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)1.5补液体积(ml)1.5
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%
111.314729144732914731504733344731834731740.04
211.344724424721864723140.04
单位质量响应值RSD%判断
41836.7841650.260.32数据可信
中间条件3月-供试品溶液-2024030921批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1389545-38954579.74179.166.8479.7479.166.84
2368696-36869675.47375.47
3421803-42180386.34486.34
4347738-34773871.18371.18
5385591-38559178.93178.93
6407007-40700783.31583.32
10min1473638-47363896.955100.522.4497.09100.652.45
2497142-497142101.766101.89
3502492-502492102.861103.01
4478450-47845097.94098.06
5499483-499483102.245102.38
6495065-495065101.341101.48
15min1486715-48671599.632102.111.3399.93102.411.33
2500579-500579102.470102.77
3505639-505639103.506103.82
4496528-496528101.641101.92
5501071-501071102.570102.87
6502385-502385102.839103.15
20min1486880-48688099.666102.151.32100.13102.621.33
2500595-500595102.473102.94
3505784-505784103.535104.02
4497310-497310101.801102.25
5500552-500552102.464102.94
6503012-503012102.968103.45
30min1485570-48557099.397101.991.40100.02102.631.41
2499516-499516102.252102.89
3505046-505046103.384104.04
4496163-496163101.566102.19
5499722-499722102.294102.94
6503467-503467103.061103.71
45min1485558-48555899.395101.861.32100.19102.671.33
2498617-498617102.068102.88
3504019-504019103.174104.01
4495902-495902101.512102.30
5499074-499074102.162102.98
6502335-502335102.829103.65
60min1484868-48486899.254101.701.32100.21102.681.33
2497918-497918101.925102.90
3503371-503371103.041104.05
4494930-494930101.313102.27
5498467-498467102.037103.02
6501457-501457102.649103.64
极限1483511-48351198.976101.481.37100.10102.621.37
2496511-496511101.637102.78
3503307-503307103.028104.20
4493880-493880101.098102.23
5497591-497591101.858103.01
6499552-499552102.260103.42
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)1.5补液体积(ml)1.5
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%
110.694088064090664088594090264089264089370.03
210.734080694080584080640.01
单位质量响应值RSD%判断
38254.1638030.200.42数据可信
中间条件3月-供试品溶液-2024030921批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1204761-20476148.31643.0113.2348.3243.0113.23
2167832-16783239.60239.60
3220225-22022551.96551.96
4161909-16190938.20438.20
5171085-17108540.36940.37
6167820-16782039.59939.60
10min1388545-38854591.68290.824.0691.7690.894.06
2396090-39609093.46293.53
3401629-40162994.76994.86
4357519-35751984.36184.42
5387160-38716091.35591.42
6378395-37839589.28789.35
15min1425617-425617100.42999.810.99100.66100.031.00
2422093-42209399.59899.82
3427580-427580100.892101.14
4418036-41803698.64098.84
5418271-41827198.69698.92
6426262-426262100.581100.80
20min1431576-431576101.835101.200.79102.24101.600.80
2427721-427721100.926101.31
3431667-431667101.857102.27
4425320-425320100.359100.73
5424858-424858100.250100.63
6432287-432287102.003102.39
30min1431399-431399101.793101.360.66102.36101.920.66
2428804-428804101.181101.74
3431369-431369101.786102.37
4427017-427017100.759101.30
5425820-425820100.477101.03
6433021-433021102.176102.73
45min1430949-430949101.687101.270.59102.43102.000.60
2428069-428069101.008101.73
3431025-431025101.705102.46
4426827-426827100.715101.42
5426108-426108100.545101.26
6432201-432201101.983102.71
60min1430708-430708101.630101.160.59102.54102.050.60
2427417-427417100.854101.75
3430364-430364101.549102.47
4426310-426310100.593101.46
5425763-425763100.464101.35
6431613-431613101.844102.74
极限1429078-429078101.246100.920.56102.32101.990.57
2426169-426169100.559101.62
3430122-430122101.492102.58
4425673-425673100.442101.48
5424975-424975100.278101.33
6430287-430287101.531102.59
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)1.5补液体积(ml)1.5
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%
111.314742124735764729124725584730954732710.14
211.344741504738714740100.05
单位质量响应值RSD%判断
41845.3641799.820.08数据可信
中间条件3月-供试品溶液-2024031021批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1431647-43164788.19289.0810.0888.1989.0810.08
2489988-489988100.112100.11
3419309-41930985.67185.67
4482693-48269398.62198.62
5372907-37290776.19076.19
6419486-41948685.70785.71
10min1502058-502058102.578101.872.65102.72102.022.66
2510711-510711104.346104.51
3490412-490412100.198100.34
4512558-512558104.723104.89
5477407-47740797.54197.67
6498537-498537101.858102.00
15min1506969-506969103.581103.061.44103.90103.381.45
2510486-510486104.300104.64
3497145-497145101.574101.88
4512687-512687104.749105.09
5494629-494629101.060101.35
6504592-504592103.095103.41
20min1509330-509330104.064103.350.99104.55103.841.01
2509848-509848104.169104.68
3500132-500132102.184102.66
4511430-511430104.493105.01
5500387-500387102.236102.69
6503975-503975102.969103.45
30min1508071-508071103.806103.220.81104.47103.880.82
2508478-508478103.889104.58
3499998-499998102.157102.81
4509828-509828104.165104.85
5502576-502576102.684103.31
6502329-502329102.633103.29
45min1506427-506427103.470103.060.85104.31103.890.86
2507904-507904103.772104.63
3499043-499043101.962102.78
4509836-509836104.167105.03
5501068-501068102.375103.17
6502234-502234102.614103.44
60min1506388-506388103.462102.830.87104.47103.840.88
2506630-506630103.512104.55
3497626-497626101.672102.66
4508262-508262103.845104.88
5500755-500755102.312103.28
6500171-500171102.192103.19
极限1504144-504144103.004102.580.94104.19103.760.95
2506781-506781103.543104.75
3495865-495865101.312102.47
4507426-507426103.674104.88
5499287-499287102.012103.15
6499058-499058101.965103.13
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)1.5补液体积(ml)1.5
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%
110.694091524089634082784079144084714085560.13
210.734097454095214096330.04
单位质量响应值RSD%判断
38218.5238176.420.08数据可信
中间条件3月-供试品溶液-2024031021批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1197175-19717546.45846.9125.3446.4646.9125.33
2295658-29565869.66269.66
3174426-17442641.09841.10
4201523-20152347.48247.48
5154013-15401336.28836.29
6171790-17179040.47740.48
10min1400742-40074294.42296.072.9094.5096.152.91
2419958-41995898.95099.07
3398541-39854193.90393.97
4423386-42338699.75799.84
5409003-40900396.36896.43
6394784-39478493.01893.09
15min1436186-436186102.773100.881.74103.01101.121.74
2425887-425887100.347100.63
3420159-42015998.99799.22
4438590-438590103.340103.58
5424634-424634100.051100.27
6423510-42351099.786100.01
20min1441031-441031103.915101.561.58104.32101.961.58
2425816-425816100.330100.78
3428264-428264100.907101.30
4438290-438290103.269103.69
5425892-425892100.348100.74
6426829-426829100.568100.96
30min1439799-439799103.624101.571.45104.20102.151.44
2425494-425494100.254100.87
3429472-429472101.191101.75
4438061-438061103.215103.80
5427115-427115100.636101.19
6426645-426645100.525101.08
45min1438519-438519103.323101.391.40104.07102.131.39
2424581-424581100.039100.82
3428769-428769101.026101.75
4437112-437112102.991103.75
5425868-425868100.342101.06
6426972-426972100.602101.33
60min1438238-438238103.257101.181.42104.18102.091.41
2423633-42363399.815100.76
3427879-427879100.816101.71
4435710-435710102.661103.59
5425612-425612100.282101.17
6425398-425398100.231101.12
极限1436253-436253102.789100.881.38103.89101.971.37
2423467-42346799.776100.89
3425878-425878100.344101.41
4435092-435092102.515103.62
5424115-42411599.929100.99
6424232-42423299.957101.02
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)1.5补液体积(ml)1.5
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%
111.314729724725854723204725994727504726450.06
211.344732524736574734540.07
单位质量响应值RSD%判断
41790.0141750.790.07数据可信
中间条件3月-供试品溶液-CLB05410批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1427557-42755787.46587.112.0687.4787.112.06
2414299-41429984.75384.75
3415425-41542584.98384.98
4432421-43242188.46088.46
5433655-43365588.71388.71
6431518-43151888.27688.28
10min1464240-46424094.96997.821.7095.1297.971.69
2486853-48685399.59599.74
3483095-48309598.82798.97
4482729-48272998.75298.90
5477499-47749997.68297.83
6474639-47463997.09797.24
15min1466573-46657395.44799.742.4695.75100.042.46
2491911-491911100.630100.94
3501341-501341102.559102.87
4493456-493456100.946101.26
5489664-489664100.170100.48
6482300-48230098.66498.97
20min1468094-46809495.75899.972.3296.22100.442.32
2491962-491962100.641101.12
3500507-500507102.389102.87
4496094-496094101.486101.97
5489907-489907100.220100.70
6485436-48543699.30699.78
30min1465344-46534495.19599.732.4995.82100.372.48
2490631-490631100.368101.01
3499991-499991102.283102.93
4495600-495600101.385102.03
5488754-48875499.984100.63
6484785-48478599.17299.81
45min1465161-46516195.15899.542.4395.94100.352.43
2490467-490467100.335101.14
3499930-499930102.271103.09
4492234-492234100.696101.51
5488437-48843799.919100.73
6483337-48333798.87699.68
60min1465930-46593095.31599.432.3096.26100.402.30
2489458-489458100.128101.11
3499155-499155102.112103.10
4491108-491108100.466101.45
5487370-48737099.701100.68
6483201-48320198.84899.82
极限1462269-46226994.56699.022.5795.67100.162.56
2488992-488992100.033101.18
3497617-497617101.797102.96
4491009-491009100.446101.60
5485993-48599399.419100.56
6478273-47827397.84098.97
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)1.5补液体积(ml)1.5
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%
110.694083924083434084204084904086494084590.03
210.734090984095764093370.09
单位质量响应值RSD%判断
38209.4538148.840.12数据可信
中间条件3月-供试品溶液-CLB05410批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1223600-22360052.70943.3517.1052.7143.3517.10
2212478-21247850.08850.09
3139189-13918932.81132.81
4162789-16278938.37438.37
5175606-17560641.39641.40
6189639-18963944.70444.70
10min1414098-41409897.61691.924.5997.7091.994.59
2410810-41081096.84196.92
3383899-38389990.49790.55
4381580-38158089.95090.01
5373495-37349588.04488.11
6375826-37582688.59488.67
15min1433845-433845102.271103.290.77102.52103.510.76
2439299-439299103.556103.80
3441850-441850104.158104.36
4441105-441105103.982104.20
5438331-438331103.328103.54
6434476-434476102.419102.64
20min1434725-434725102.478103.560.77102.90103.960.76
2438373-438373103.338103.76
3441899-441899104.169104.55
4444108-444108104.690105.08
5439741-439741103.661104.05
6437119-437119103.042103.44
30min1431943-431943101.822103.300.95102.41103.860.93
2437247-437247103.073103.66
3441509-441509104.077104.63
4443691-443691104.592105.15
5438664-438664103.407103.97
6436124-436124102.808103.37
45min1432048-432048101.847103.130.81102.61103.870.79
2437157-437157103.051103.81
3441147-441147103.992104.72
4440862-440862103.925104.66
5438542-438542103.378104.11
6435089-435089102.564103.30
60min1432584-432584101.973103.000.68102.90103.910.67
2436184-436184102.822103.76
3440328-440328103.799104.70
4439994-439994103.720104.63
5437340-437340103.095104.00
6435191-435191102.588103.49
极限1428926-428926101.111102.561.01102.21103.641.00
2435538-435538102.670103.77
3439282-439282103.552104.62
4439546-439546103.615104.70
5436366-436366102.865103.94
6430707-430707101.531102.61
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)1.5补液体积(ml)1.5
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%
111.314729124726994727984728954726524727910.03
211.344725444743554734500.28
单位质量响应值RSD%判断
41802.9241750.440.09数据可信
中间条件3月-供试品溶液-2024030821批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1384996-38499678.74782.163.9778.7582.163.97
2411070-41107084.08084.08
3379209-37920977.56377.56
4405356-40535682.91182.91
5410418-41041883.94783.95
6419165-41916585.73685.74
10min1503084-503084102.900100.532.91103.03100.672.90
2501119-501119102.498102.64
3499182-499182102.102102.23
4466161-46616195.34895.49
5483237-48323798.84198.98
6496185-496185101.489101.63
15min1504876-504876103.267102.281.62103.57102.581.62
2509934-509934104.301104.61
3503777-503777103.042103.34
4487882-48788299.791100.09
5493533-493533100.947101.25
6500246-500246102.320102.63
20min1501888-501888102.656102.351.24103.13102.821.24
2509421-509421104.197104.68
3503306-503306102.946103.42
4490966-490966100.422100.89
5497146-497146101.686102.16
6499597-499597102.187102.67
30min1501025-501025102.479102.131.08103.13102.781.08
2507858-507858103.877104.54
3501832-501832102.644103.29
4492793-492793100.795101.43
5496216-496216101.496102.14
6496105-496105101.473102.13
45min1499229-499229102.112101.941.16102.93102.751.16
2507917-507917103.889104.72
3500833-500833102.440103.25
4491148-491148100.459101.26
5494872-494872101.221102.03
6496211-496211101.495102.32
60min1501274-501274102.530101.911.19103.52102.901.19
2506488-506488103.597104.60
3499739-499739102.216103.20
4489517-489517100.125101.09
5494086-494086101.060102.04
6498327-498327101.927102.92
极限1499754-499754102.219101.621.10103.38102.771.10
2504524-504524103.195104.37
3497403-497403101.738102.89
4488425-48842599.902101.04
5493923-493923101.027102.18
6496842-496842101.624102.78
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)1.5补液体积(ml)1.5
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%
110.694085664083464086024087294084044085290.04
210.734083614081634082620.04
单位质量响应值RSD%判断
38216.0038048.650.32数据可信
中间条件3月-供试品溶液-2024030821批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1197700-19770046.66149.716.1346.6649.716.13
2227133-22713353.60853.61
3197997-19799746.73246.73
4204339-20433948.22848.23
5212083-21208350.05650.06
6224416-22441652.96752.97
10min1434622-434622102.58097.732.93102.6697.822.93
2419905-41990599.10799.20
3413387-41338797.56897.65
4411388-41138897.09697.18
5404552-40455295.48395.57
6400620-40062094.55594.64
15min1440097-440097103.872101.861.31104.12102.111.31
2437389-437389103.233103.49
3428751-428751101.194101.43
4427844-427844100.980101.22
5427525-427525100.905101.15
6427943-427943101.004101.25
20min1437719-437719103.311102.041.12103.73102.451.12
2439181-439181103.656104.08
3430481-430481101.603102.01
4428342-428342101.098101.51
5429617-429617101.399101.81
6428634-428634101.167101.58
30min1436533-436533103.031101.891.13103.63102.481.14
2438683-438683103.539104.14
3429796-429796101.441102.02
4429979-429979101.484102.06
5429475-429475101.365101.95
6425798-425798100.497101.08
45min1435508-435508102.789101.761.08103.55102.521.09
2438429-438429103.479104.25
3429023-429023101.259102.01
4428650-428650101.171101.92
5428540-428540101.145101.89
6426807-426807100.736101.49
60min1437067-437067103.157101.711.14104.09102.631.14
2437367-437367103.228104.17
3428449-428449101.123102.04
4427279-427279100.847101.76
5427654-427654100.935101.85
6427816-427816100.974101.89
极限1435642-435642102.821101.411.16103.93102.511.17
2436506-436506103.025104.14
3426226-426226100.598101.68
4425982-425982100.541101.63
5427134-427134100.813101.90
6426560-426560100.677101.76
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