瑞舒伐他汀钙依折麦布片项目信息
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%
111.194759964760254765434766004765444763420.07
211.224787834777034782430.16
单位质量响应值RSD%判断
42568.5442624.150.10数据可信
中间条件12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%
5min1448656-44865690.00283.1213.4590.0083.1213.44
2382090-38209076.64876.65
3454396-45439691.15391.15
4464542-46454293.18993.19
5417856-41785683.82383.82
6318665-31866563.92563.93
10min1491826-49182698.66298.321.3098.8198.451.29
2491536-49153698.60498.73
3477716-47771695.83195.98
4491185-49118598.53398.69
5492074-49207498.71298.85
6496282-49628299.55699.66
15min1494068-49406899.11299.342.4199.4399.642.39
2493786-49378699.05599.35
3479605-47960596.21096.52
4490774-49077498.45198.77
5496912-49691299.68299.99
6516141-516141103.540103.81
20min1492264-49226498.75099.212.2799.2399.682.25
2492490-49249098.79599.25
3480862-48086296.46296.93
4490957-49095798.48898.97
5496005-49600599.50099.97
6514875-514875103.286103.73
30min1492125-49212598.72299.342.2799.3799.982.24
2493783-49378399.05499.68
3481423-48142396.57597.21
4491663-49166398.62999.28
5496858-49685899.671100.31
6515468-515468103.405104.02
45min1491486-49148698.59499.212.2799.40100.012.25
2493259-49325998.94999.74
3481109-48110996.51297.31
4489180-48918098.13198.94
5497912-49791299.883100.69
6514380-514380103.186103.98
60min1491106-49110698.51798.932.2699.4999.892.24
2489196-48919698.13499.09
3480081-48008196.30697.26
4489227-48922798.14199.12
5496075-49607599.514100.48
6513237-513237102.957103.92
极限1489390-48939098.17398.782.4799.3199.912.44
2489263-48926398.14899.26
3477614-47761495.81196.93
4488213-48821397.93799.08
5495999-49599999.499100.63
6513994-513994103.109104.24
瑞舒伐他汀钙依折麦布片项目信息
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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
111.124408614418464416294416404416504415250.09
211.144417214414354415780.05
单位质量响应值RSD%判断
39705.4939638.960.12数据可信
中间条件12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%
5min1254449-25444957.58045.8230.9857.5845.8230.98
2178194-17819440.32440.32
3230886-23088652.24852.25
4258516-25851658.50058.50
5201969-20196945.70445.70
690982-9098220.58820.59
10min1411133-41113393.03689.675.4293.1389.755.44
2380029-38002985.99886.06
3391827-39182788.66788.75
4422978-42297895.71795.81
5406623-40662392.01692.09
6365042-36504282.60682.64
15min1427986-42798696.85095.331.8297.1095.561.83
2410303-41030392.84893.06
3416730-41673094.30394.54
4431068-43106897.54797.80
5418386-41838694.67794.91
6423122-42312295.74995.92
20min1430163-43016397.34295.751.4197.7596.131.42
2416426-41642694.23494.60
3418488-41848894.70095.09
4429308-42930897.14997.57
5418941-41894194.80395.19
6425401-42540196.26596.60
30min1433338-43333898.06196.221.4198.6496.761.42
2419231-41923194.86995.39
3419592-41959294.95095.50
4429618-42961897.21997.80
5421145-42114595.30295.85
6428251-42825196.91097.40
45min1432239-43223997.81296.041.3998.5596.741.40
2418379-41837994.67695.36
3420443-42044395.14395.85
4429720-42972097.24297.99
5419156-41915694.85295.56
6426417-42641796.49597.15
60min1428881-42888197.05295.821.2597.9596.681.26
2416076-41607694.15594.99
3420540-42054095.16596.03
4429382-42938297.16698.07
5420561-42056195.17096.03
6425249-42524996.23097.04
极限1430088-43008897.32596.061.0498.3997.081.06
2419390-41939094.90595.90
3421357-42135795.35096.38
4429329-42932997.15498.22
5422068-42206895.51196.53
6424677-42467796.10197.08
瑞舒伐他汀钙依折麦布片项目信息
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%
111.194772164769514762544784544780254773800.19
211.224763914745084754500.29
单位质量响应值RSD%判断
42661.3042375.220.48数据可信
中间条件12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%
5min1487664-48766498.00892.0811.7898.0192.0811.77
2501418-501418100.772100.77
3457566-45756691.95991.96
4478750-47875096.21696.22
5471420-47142094.74394.74
6352332-35233270.80970.81
10min1514072-514072103.315101.921.93103.48102.071.94
2519821-519821104.470104.64
3511940-511940102.887103.04
4499548-499548100.396100.56
5503321-503321101.154101.31
6493949-49394999.27199.39
15min1513913-513913103.283102.271.57103.62102.601.58
2517141-517141103.932104.27
3516957-516957103.895104.22
4500280-500280100.543100.87
5503652-503652101.221101.55
6501333-501333100.755101.04
20min1514590-514590103.419102.081.98103.93102.581.98
2518593-518593104.224104.74
3517745-517745104.053104.55
4497141-49714199.912100.41
5500072-500072100.501101.00
6499518-499518100.390100.84
30min1512110-512110102.921102.091.74103.60102.761.74
2517882-517882104.081104.77
3516631-516631103.829104.50
4496611-49661199.806100.47
5503974-503974101.286101.95
6500739-500739100.635101.25
45min1509250-509250102.346101.491.79103.20102.321.80
2516028-516028103.708104.57
3512992-512992103.098103.94
4493281-49328199.13799.96
5499927-499927100.472101.30
6498528-498528100.191100.98
60min1511437-511437102.785101.591.91103.81102.601.91
2515287-515287103.559104.59
3515488-515488103.600104.62
4495561-49556199.595100.59
5499834-499834100.454101.45
6495466-49546699.576100.53
极限1510494-510494102.596101.371.81103.79102.551.82
2514438-514438103.389104.60
3512246-512246102.948104.14
4492323-49232398.944100.10
5499169-499169100.320101.49
6497825-497825100.050101.17
瑞舒伐他汀钙依折麦布片项目信息
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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
111.124428264413154403734410524419484415030.22
211.144415774409934412850.10
单位质量响应值RSD%判断
39703.5139612.660.17数据可信
中间条件12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%
5min1276055-27605562.49148.1832.2262.4948.1832.22
2293240-29324066.38266.38
3182362-18236241.28241.28
4239763-23976354.27654.28
5170781-17078138.66038.66
6114774-11477425.98225.98
10min1420417-42041795.17194.703.6095.2894.783.62
2431973-43197397.78797.90
3396817-39681789.82989.90
4434352-43435298.32598.42
5422467-42246795.63595.70
6404061-40406191.46891.51
15min1435161-43516198.50999.270.7298.7799.510.72
2441821-441821100.016100.29
3440021-44002199.60999.83
4438550-43855099.27699.53
5434421-43442198.34198.56
6441272-44127299.892100.09
20min1435178-43517898.51299.210.7798.9499.610.77
2442602-442602100.193100.63
3440090-44009099.624100.01
4438182-43818299.19299.61
5433641-43364198.16598.55
6439852-43985299.57199.93
30min1434197-43419798.29099.140.8198.8899.710.80
2441175-44117599.870100.48
3440315-44031599.675100.23
4437065-43706598.94099.52
5433617-43361798.15998.71
6441443-44144399.931100.46
45min1432849-43284997.98598.950.9998.7499.690.98
2441465-44146599.936100.71
3440270-44027099.665100.38
4436056-43605698.71199.46
5431502-43150297.68098.40
6440648-44064899.751100.45
60min1430246-43024697.39698.590.7498.3199.490.74
2438063-43806399.166100.11
3438742-43874299.319100.20
4435854-43585498.66599.58
5433277-43327798.08298.96
6436966-43696698.91799.78
极限1430634-43063497.48498.471.0298.5699.531.01
2440105-44010599.628100.73
3438194-43819499.195100.24
4432302-43230297.86198.94
5430245-43024597.39698.44
6438384-43838499.238100.26
瑞舒伐他汀钙依折麦布片项目信息
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%
111.194767444778744775054778274771554774210.10
211.224756314755024755660.02
单位质量响应值RSD%判断
42664.9742385.560.47数据可信
中间条件12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%
5min1490349-49034998.53189.799.1398.5389.799.12
2407678-40767881.91981.92
3413096-41309683.00883.01
4478120-47812096.07496.07
5483034-48303497.06197.06
6408760-40876082.13682.14
10min1505097-505097101.494100.791.52101.66100.941.52
2507155-507155101.908102.04
3504605-504605101.396101.53
4500343-500343100.539100.70
5505514-505514101.578101.74
6486786-48678697.81597.95
15min1504429-504429101.360101.571.33101.69101.891.32
2515586-515586103.602103.91
3511003-511003102.681102.99
4499795-499795100.429100.76
5504019-504019101.278101.61
6498097-498097100.088100.39
20min1504283-504283101.331101.521.17101.83102.001.16
2514207-514207103.325103.80
3509494-509494102.378102.86
4497310-49731099.930100.42
5502965-502965101.066101.57
6502972-502972101.067101.53
30min1502764-502764101.026101.311.27101.70101.961.26
2513980-513980103.279103.93
3509715-509715102.422103.07
4497110-49711099.890100.55
5500825-500825100.636101.30
6500561-500561100.583101.22
45min1500317-500317100.534101.111.36101.37101.941.35
2512890-512890103.060103.88
3510758-510758102.632103.45
4496607-49660799.789100.62
5499477-499477100.365101.20
6499144-499144100.298101.10
60min1498474-498474100.164100.901.26101.17101.901.25
2512340-512340102.950103.95
3507348-507348101.947102.94
4496081-49608199.683100.68
5498768-498768100.223101.23
6499867-499867100.444101.41
极限1500416-500416100.554100.781.43101.73101.941.42
2514778-514778103.440104.61
3504113-504113101.297102.46
4496956-49695699.859101.02
5496536-49653699.774100.94
6496480-49648099.763100.90
瑞舒伐他汀钙依折麦布片项目信息
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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
111.124419304420484410104421844424454419230.13
211.144382114394574388340.21
单位质量响应值RSD%判断
39741.2839392.640.63数据可信
中间条件12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%
5min1290765-29076565.97452.3535.0165.9752.3535.01
2135590-13559030.76530.77
3175675-17567539.86039.86
4297094-29709467.41067.41
5320895-32089572.81172.81
6164369-16436937.29537.30
10min1408716-40871692.73790.404.1592.8590.494.18
2385022-38502287.36187.41
3401350-40135091.06691.13
4401979-40197991.20891.32
5419707-41970795.23195.35
6373796-37379684.81484.88
15min1427551-42755197.01196.161.2497.2896.401.24
2427433-42743396.98497.18
3426496-42649696.77196.99
4415522-41552294.28194.55
5426884-42688496.85997.14
6418842-41884295.03595.24
20min1427100-42710096.90896.801.0097.3397.200.98
2431163-43116397.83098.19
3427485-42748596.99697.38
4418516-41851694.96195.38
5427421-42742196.98197.42
6428057-42805797.12597.49
30min1425839-42583996.62296.901.2597.2197.461.22
2433644-43364498.39398.91
3429342-42934297.41797.96
4417640-41764094.76295.34
5427141-42714196.91897.52
6428812-42881297.29797.82
45min1427292-42729296.95297.011.2397.7097.741.20
2432503-43250398.13498.82
3430326-43032697.64098.34
4417499-41749994.73095.47
5428674-42867497.26598.03
6429102-42910297.36398.05
60min1425422-42542296.52896.711.2297.4497.591.20
2431420-43142097.88898.74
3428711-42871197.27498.14
4416391-41639194.47895.37
5427389-42738996.97497.90
6427909-42790997.09297.94
极限1426340-42634096.73696.751.1997.8197.801.17
2433650-43365098.39499.41
3425999-42599996.65897.69
4418011-41801194.84695.90
5428372-42837297.19798.29
6426088-42608896.67997.69
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