8987.798.23
2419897-41989795.41895.71
3340244-34024477.31877.47
4370825-37082584.26784.42
5413028-41302893.85794.19
6364696-36469682.87483.08
15min1420022-42002295.44695.302.5196.1996.022.59
2430203-43020397.76098.58
3402384-40238491.43892.02
4421031-42103195.67696.30
5429562-42956297.61498.46
6413175-41317593.89094.56
20min1421433-42143395.76796.421.4097.0497.671.48
2429555-42955597.61398.97
3414864-41486494.27495.37
4426229-42622996.85798.01
5430932-43093297.92699.32
6422939-42293996.10997.30
30min1422968-42296896.11696.720.9297.9298.501.01
2428192-42819297.30399.21
3420395-42039595.53197.15
4426804-42680496.98898.68
5431254-43125497.99999.94
6424202-42420296.39698.12
45min1419483-41948395.32496.740.9697.6799.061.01
2429288-42928897.552100.00
3421984-42198495.89298.04
4427295-42729597.09999.33
5429428-42942897.584100.07
6426682-42668296.96099.22
60min1420746-42074695.61196.570.7098.4899.420.76
2427522-42752297.151100.14
3421743-42174395.83798.52
4425774-42577496.75499.52
5427170-42717097.071100.09
6426776-42677696.98199.78
极限1421506-42150695.78496.700.8499.19100.100.92
2427184-42718497.074100.60
3422563-42256396.02499.23
4425381-42538196.66499.97
5431514-43151498.058101.62
6425197-42519796.62299.96
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.484916564907714906914905644906524908670.10
211.384914504919174916840.07
单位质量响应值RSD%判断
42758.4543205.980.74数据可信
供试品溶液-2024040821批-瑞舒伐他汀钙
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1413217-41321782.15191.927.7582.1591.927.75
2470786-47078693.59693.60
3486196-48619696.65996.66
4488581-48858197.13497.13
5493894-49389498.19098.19
6421373-42137383.77283.77
10min1488413-48841397.10099.161.9197.5699.681.93
2500513-50051399.506100.03
3502836-50283699.968100.50
4505725-505725100.542101.08
5509298-509298101.252101.80
6485988-48598896.61897.08
15min1501978-50197899.797100.040.91100.79101.100.94
2502625-50262599.926101.00
3503497-503497100.099101.19
4506018-506018100.600101.70
5509430-509430101.279102.39
6495736-49573698.55699.56
20min1499246-49924699.25499.790.87100.80101.400.90
2500759-50075999.555101.18
3501940-50194099.789101.44
4504780-504780100.354102.01
5508633-508633101.120102.79
6496222-49622298.653100.20
30min1499474-49947499.29999.610.85101.40101.780.88
2500581-50058199.519101.70
3501248-50124899.652101.85
4502551-50255199.911102.13
5507694-507694100.933103.17
6494712-49471298.353100.45
45min1497560-49756098.91999.280.92101.57102.000.95
2498183-49818399.043101.78
3500114-50011499.426102.18
4500952-50095299.593102.36
5506669-506669100.730103.52
6492729-49272997.958100.60
60min1498341-49834199.07499.070.83102.28102.350.85
2496577-49657798.723102.01
3496838-49683898.775102.08
4500100-50010099.424102.75
5505215-505215100.441103.79
6492961-49296198.004101.19
极限1497198-49719898.84798.721.04102.60102.551.05
2496264-49626498.661102.49
3494579-49457998.326102.18
4496981-49698198.804102.68
5505127-505127100.423104.33
6489250-48925097.267101.00
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.074392264390564391724386704386624389570.07
211.194383574391124387340.13
单位质量响应值RSD%判断
39652.8539207.690.80数据可信
供试品溶液-2024040821批-依折麦布
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1187617-18761742.82557.4128.6342.8357.4028.63
2278732-27873263.62363.62
3274977-27497762.76662.77
4297314-29731467.86467.86
5329794-32979475.27875.28
6140520-14052032.07532.07
10min1397775-39777590.79593.444.8991.0393.764.97
2424083-42408396.80097.15
3410960-41096093.80594.15
4417710-41771095.34695.72
5430165-43016598.18998.61
6375548-37554885.72285.90
15min1426784-42678497.41797.761.0098.1698.601.10
2428873-42887397.89498.79
3427646-42764697.61498.48
4433286-43328698.90199.81
5431871-43187198.57899.54
6421178-42117896.13796.79
20min1426083-42608397.25797.890.6298.5499.270.71
2427770-42777097.64299.08
3429796-42979698.10599.52
4432523-43252398.727100.18
5430831-43083198.34199.85
6426177-42617797.27898.47
30min1426485-42648597.34997.830.3599.1799.760.44
2428097-42809797.71799.69
3429394-42939498.01399.97
4430807-43080798.335100.34
5429030-42903097.93099.99
6427811-42781197.65199.38
45min1424563-42456396.91097.510.4399.2799.970.51
2425835-42583597.20099.72
3428398-42839897.785100.29
4429215-42921597.972100.52
5428436-42843697.794100.40
6426577-42657797.37099.64
60min1425188-42518897.05397.330.3399.96100.340.37
2424877-42487796.982100.04
3425905-42590597.216100.26
4428583-42858397.828100.92
5427081-42708197.485100.63
6426887-42688797.441100.25
极限1424093-42409396.80397.100.29100.25100.650.38
2424810-42481096.966100.57
3425125-42512597.038100.62
4426898-42689897.443101.08
5426916-42691697.447101.13
6424602-42460296.919100.27
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