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)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%
111.824658854646394642774603024621704634550.48
211.894660284665554662920.08
单位质量响应值RSD%判断
39209.3939217.160.02数据可信
中间条件24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%
5min1449780-44978098.01296.975.1198.0196.975.11
2446095-44609597.20997.21
3468734-468734102.142102.14
4407816-40781688.86788.87
5465847-465847101.513101.51
6431726-43172694.07794.08
10min1470649-470649102.559103.181.64102.72103.341.65
2463082-463082100.910101.07
3478499-478499104.270104.44
4466824-466824101.726101.87
5480248-480248104.651104.82
6481802-481802104.989105.15
15min1475632-475632103.645103.780.94103.98104.120.94
2472848-472848103.038103.37
3480493-480493104.704105.05
4469956-469956102.408102.73
5477005-477005103.944104.29
6481592-481592104.944105.28
20min1479530-479530104.494103.840.92105.00104.350.92
2469735-469735102.360102.86
3480896-480896104.792105.31
4473015-473015103.075103.56
5476748-476748103.888104.40
6479374-479374104.460104.97
30min1478071-478071104.176103.830.54104.86104.510.55
2472643-472643102.994103.67
3477929-477929104.145104.84
4474587-474587103.417104.08
5476023-476023103.730104.42
6479623-479623104.515105.20
45min1479426-479426104.472103.500.81105.33104.350.81
2469189-469189102.241103.09
3476301-476301103.791104.66
4471462-471462102.736103.57
5477027-477027103.949104.81
6476348-476348103.801104.66
60min1473704-473704103.225103.361.06104.25104.391.06
2468967-468967102.193103.21
3480015-480015104.600105.64
4473052-473052103.083104.09
5469598-469598102.330103.37
6480681-480681104.745105.77
极限1473701-473701103.224103.290.97104.43104.480.97
2468807-468807102.158103.34
3476243-476243103.778104.99
4468697-468697102.134103.31
5476214-476214103.772104.98
6480257-480257104.653105.86
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)0
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%
111.124250244245144229994193714212724226360.56
211.224240124264084252100.40
单位质量响应值RSD%判断
38006.8337897.500.21数据可信
中间条件24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%
5min1191527-19152745.30554.5219.0845.3154.5219.08
2222230-22223052.56852.57
3257718-25771860.96360.96
4205138-20513848.52548.53
5306361-30636172.46972.47
6199836-19983647.27147.27
10min1369119-36911987.31492.542.9887.3992.632.99
2388057-38805791.79491.88
3394712-39471293.36893.47
4396161-39616193.71193.79
5400044-40004494.63094.75
6399190-39919094.42894.51
15min1399388-39938894.47595.971.2794.7096.211.28
2402287-40228795.16095.40
3408799-40879996.70196.96
4402341-40234195.17395.41
5408387-40838796.60396.88
6412980-41298097.69097.93
20min1404814-40481495.75896.230.9196.1496.630.91
2402568-40256895.22795.63
3410070-41007097.00197.42
4404843-40484395.76596.16
5406053-40605396.05196.49
6412394-41239497.55197.95
30min1403459-40345995.43896.060.6795.9896.630.67
2405443-40544395.90796.46
3407253-40725396.33596.92
4405445-40544595.90796.46
5404070-40407095.58296.18
6410963-41096397.21397.77
45min1404439-40443995.66996.070.6796.3796.790.67
2405843-40584396.00196.72
3405424-40542495.90296.64
4403255-40325595.38996.10
5406790-40679096.22596.98
6411017-41101797.22597.95
60min1402566-40256695.22695.791.0596.0896.671.04
2401621-40162195.00395.88
3408771-40877196.69497.59
4403667-40366795.48796.36
5401427-40142794.95795.88
6411589-41158997.36198.25
极限1401155-40115594.89395.660.9695.9196.700.96
2402710-40271095.26096.30
3404988-40498895.79996.86
4401045-40104594.86695.90
5405065-40506595.81796.89
6411406-41140697.31798.37
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)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%
111.824676454653304679454672254681634672620.25
211.894636284629454632860.11
单位质量响应值RSD%判断
39531.4738964.341.03数据可信
中间条件24月-供试品溶液-2024040921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%
5min1420902-42090291.64391.775.4991.6491.775.49
2389984-38998484.91184.91
3397707-39770786.59286.59
4446600-44660097.23897.24
5435186-43518694.75394.75
6438655-43865595.50895.51
10min1440617-44061795.93595.974.1096.0996.124.11
2429190-42919093.44793.59
3411283-41128389.54889.69
4460316-460316100.224100.39
5448996-44899697.75997.92
6454162-45416298.88499.04
15min1439568-43956895.70796.493.9996.0296.803.99
2440275-44027595.86196.16
3411835-41183589.66889.96
4461751-461751100.537100.87
5448986-44898697.75798.08
6456471-45647199.38799.71
20min1438739-43873995.52696.003.9296.0096.483.92
2431786-43178694.01294.47
3412089-41208989.72490.17
4458333-45833399.792100.29
5450334-45033498.05198.53
6454259-45425998.90599.39
30min1438088-43808895.38496.143.6396.0296.783.63
2437340-43734095.22295.84
3413647-41364790.06390.66
4458607-45860799.852100.52
5448482-44848297.64898.29
6453142-45314298.66299.32
45min1438817-43881795.54396.074.1096.3396.874.10
2436562-43656295.05295.82
3410467-41046789.37190.11
4464035-464035101.034101.86
5445597-44559797.01997.83
6452059-45205998.42699.25
60min1444380-44438096.75495.463.7897.7096.413.78
2433310-43331094.34495.27
3407209-40720988.66189.55
4446214-44621497.15498.15
5447220-44722097.37398.34
6452315-45231598.48299.47
极限1434864-43486494.68295.454.0195.7996.564.01
2435043-43504394.72195.81
3407153-40715388.64989.69
4455735-45573599.227100.39
5445072-44507296.90598.04
6452439-45243998.50999.66
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)0
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%
111.124273394274044282674277104272964276030.10
211.224254294239494246890.25
单位质量响应值RSD%判断
38453.5137851.071.12数据可信
中间条件24月-供试品溶液-2024040921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%
5min1223025-22302552.48351.9918.2152.4851.9918.21
2148222-14822234.88034.88
3253879-25387959.74359.74
4208748-20874849.12349.12
5258586-25858660.85160.85
6233225-23322554.88354.88
10min1383151-38315190.16488.756.8790.2588.836.87
2326844-32684476.91376.97
3375505-37550588.36488.46
4387983-38798391.30191.38
5399503-39950394.01294.11
6389861-38986191.74391.83
15min1404632-40463295.21995.210.5495.4695.440.55
2403578-40357894.97195.16
3404355-40435595.15395.40
4401991-40199194.59794.83
5408482-40848296.12596.38
6404438-40443895.17395.42
20min1405768-40576895.48695.191.0695.8895.581.07
2400361-40036194.21494.56
3404905-40490595.28395.69
4398966-39896693.88594.28
5410690-41069096.64497.06
6406300-40630095.61196.01
30min1402203-40220394.64795.230.7095.2095.780.70
2405561-40556195.43795.94
3406431-40643195.64296.21
4400573-40057394.26494.81
5408176-40817696.05396.63
6405151-40515195.34195.90
45min1402919-40291994.81695.170.4195.5395.880.42
2403980-40398095.06595.73
3406157-40615795.57896.30
4403196-40319694.88195.59
5406748-40674895.71796.46
6403467-40346794.94595.67
60min1406668-40666895.69894.741.7296.5795.611.72
2401391-40139194.45695.28
3402824-40282494.79395.68
4389638-38963891.69092.55
5409069-40906996.26397.16
6405968-40596895.53396.41
极限1400427-40042794.22994.470.5795.2695.490.58
2401597-40159794.50495.48
3403034-40303494.84395.88
4397662-39766293.57894.59
5404283-40428395.13796.20
6401599-40159994.50595.54
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)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%
111.824664684594544636244618664619614626750.56
211.894625914625824625860.01
单位质量响应值RSD%判断
39143.4038905.470.44数据可信
中间条件24月-供试品溶液-2024041021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%
5min1457815-457815100.24697.167.25100.2597.167.25
2467124-467124102.284102.28
3417276-41727691.36991.37
4391984-39198485.83185.83
5453510-45351099.30399.30
6474503-474503103.900103.90
10min1482341-482341105.616103.005.04105.78103.165.05
2490075-490075107.310107.48
3448672-44867298.24498.40
4435231-43523195.30195.44
5471739-471739103.295103.46
6494259-494259108.226108.40
15min1497353-497353108.904105.253.07109.25105.583.08
2485850-485850106.385106.73
3467074-467074102.274102.59
4464289-464289101.664101.97
5472525-472525103.467103.80
6496790-496790108.780109.13
20min1495270-495270108.447105.492.19108.97106.002.20
2487146-487146106.669107.20
3472903-472903103.550104.04
4470280-470280102.976103.45
5474461-474461103.891104.40
6490563-490563107.417107.95
30min1493006-493006107.952105.512.11108.66106.192.12
2484953-484953106.188106.89
3472607-472607103.485104.14
4468723-468723102.635103.28
5479204-479204104.930105.61
6492536-492536107.849108.56
45min1493716-493716108.107105.172.47108.99106.032.47
2484880-484880106.172107.05
3469562-469562102.818103.65
4470333-470333102.987103.80
5469887-469887102.889103.75
6493527-493527108.066108.96
60min1489252-489252107.130104.492.40108.20105.522.41
2484252-484252106.035107.09
3469337-469337102.769103.77
4464161-464161101.636102.62
5467475-467475102.361103.39
6488625-488625106.992108.07
极限1490931-490931107.497104.322.39108.74105.542.39
2481092-481092105.343106.58
3465121-465121101.846103.02
4467014-467014102.260103.42
5467397-467397102.344103.54
6487089-487089106.656107.91
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)0
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%
111.124292864218084241714231384231164243040.69
211.224240794254094247440.23
单位质量响应值RSD%判断
38156.8337855.970.56数据可信
中间条件24月-供试品溶液-2024041021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%
5min173038-7303817.25337.1156.4717.2537.1156.48
2242448-24244857.27057.27
384451-8445119.94819.95
471892-7189216.98216.98
5225342-22534253.22953.23
6245442-24544257.97757.98
10min1272117-27211764.27878.7028.8564.3178.7628.87
2419497-41949799.09199.19
3242954-24295457.38957.42
4224588-22458853.05153.08
5418478-41847898.85098.94
6421369-42136999.53399.63
15min1401120-40112094.75094.985.5394.8995.175.59
2418069-41806998.75499.01
3374657-37465788.49988.63
4375808-37580888.77188.89
5418421-41842198.83799.09
6424469-424469100.265100.53
20min1420849-42084999.41098.790.8199.7099.140.86
2418900-41890098.95099.38
3414641-41464197.94498.22
4413415-41341597.65497.92
5420999-42099999.44699.86
6420595-42059599.35099.78
30min1425811-425811100.58299.630.68101.04100.150.64
2417595-41759598.64299.23
3420662-42066299.36699.81
4423043-42304399.929100.36
5423202-42320299.966100.55
6420350-42035099.29399.89
45min1425793-425793100.57899.410.68101.21100.100.64
2419908-41990899.18899.94
3419530-41953099.09999.70
4422607-42260799.826100.42
5417926-41792698.72099.47
6419402-41940299.06999.83
60min1419526-41952699.09898.970.6599.8999.820.58
2415592-41559298.16999.09
3420182-42018299.253100.02
4422708-42270899.850100.61
5416106-41610698.29099.21
6419858-41985899.176100.10
极限1420332-42033299.28898.600.62100.2599.610.57
2414220-41422097.84598.93
3415562-41556298.16299.10
4420634-42063499.360100.29
5416992-41699298.49999.58
6416702-41670298.43199.52
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