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%
111.194764334767634737044769694766514761040.29
211.224751784749014750400.05
单位质量响应值RSD%判断
42547.2742338.680.35数据可信
长期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%
5min1439269-43926988.43878.2014.1988.4478.2014.19
2415395-41539583.63183.63
3400610-40061080.65480.65
4324425-32442565.31665.32
5435740-43574087.72787.73
6315005-31500563.42063.42
10min1503861-503861101.44299.203.03101.5999.333.04
2504025-504025101.475101.61
3497056-497056100.072100.21
4463747-46374793.36693.47
5494545-49454599.56699.71
6493219-49321999.29999.41
15min1504553-504553101.581100.951.86101.90101.251.86
2512309-512309103.143103.45
3503195-503195101.308101.61
4484518-48451897.54897.81
5499469-499469100.558100.87
6504515-504515101.574101.84
20min1507310-507310102.136101.041.41102.62101.501.42
2508876-508876102.452102.93
3502818-502818101.232101.70
4489087-48908798.46898.89
5500088-500088100.682101.16
6503063-503063101.281101.72
30min1505847-505847101.842101.191.42102.50101.821.43
2511480-511480102.976103.63
3505459-505459101.764102.40
4490278-49027898.70799.30
5501319-501319100.930101.58
6501277-501277100.922101.53
45min1504566-504566101.584101.031.58102.41101.831.59
2512303-512303103.142103.96
3505810-505810101.834102.64
4488891-48889198.42899.18
5498347-498347100.332101.15
6501014-501014100.869101.65
60min1502864-502864101.241100.701.34102.24101.671.35
2508223-508223102.320103.31
3504475-504475101.566102.54
4489917-48991798.63599.55
5494852-49485299.628100.61
6500679-500679100.801101.75
极限1505043-505043101.680100.831.38102.84101.971.39
2509232-509232102.523103.69
3503736-503736101.417102.56
4489415-48941598.53499.62
5498231-498231100.308101.46
6499263-499263100.516101.63
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%
111.124387934382104365474405624402884388800.38
211.144408924372794390860.59
单位质量响应值RSD%判断
39467.6339415.260.10数据可信
长期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%
5min1220553-22055350.20140.8121.2550.2040.8121.26
2217018-21701849.39749.40
3190915-19091543.45543.46
4149128-14912833.94433.94
5174170-17417039.64439.64
6123999-12399928.22428.22
10min1399781-39978190.99789.933.8391.0890.003.84
2409772-40977293.27193.35
3403322-40332291.80391.87
4369762-36976284.16484.22
5384095-38409587.42687.49
6403789-40378991.90991.96
15min1423823-42382396.46996.111.2396.7096.331.23
2426963-42696397.18497.42
3420910-42091095.80696.03
4414827-41482794.42194.62
5418604-41860495.28195.49
6428439-42843997.52097.72
20min1421973-42197396.04896.390.4996.4496.760.50
2425733-42573396.90497.30
3424260-42426096.56896.95
4420224-42022495.65096.00
5423396-42339696.37296.74
6425156-42515696.77297.14
30min1421759-42175995.99997.181.3396.5697.721.31
2424831-42483196.69897.26
3425738-42573896.90597.45
4424872-42487296.70897.22
5438021-43802199.701100.23
6426581-42658197.09797.62
45min1420061-42006195.61396.350.5696.3397.050.56
2426988-42698897.18997.91
3421924-42192496.03796.74
4422789-42278996.23496.91
5423495-42349596.39497.09
6424446-42444696.61197.30
60min1419498-41949895.48496.340.6796.3697.200.66
2427188-42718897.23598.12
3422358-42235896.13597.00
4423804-42380496.46597.30
5421274-42127495.88996.75
6425387-42538796.82597.67
极限1422071-42207196.07096.180.3597.1097.200.36
2424470-42447096.61697.66
3423743-42374396.45197.48
4423150-42315096.31697.31
5420688-42068895.75596.77
6421295-42129595.89396.90
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%
111.194766294750224751974720094749174747550.36
211.224713924715934714920.04
单位质量响应值RSD%判断
42426.7242022.460.68数据可信
长期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%
5min1464667-46466794.03672.3322.3694.0472.3322.36
2300341-30034160.78160.78
3450468-45046891.16391.16
4333522-33352267.49667.50
5318058-31805864.36764.37
6277449-27744956.14856.15
10min1487725-48772598.70397.323.2198.8697.443.21
2490396-49039699.24399.34
3491706-49170699.50899.66
4477992-47799296.73396.85
5451031-45103191.27791.38
6486577-48657798.47098.56
15min1489676-48967699.09899.872.2399.42100.152.21
2500979-500979101.385101.65
3492805-49280599.731100.05
4489918-48991899.14799.42
5477732-47773296.68096.94
6509881-509881103.187103.44
20min1489282-48928299.018100.071.7299.50100.521.70
2504583-504583102.114102.55
3493805-49380599.933100.42
4492564-49256499.682100.12
5482749-48274997.69698.12
6503823-503823101.961102.39
30min1494623-494623100.099100.571.09100.75101.181.08
2503038-503038101.802102.41
3494566-494566100.087100.74
4492544-49254499.678100.28
5492404-49240499.650100.23
6504464-504464102.090102.69
45min1486653-48665398.486100.021.3099.30100.811.27
2500758-500758101.340102.12
3490217-49021799.207100.02
4494765-494765100.128100.90
5490397-49039799.24499.99
6502752-502752101.744102.51
60min1503046-503046101.803100.531.19102.79101.481.19
2500149-500149101.217102.16
3491729-49172999.513100.50
4491763-49176399.520100.46
5490923-49092399.350100.26
6502974-502974101.789102.73
极限1488553-48855398.87099.491.29100.02100.611.27
2499479-499479101.082102.19
3488613-48861398.883100.03
4486414-48641498.43899.54
5486793-48679398.51499.59
6499900-499900101.167102.28
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%
111.124408804372494383854371814383044384000.35
211.144378224350404364310.46
单位质量响应值RSD%判断
39424.4639176.930.45数据可信
长期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%
5min1282345-28234564.49741.1938.4464.5041.1938.44
2120714-12071427.57527.58
3249838-24983857.07157.07
4152459-15245934.82734.83
5159322-15932236.39436.39
6117114-11711426.75326.75
10min1422281-42228196.46390.137.4296.5790.207.44
2355383-35538381.18181.23
3412594-41259494.25094.35
4408924-40892493.41293.47
5408943-40894393.41693.48
6359329-35932982.08382.13
15min1429793-42979398.17997.031.0298.4597.241.04
2419969-41996995.93596.12
3424799-42479997.03897.29
4419360-41936095.79696.01
5428650-42865097.91898.13
6425878-42587897.28597.47
20min1425947-42594797.30097.390.9097.7397.780.88
2425892-42589297.28897.63
3424653-42465397.00597.42
4420722-42072296.10796.48
5429134-42913498.02998.41
6431810-43181098.64098.98
30min1432320-43232098.75697.691.4099.3598.231.40
2426471-42647197.42097.92
3424271-42427196.91897.49
4417996-41799695.48496.02
5430692-43069298.38498.93
6434092-43409299.16199.67
45min1426504-42650497.42897.381.2998.1998.091.27
2423770-42377096.80397.47
3420953-42095396.16096.90
4421801-42180196.35397.05
5429209-42920998.04698.75
6435589-43558999.503100.18
60min1436253-43625399.65597.731.76100.5898.601.75
2424241-42424196.91197.74
3422564-42256496.52897.43
4418341-41834195.56396.42
5428831-42883197.95998.83
6436775-43677599.774100.61
极限1425455-42545597.18896.841.6998.2897.871.67
2423500-42350096.74297.73
3419550-41955095.83996.90
4414305-41430594.64195.65
5424949-42494997.07398.11
6435717-43571799.532100.54
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%
111.194754104752204720394724884717454733800.38
211.224750784731234741000.30
单位质量响应值RSD%判断
42303.8442254.900.09数据可信
长期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%
5min1477638-47763896.53483.9714.9296.5383.9714.92
2358537-35853772.46372.46
3388318-38831878.48278.48
4454853-45485391.92991.93
5337293-33729368.16968.17
6476187-47618796.24196.24
10min1498839-498839100.819100.071.20100.98100.211.21
2499541-499541100.961101.08
3487844-48784498.59798.73
4496672-496672100.381100.53
5487473-48747398.52298.64
6500306-500306101.115101.28
15min1497411-497411100.530100.501.08100.86100.811.10
2500111-500111101.076101.37
3491244-49124499.28499.58
4503576-503576101.776102.10
5490457-49045799.12599.40
6500897-500897101.235101.56
20min1495906-495906100.226100.200.94100.72100.680.95
2502652-502652101.590102.05
3490519-49051999.13799.60
4498545-498545100.760101.25
5490780-49078099.19099.63
6496372-496372100.320100.82
30min1497445-497445100.537100.300.95101.20100.940.96
2501807-501807101.419102.05
3491618-49161899.36099.99
4499958-499958101.045101.70
5489736-48973698.97999.59
6496943-496943100.436101.10
45min1488973-48897398.82599.860.9699.66100.670.96
2499202-499202100.892101.69
3488886-48888698.80799.60
4498111-498111100.672101.50
5491924-49192499.421100.19
6497564-497564100.561101.39
60min1490770-49077099.188100.151.09100.18101.131.09
2501144-501144101.285102.25
3491385-49138599.312100.27
4502480-502480101.555102.55
5490665-49066599.167100.11
6496813-496813100.409101.41
极限1493014-49301499.64299.550.78100.80100.690.78
2498937-498937100.839101.97
3487840-48784098.59699.72
4492458-49245899.529100.69
5489641-48964198.960100.06
6493362-49336299.712100.88
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%
111.124369604358644388404354414381974370600.34
211.144401754380054390900.35
单位质量响应值RSD%判断
39303.9639415.620.21数据可信
长期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%
5min1237725-23772554.22243.8031.4654.2243.8031.46
2114293-11429326.06926.07
3204458-20445846.63546.63
4207394-20739447.30447.30
5124425-12442528.38028.38
6263813-26381360.17360.17
10min1418383-41838395.42891.393.6995.5291.463.71
2379865-37986586.64386.69
3403267-40326791.98192.06
4407213-40721392.88192.96
5385875-38587588.01488.06
6409380-40938093.37593.48
15min1426782-42678297.34496.151.0097.5996.381.01
2414130-41413094.45894.65
3421615-42161596.16696.40
4420998-42099896.02596.26
5423663-42366396.63396.83
6422181-42218196.29596.55
20min1427175-42717597.43496.390.9497.8596.780.95
2416972-41697295.10795.45
3423218-42321896.53196.92
4420999-42099996.02596.42
5426861-42686197.36297.72
6420466-42046695.90396.32
30min1426558-42655897.29396.830.4997.8797.380.49
2421957-42195796.24496.75
3425772-42577297.11497.67
4424212-42421296.75897.31
5426365-42636597.24997.77
6422230-42223096.30696.88
45min1420405-42040595.89096.290.4496.6397.000.41
2422538-42253896.37697.04
3421199-42119996.07196.78
4422666-42266696.40597.12
5425391-42539197.02797.71
6420855-42085595.99296.73
60min1421900-42190096.23196.410.6797.1397.280.65
2421047-42104796.03696.86
3422515-42251596.37197.25
4426118-42611897.19398.07
5425755-42575597.11097.95
6418879-41887995.54296.44
极限1424412-42441296.80495.770.5897.8696.800.59
2418726-41872695.50796.49
3419672-41967295.72296.76
4417237-41723795.16796.20
5420072-42007295.81496.82
6419219-41921995.61996.68
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