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)0补液体积(ml)0
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%
110.924582084583834583504583904582604583180.02
210.774561384561754561560.01
单位质量响应值RSD%判断
41970.5142354.320.65数据可信
加速3月-供试品溶液-2024040821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%
5min1484936-48493698.28385.7213.3298.2885.7213.32
2348093-34809370.54970.55
3469964-46996495.24895.25
4451268-45126891.45991.46
5364717-36471773.91873.92
6418624-41862484.84384.84
10min1501385-501385101.61796.875.22101.6296.875.22
2460207-46020793.27193.27
3496136-496136100.553100.55
4492104-49210499.73699.74
5436683-43668388.50388.50
6481287-48128797.54397.54
15min1501849-501849101.71199.202.49101.7199.202.49
2481933-48193397.67497.67
3497415-497415100.812100.81
4499022-499022101.138101.14
5470382-47038295.33395.33
6486176-48617698.53498.53
20min1499452-499452101.22599.731.63101.2299.721.63
2491039-49103999.52099.52
3497281-497281100.785100.78
4499023-499023101.138101.14
5480003-48000397.28397.28
6485542-48554298.40698.41
30min1499580-499580101.251100.011.46101.25100.011.46
2498491-498491101.030101.03
3495793-495793100.483100.48
4498224-498224100.976100.98
5484544-48454498.20398.20
6484104-48410498.11498.11
45min1498276-498276100.98799.931.47100.9999.931.47
2499956-499956101.327101.33
3495429-495429100.410100.41
4496840-496840100.696100.70
5484252-48425298.14498.14
6483682-48368298.02998.03
60min1496676-496676100.66299.801.57100.6699.801.57
2501453-501453101.630101.63
3494169-494169100.154100.15
4496179-496179100.562100.56
5482538-48253897.79797.80
6483372-48337297.96697.97
极限1495273-495273100.37899.741.68100.3899.741.68
2502918-502918101.927101.93
3493257-49325799.96999.97
4496559-496559100.639100.64
5481570-48157097.60197.60
6483030-48303097.89797.90
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)0补液体积(ml)0
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%
110.894087484084154084934090074083944086110.07
210.854073604074664074130.02
单位质量响应值RSD%判断
37521.6737549.590.06数据可信
加速3月-供试品溶液-2024040821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%
5min1276390-27639066.27149.3023.0366.2749.3023.03
2161230-16123038.65838.66
3249649-24964959.85959.86
4179833-17983343.11943.12
5200886-20088648.16748.17
6165636-16563639.71539.71
10min1415342-41534299.58796.124.8699.5996.124.86
2401665-40166596.30896.31
3411533-41153398.67498.67
4362568-36256886.93486.93
5410513-41051398.43098.43
6403618-40361896.77696.78
15min1430051-430051103.114101.411.40103.11101.411.40
2423003-423003101.424101.42
3419748-419748100.644100.64
4413116-41311699.05499.05
5425851-425851102.107102.11
6425906-425906102.120102.12
20min1429849-429849103.066101.990.76103.07101.990.76
2424087-424087101.684101.68
3421079-421079100.963100.96
4423724-423724101.597101.60
5425113-425113101.930101.93
6428225-428225102.676102.68
30min1429386-429386102.955101.980.70102.95101.980.70
2426819-426819102.339102.34
3421132-421132100.976100.98
4423453-423453101.532101.53
5424049-424049101.675101.68
6427009-427009102.385102.38
45min1427945-427945102.609101.800.62102.61101.800.62
2425139-425139101.937101.94
3421204-421204100.993100.99
4422629-422629101.335101.33
5423402-423402101.520101.52
6426989-426989102.380102.38
60min1426492-426492102.261101.530.55102.26101.530.54
2424078-424078101.682101.68
3420480-420480100.819100.82
4422120-422120101.213101.21
5422061-422061101.199101.20
6425450-425450102.011102.01
极限1425420-425420102.004101.380.59102.00101.380.58
2424404-424404101.760101.76
3419712-419712100.635100.64
4421144-421144100.979100.98
5421043-421043100.954100.95
6425126-425126101.933101.93
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)0补液体积(ml)0
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%
110.924570924574254572614573344573994573020.03
210.774568934569664569300.02
单位质量响应值RSD%判断
41877.4742426.180.93数据可信
加速3月-供试品溶液-2024040921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%
5min1407218-40721882.55487.819.2682.5587.819.26
2462168-46216893.69493.69
3420657-42065785.27985.28
4484105-48410598.14198.14
5374230-37423075.86775.87
6450397-45039791.30891.31
10min1465083-46508394.28596.153.9094.2896.153.90
2482985-48298597.91497.91
3473517-47351795.99595.99
4497921-497921100.942100.94
5443895-44389589.99089.99
6482356-48235697.78797.79
15min1487396-48739698.80898.182.5598.8198.182.55
2482692-48269297.85597.85
3494035-494035100.154100.15
4497216-497216100.799100.80
5462308-46230893.72293.72
6482258-48225897.76797.77
20min1487700-48770098.87098.202.5498.8798.202.54
2482014-48201497.71797.72
3493986-493986100.144100.14
4496634-496634100.681100.68
5462087-46208793.67893.68
6484100-48410098.14098.14
30min1485798-48579898.48498.042.2898.4898.042.29
2481819-48181997.67897.68
3491031-49103199.54599.55
4495831-495831100.518100.52
5463751-46375194.01594.01
6483421-48342198.00398.00
45min1484528-48452898.22797.802.5898.2397.802.57
2480357-48035797.38197.38
3492893-49289399.92399.92
4494499-494499100.248100.25
5459958-45995893.24693.25
6482407-48240797.79797.80
60min1484473-48447398.21697.422.6198.2297.422.61
2479458-47945897.19997.20
3490568-49056899.45199.45
4493734-493734100.093100.09
5458744-45874493.00093.00
6476180-47618096.53596.53
极限1482636-48263697.84397.352.5297.8497.352.52
2477625-47762596.82896.83
3489748-48974899.28599.29
4492324-49232499.80799.81
5458316-45831692.91392.91
6480463-48046397.40397.40
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)0补液体积(ml)0
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%
110.894080294084584083514082634083344082870.04
210.854079114078764078940.01
单位质量响应值RSD%判断
37491.9237593.920.20数据可信
加速3月-供试品溶液-2024040921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%
5min186191-8619120.66238.6951.9720.6638.6951.97
2238896-23889657.27057.27
3114954-11495427.55727.56
4282472-28247267.71667.72
579775-7977519.12419.12
6166019-16601939.79939.80
10min1285931-28593168.54583.7519.3668.5583.7519.36
2425314-425314101.959101.96
3298199-29819971.48671.49
4426656-426656102.281102.28
5286861-28686168.76868.77
6373216-37321689.47089.47
15min1408781-40878197.995100.322.1198.00100.322.11
2427718-427718102.535102.54
3411475-41147598.64198.64
4427054-427054102.376102.38
5411329-41132998.60698.61
6424413-424413101.743101.74
20min1426104-426104102.148101.730.49102.15101.730.49
2426267-426267102.187102.19
3422568-422568101.301101.30
4425685-425685102.048102.05
5421266-421266100.988100.99
6424182-424182101.687101.69
30min1427864-427864102.570101.850.46102.57101.840.46
2425704-425704102.052102.05
3422237-422237101.221101.22
4424953-424953101.872101.87
5424788-424788101.833101.83
6423515-423515101.528101.53
45min1426850-426850102.327101.550.50102.33101.550.50
2424786-424786101.832101.83
3421393-421393101.019101.02
4424233-424233101.700101.70
5421620-421620101.073101.07
6422676-422676101.326101.33
60min1426502-426502102.244101.360.60102.24101.360.59
2423990-423990101.641101.64
3419474-419474100.559100.56
4423117-423117101.432101.43
5420593-420593100.827100.83
6423122-423122101.433101.43
极限1425660-425660102.042101.080.58102.04101.080.57
2422450-422450101.272101.27
3419100-419100100.469100.47
4422279-422279101.231101.23
5419505-419505100.566100.57
6420839-420839100.886100.89
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)0补液体积(ml)0
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%
110.924728934725614722594722414741844728280.17
210.774724934719754722340.08
单位质量响应值RSD%判断
43299.2743847.170.89数据可信
加速3月-供试品溶液-2024041021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%
5min1387131-38713175.92284.9811.7475.9284.9811.74
2485702-48570295.25395.25
3451579-45157988.56188.56
4478078-47807893.75893.76
5439625-43962586.21686.22
6357934-35793470.19670.20
10min1453812-45381288.99993.735.1889.0093.735.17
2513829-513829100.769100.77
3468244-46824491.82991.83
4500531-50053198.16198.16
5477228-47722893.59193.59
6453897-45389789.01589.02
15min1481201-48120194.37095.903.4194.3795.903.41
2515365-515365101.070101.07
3468601-46860191.89991.90
4501590-50159098.36998.37
5483570-48357094.83594.83
6483741-48374194.86894.87
20min1487307-48730795.56796.163.2795.5796.163.27
2515763-515763101.148101.15
3468901-46890191.95891.96
4500246-50024698.10598.11
5483279-48327994.77894.78
6486354-48635495.38195.38
30min1486287-48628795.36795.963.2695.3795.963.26
2514070-514070100.816100.82
3467153-46715391.61591.62
4499512-49951297.96197.96
5483039-48303994.73094.73
6485862-48586295.28495.28
45min1484437-48443795.00595.703.3395.0095.703.33
2513143-513143100.634100.63
3465405-46540591.27291.27
4498636-49863697.78997.79
5481889-48188994.50594.50
6484324-48432494.98294.98
60min1484640-48464095.04495.442.9695.0495.442.96
2506710-50671099.37399.37
3465240-46524091.24091.24
4498211-49821197.70697.71
5481144-48114494.35994.36
6484137-48413794.94694.95
极限1484426-48442695.00295.423.3295.0095.423.32
2511665-511665100.344100.34
3463716-46371690.94190.94
4496220-49622097.31597.32
5480530-48053094.23894.24
6482800-48280094.68494.68
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)0补液体积(ml)0
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%
110.894059964053094055034055684070494058850.18
210.854053494048954051220.08
单位质量响应值RSD%判断
37271.3537338.430.13数据可信
加速3月-供试品溶液-2024041021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%
5min1122593-12259329.57646.0745.5929.5846.0745.59
2229588-22958855.38955.39
3283623-28362368.42668.43
4283356-28335668.36168.36
5148620-14862035.85535.86
677859-7785918.78418.78
10min1306943-30694374.05286.5420.3174.0586.5420.32
2406657-40665798.10898.11
3419188-419188101.131101.13
4415204-415204100.170100.17
5366488-36648888.41788.42
6237688-23768857.34457.34
15min1419581-419581101.226100.374.65101.23100.374.65
2430362-430362103.827103.83
3420179-420179101.370101.37
4429600-429600103.643103.64
5418448-418448100.953100.95
6378093-37809391.21791.22
20min1425655-425655102.692102.191.58102.69102.191.57
2432132-432132104.254104.25
3420037-420037101.336101.34
4429629-429629103.650103.65
5418888-418888101.059101.06
6415018-415018100.125100.13
30min1424220-424220102.345102.301.16102.35102.301.16
2430648-430648103.896103.90
3418675-418675101.008101.01
4428454-428454103.367103.37
5418795-418795101.037101.04
6423426-423426102.154102.15
45min1422364-422364101.898101.921.20101.90101.921.20
2429412-429412103.598103.60
3417493-417493100.722100.72
4427222-427222103.070103.07
5416879-416879100.574100.57
6421458-421458101.679101.68
60min1422450-422450101.918101.841.17101.92101.841.17
2428677-428677103.421103.42
3416910-416910100.582100.58
4426796-426796102.967102.97
5416913-416913100.583100.58
6421116-421116101.597101.60
极限1422062-422062101.825101.601.16101.82101.601.16
2427665-427665103.176103.18
3415875-415875100.332100.33
4425151-425151102.570102.57
5415659-415659100.280100.28
6420299-420299101.399101.40
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)0补液体积(ml)0
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%
110.924730544730474728584728364728754729340.03
210.774734024731864732940.04
单位质量响应值RSD%判断
43308.9743945.591.04数据可信
中间条件3月-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%
5min1424048-42404883.06088.043.8283.0688.043.82
2440299-44029986.24386.24
3445755-44575587.31187.31
4468703-46870391.80691.81
5449693-44969388.08388.08
6468304-46830491.72891.73
10min1494049-49404996.77196.211.6096.7796.211.60
2505381-50538198.99198.99
3485048-48504895.00895.01
4484304-48430494.86294.86
5487647-48764795.51795.52
6490668-49066896.10996.11
15min1497007-49700797.35096.821.9597.3596.821.95
2512086-512086100.304100.30
3491686-49168696.30896.31
4485039-48503995.00695.01
5487968-48796895.58095.58
6491872-49187296.34596.34
20min1496735-49673597.29796.691.9297.3096.691.92
2510797-510797100.051100.05
3492818-49281896.53096.53
4484259-48425994.85394.85
5487259-48725995.44195.44
6489871-48987195.95395.95
30min1495915-49591597.13696.551.9697.1496.561.96
2510162-51016299.92799.93
3492964-49296496.55896.56
4482987-48298794.60494.60
5486095-48609595.21395.21
6489534-48953495.88795.89
45min1495807-49580797.11596.401.9597.1296.401.95
2508850-50885099.67099.67
3491834-49183496.33796.34
4481730-48173094.35894.36
5485028-48502895.00495.00
6489697-48969795.91995.92
60min1493835-49383596.72996.071.9296.7396.071.92
2507174-50717499.34299.34
3490253-49025396.02796.03
4481117-48111794.23894.24
5483216-48321694.64994.65
6487106-48710695.41195.41
极限1493453-49345396.65495.942.1696.6595.942.16
2508116-50811699.52699.53
3490937-49093796.16196.16
4478010-47801093.62993.63
5482651-48265194.53894.54
6485613-48561395.11995.12
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)0补液体积(ml)0
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%
110.894056784057454056194055714055584056340.02
210.854080554080124080340.01
单位质量响应值RSD%判断
37248.3037606.820.68数据可信
中间条件3月-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%
5min1136460-13646032.81547.0736.8832.8147.0836.88
2136055-13605532.71732.72
3221466-22146653.25653.26
4260822-26082262.72062.72
5127151-12715130.57630.58
6292579-29257970.35670.36
10min1369931-36993188.95794.785.8388.9694.785.83
2363822-36382287.48887.49
3414089-41408999.57699.58
4408026-40802698.11898.12
5391776-39177694.21094.21
6417323-417323100.354100.35
15min1414664-41466499.714101.010.7899.71101.010.78
2419475-419475100.871100.87
3424581-424581102.099102.10
4420576-420576101.136101.14
5421673-421673101.400101.40
6419289-419289100.826100.83
20min1421360-421360101.324101.310.54101.32101.310.55
2423167-423167101.759101.76
3423653-423653101.876101.88
4420113-420113101.025101.02
5422007-422007101.480101.48
6417446-417446100.383100.38
30min1425247-425247102.259101.350.71102.26101.350.71
2423034-423034101.727101.73
3422896-422896101.694101.69
4419357-419357100.843100.84
5421267-421267101.302101.30
6416929-416929100.259100.26
45min1425721-425721102.373101.190.76102.37101.190.76
2421775-421775101.424101.42
3422131-422131101.510101.51
4418180-418180100.560100.56
5420391-420391101.091101.09
6416716-416716100.208100.21
60min1425076-425076102.218100.880.85102.22100.880.85
2420432-420432101.101101.10
3420918-420918101.218101.22
4416956-416956100.265100.27
5418877-418877100.727100.73
6414809-41480999.74999.75
极限1424202-424202102.008100.620.96102.01100.620.96
2420861-420861101.204101.20
3419506-419506100.879100.88
4414960-41496099.78599.79
5417858-417858100.482100.48
6413223-41322399.36899.37
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