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)5补液体积(ml)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%
111.024775304785904771954764864766364772870.18
210.994739094748524743800.15
单位质量响应值RSD%判断
43310.9843164.700.24数据可信
中间条件6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%
5min1487639-48763996.37190.056.6996.3790.056.69
2468544-46854492.59792.60
3407177-40717780.46980.47
4468883-46888392.66492.66
5429821-42982184.94484.94
6471791-47179193.23993.24
10min1505701-50570199.94097.202.44100.4897.702.45
2485808-48580896.00996.52
3474131-47413193.70194.15
4490930-49093097.02197.54
5504868-50486899.776100.25
6489669-48966996.77297.29
15min1503425-50342599.49197.532.24100.5898.572.24
2484740-48474095.79896.85
3480307-48030794.92295.89
4492818-49281897.39498.45
5509308-509308100.653101.68
6490291-49029196.89597.95
20min1500472-50047298.90797.582.08100.5599.162.07
2482804-48280495.41597.00
3485486-48548695.94597.44
4494207-49420797.66999.26
5510205-510205100.831102.42
6489329-48932996.70598.30
30min1502629-50262999.33397.622.04101.5399.742.03
2484872-48487295.82497.93
3487278-48727896.30098.33
4492093-49209397.25199.39
5509804-509804100.751102.90
6487037-48703796.25298.38
45min1505382-50538299.87797.472.30102.62100.132.29
2481942-48194295.24597.89
3482923-48292395.43998.00
4492288-49228897.29099.97
5508471-508471100.488103.19
6488122-48812296.46699.13
60min1495584-49558497.94197.012.08101.24100.222.07
2480259-48025994.91298.08
3483628-48362895.57898.67
4491562-49156297.146100.36
5508435-508435100.481103.74
6485908-48590896.02999.23
极限1500639-50063998.94096.712.22102.78100.452.21
2476552-47655294.18097.88
3481754-48175495.20898.83
4487483-48748396.340100.10
5504222-50422299.648103.47
6485374-48537495.92399.66
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)5补液体积(ml)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%
110.894307464322194333214286384285954307040.50
210.964265334274584269960.16
单位质量响应值RSD%判断
39550.4138959.491.07数据可信
中间条件6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%
5min1264568-26456860.66155.9829.6360.6655.9829.63
2327500-32750075.09075.09
3198448-19844845.50145.50
4235810-23581054.06754.07
5131521-13152130.15630.16
6307045-30704570.40070.40
10min1426751-42675197.84794.435.4698.1894.745.53
2424525-42452597.33797.75
3401169-40116991.98192.23
4419175-41917596.11096.41
5370745-37074585.00685.17
6428666-42866698.28698.68
15min1431452-43145298.92597.271.6899.8198.101.77
2425962-42596297.66698.62
3420005-42000596.30097.06
4428029-42802998.14098.97
5411963-41196394.45695.10
6427918-42791898.11599.05
20min1427533-42753398.02697.630.8499.4699.000.87
2421694-42169496.68798.19
3422530-42253096.87998.18
4429198-42919898.40899.79
5423902-42390297.19498.36
6429912-42991298.572100.05
30min1431568-43156898.95197.751.00100.9399.671.04
2424540-42454097.34099.38
3419179-41917996.11197.95
4428685-42868598.290100.22
5425905-42590597.65399.36
6428013-42801398.136100.17
45min1434193-43419399.55397.921.18102.08100.381.21
2423934-42393497.20199.78
3419806-41980696.25598.63
4429341-42934198.441100.91
5425677-42567797.60199.85
6429431-42943198.461101.04
60min1424355-42435597.29897.320.78100.38100.330.75
2423925-42392597.199100.32
3418793-41879396.02298.93
4426015-42601597.678100.70
5428910-42891098.342101.13
6424824-42482497.405100.53
极限1428320-42832098.20797.210.94101.82100.760.95
2419598-41959896.20799.87
3418874-41887496.04199.48
4425804-42580497.630101.19
5424109-42410997.241100.58
6427212-42721297.953101.62
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)5补液体积(ml)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%
111.024747864743304755634751114743404748260.12
210.994737504713374725440.37
单位质量响应值RSD%判断
43087.6642997.630.15数据可信
中间条件6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%
5min1335724-33572466.64983.1112.0866.6583.1212.08
2415565-41556582.49982.50
3427889-42788984.94684.95
4482104-48210495.70995.71
5396231-39623178.66178.66
6454456-45445690.22090.22
10min1441539-44153987.65694.444.7988.0394.904.82
2476826-47682694.66195.12
3462719-46271991.86192.33
4504734-504734100.201100.73
5472661-47266193.83494.27
6495808-49580898.42998.93
15min1477156-47715694.72797.312.7395.5898.302.77
2496903-49690398.64799.63
3474580-47458094.21595.20
4503806-503806100.017101.11
5484053-48405396.09697.05
6504648-504648100.184101.23
20min1482233-48223395.73497.332.4397.1298.852.46
2495392-49539298.34799.88
3473451-47345193.99195.50
4503909-503909100.038101.68
5485190-48519096.32297.81
6501351-50135199.530101.13
30min1486537-48653796.58997.342.5298.5099.412.54
2495304-49530498.329100.41
3470491-47049193.40395.43
4503750-503750100.006102.21
5484796-48479696.24398.27
6501081-50108199.476101.63
45min1485360-48536096.35597.851.8598.81100.461.90
2494885-49488598.246100.87
3484562-48456296.19798.74
4502547-50254799.767102.52
5485407-48540796.36598.93
6504456-504456100.146102.86
60min1482696-48269695.82697.142.6598.81100.292.67
2489967-48996797.270100.44
3470561-47056193.41796.50
4503871-503871100.030103.34
5484821-48482196.24899.35
6503836-503836100.023103.29
极限1483471-48347195.98097.222.7399.50100.912.74
2497114-49711498.689102.40
3469581-46958193.22396.82
4502486-50248699.755103.62
5482568-48256895.80199.43
6502932-50293299.844103.67
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)5补液体积(ml)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%
110.894290294288274272364282284277394282120.18
210.964289054261614275330.46
单位质量响应值RSD%判断
39321.5839008.490.57数据可信
中间条件6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%
5min1114251-11425126.25532.1631.2126.2532.1631.21
2119222-11922227.39727.40
3111678-11167825.66425.66
4221456-22145650.89150.89
5114422-11442226.29426.29
6158618-15861836.45036.45
10min1294292-29429267.62878.6112.6867.7778.7912.72
2321458-32145873.87174.02
3330757-33075776.00876.15
4417973-41797396.05096.33
5324120-32412074.48374.63
6363893-36389383.62383.83
15min1415062-41506295.38197.131.8395.9097.751.89
2426469-42646998.00398.57
3423368-42336897.29097.86
4428411-42841198.44999.27
5411694-41169494.60795.17
6431116-43111699.07199.74
20min1426907-42690798.10398.150.6499.1599.310.72
2426235-42623597.94999.06
3427508-42750898.24299.35
4430823-43082399.003100.37
5422687-42268797.13498.22
6428494-42849498.46899.69
30min1427502-42750298.24098.160.4499.8499.860.53
2426083-42608397.91499.57
3425770-42577097.84299.49
4429885-42988598.788100.70
5425107-42510797.69099.31
6428598-42859898.492100.26
45min1425853-42585397.86198.200.60100.00100.440.70
2425030-42503097.67299.87
3425873-42587397.866100.06
4430418-43041898.910101.37
5426024-42602497.901100.07
6430755-43075598.988101.30
60min1424048-42404897.44697.890.72100.13100.680.79
2421550-42155096.87299.61
3424818-42481897.623100.36
4429232-42923298.638101.65
5427059-42705998.138100.85
6429088-42908898.605101.47
极限1424900-42490097.64297.770.37100.87101.100.46
2425312-42531297.737101.01
3425150-42515097.700100.98
4427302-42730298.194101.75
5423029-42302997.212100.47
6426974-42697498.119101.53
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)5补液体积(ml)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%
111.024730914739984768484725354733574739660.36
210.994733114725554729330.12
单位质量响应值RSD%判断
43009.6243033.030.04数据可信
中间条件6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%
5min1382037-38203775.88190.558.8675.8890.558.86
2436342-43634286.66786.67
3470564-47056493.46493.46
4478005-47800594.94294.94
5486148-48614896.55996.56
6482188-48218895.77395.77
10min1450637-45063789.50696.564.8389.9397.074.85
2464301-46430192.22092.70
3491378-49137897.59898.12
4508075-508075100.915101.44
5506041-506041100.511101.05
6496608-49660898.63799.17
15min1478771-47877195.09498.072.7196.0199.112.75
2477397-47739794.82195.82
3493735-49373598.06699.13
4508158-508158100.931102.02
5507229-507229100.747101.84
6497250-49725098.76599.84
20min1484592-48459296.25098.132.4197.7099.712.44
2478088-47808894.95996.48
3491224-49122497.56899.17
4507394-507394100.779102.43
5507126-507126100.726102.38
6495847-49584798.486100.11
30min1485692-48569296.46998.082.2698.45100.212.29
2478183-47818394.97797.03
3490779-49077997.47999.63
4506718-506718100.645102.85
5505211-505211100.346102.56
6496294-49629498.575100.75
45min1483462-48346296.02697.712.4598.54100.382.48
2475710-47571094.48697.06
3490502-49050297.424100.11
4505965-505965100.496103.26
5505562-505562100.415103.19
6490319-49031997.388100.11
60min1483446-48344696.02397.692.2999.07100.902.33
2475986-47598694.54197.64
3489531-48953197.231100.46
4504600-504600100.224103.55
5503600-503600100.026103.36
6493764-49376498.072101.34
极限1485541-48554196.43997.572.43100.02101.332.45
2473044-47304493.95797.58
3488361-48836196.999100.77
4504307-504307100.166104.05
5504082-504082100.122104.01
6492056-49205697.733101.54
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)5补液体积(ml)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%
110.894287974281494275764260214278584276800.25
210.964268044241474254760.45
单位质量响应值RSD%判断
39272.7338820.800.82数据可信
中间条件6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%
5min174997-7499717.28747.4338.0017.2947.4338.00
2153040-15304035.27635.28
3255625-25562558.92258.92
4217399-21739950.11150.11
5249048-24904857.40657.41
6284429-28442965.56165.56
10min1222630-22263051.31685.7222.3451.4185.9822.38
2325399-32539975.00575.20
3402032-40203292.66993.00
4426784-42678498.37498.65
5428258-42825898.71499.03
6426102-42610298.21798.58
15min1363940-36394083.88895.966.5184.2796.706.65
2415068-41506895.67396.29
3419781-41978196.76097.60
4436505-436505100.615101.44
5436608-436608100.638101.51
6425912-42591298.17399.08
20min1419062-41906296.59498.381.8097.4499.651.90
2428093-42809398.67699.82
3418765-41876596.52697.91
4434190-434190100.081101.46
5437026-437026100.735102.16
6423762-42376297.67799.13
30min1427075-42707598.44198.601.4599.82100.421.49
2424591-42459197.86899.56
3420397-42039796.90298.82
4433760-43376099.982101.92
5436528-436528100.620102.61
6424187-42418797.77599.77
45min1426284-42628498.25998.201.38100.19100.571.40
2423096-42309697.52499.76
3420711-42071196.97499.43
4432603-43260399.715102.21
5433470-43347099.915102.46
6420013-42001396.81399.35
60min1427227-42722798.47698.111.43100.95101.021.44
2421745-42174597.21299.99
3417531-41753196.24199.23
4431537-43153799.470102.52
5433195-43319599.852102.95
6422656-42265697.422100.50
极限1426351-42635198.27497.861.49101.30101.321.48
2421454-42145497.145100.46
3415678-41567895.81499.34
4430358-43035899.198102.80
5432321-43232199.650103.31
6421111-42111197.066100.69
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