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101028-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.4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%
111.204737004723684694224718354729644720580.35
211.264708464686604697530.33
单位质量响应值RSD%判断
42148.0441718.740.73数据可信
供试品溶液-6031601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%
5min1414983-41498384.13883.0012.0284.1483.0012.02
2399629-39962981.02581.02
3471024-47102495.50095.50
4421840-42184085.52885.53
5321631-32163165.21165.21
6427259-42725986.62786.63
10min1475905-47590596.49097.242.1596.6397.382.16
2488360-48836099.01599.15
3490997-49099799.55099.71
4465928-46592894.46794.61
5470482-47048295.39095.50
6485879-48587998.51298.66
15min1495163-495163100.394100.570.89100.70100.880.88
2503480-503480102.080102.38
3494347-494347100.229100.55
4490657-49065799.48199.78
5498299-498299101.030101.30
6494357-494357100.231100.54
20min1494762-494762100.313100.751.15100.78101.221.14
2506454-506454102.683103.15
3494403-494403100.240100.73
4490585-49058599.46699.93
5500642-500642101.505101.94
6494625-494625100.285100.76
30min1493939-493939100.146100.571.09100.78101.211.09
2505327-505327102.455103.10
3494338-494338100.227100.89
4489722-48972299.29199.92
5498936-498936101.159101.76
6494015-494015100.161100.80
45min1493408-493408100.038100.421.02100.84101.221.01
2504416-504416102.270103.08
3494026-494026100.164100.99
4489178-48917899.18199.98
5495867-495867100.537101.31
6494725-494725100.305101.12
60min1490880-49088099.52699.930.90100.49100.900.88
2499461-499461101.266102.25
3488070-48807098.95699.95
4489229-48922999.191100.15
5496402-496402100.645101.59
6493252-493252100.007100.98
极限1489391-48939199.22499.621.14100.36100.761.13
2500296-500296101.435102.59
3489229-48922999.191100.35
4484604-48460498.25399.38
5495544-495544100.471101.58
6489089-48908999.163100.31
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101615-202501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2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%
110.594146974142024136224145424147764143680.12
210.564138314101374119840.64
单位质量响应值RSD%判断
39128.2339013.640.21数据可信
供试品溶液-6031601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%
5min191529-9152920.91531.4551.8420.9231.4551.84
2114940-11494026.26526.26
3280646-28064664.13064.13
494516-9451621.59821.60
5122609-12260928.01728.02
6121457-12145727.75427.75
10min1309460-30946070.71475.6612.3270.7575.7112.34
2316749-31674972.38072.42
3402518-40251891.97992.09
4282719-28271964.60464.64
5330150-33015075.44275.49
6344972-34497278.82978.88
15min1413842-41384294.56696.482.1394.7296.662.15
2419965-41996595.96596.13
3427510-42751097.68997.95
4410313-41031393.76093.90
5429067-42906798.04598.22
6432702-43270298.87699.05
20min1431911-43191198.69598.870.5299.0199.210.51
2434295-43429599.24099.56
3430549-43054998.38498.81
4429956-42995698.24898.55
5433786-43378699.12499.46
6435553-43555399.52799.87
30min1431381-43138198.57498.650.5599.0599.150.54
2434256-43425699.23199.72
3429556-42955698.15798.74
4428705-42870597.96298.43
5431938-43193898.70199.20
6434385-43438599.26099.77
45min1429954-42995498.24898.350.7498.8999.020.72
2431114-43111498.51399.17
3427890-42789097.77698.53
4429965-42996598.25098.88
5427268-42726897.63498.30
6436096-43609699.651100.33
60min1429725-42972598.19698.230.7499.0099.060.71
2429798-42979898.21299.03
3424881-42488197.08998.00
4429175-42917598.07098.86
5431054-43105498.49999.33
6434632-43463299.317100.16
极限1428355-42835597.88397.840.7198.8598.830.71
2428951-42895198.01999.00
3426484-42648497.45598.53
4423927-42392796.87197.82
5428172-42817297.84198.83
6433055-43305598.95799.96
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101028-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.4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%
111.204699954676684703004675674697884690640.29
211.264698774705254702010.10
单位质量响应值RSD%判断
41880.7141758.530.21数据可信
供试品溶液-6031701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%
5min1416762-41676284.72690.748.2184.7390.748.21
2469311-46931195.40995.41
3468344-46834495.21395.21
4470448-47044895.64095.64
5468060-46806095.15595.15
6385002-38500278.27078.27
10min1482847-48284798.16198.804.0398.3098.954.04
2496803-496803100.998101.16
3490710-49071099.76099.92
4495654-495654100.765100.92
5501739-501739102.002102.16
6448264-44826491.13091.26
15min1496712-496712100.980100.572.42101.28100.892.43
2497667-497667101.174101.50
3492610-492610100.146100.47
4496790-496790100.996101.32
5510671-510671103.818104.15
6473846-47384696.33196.61
20min1495031-495031100.638100.851.70101.11101.341.71
2496839-496839101.006101.50
3490658-49065899.749100.24
4501975-501975102.050102.55
5507971-507971103.269103.77
6483985-48398598.39298.84
30min1497780-497780101.197100.641.57101.84101.301.58
2493817-493817100.391101.06
3491001-49100199.819100.48
4499794-499794101.606102.27
5505160-505160102.697103.37
6482785-48278598.14898.76
45min1492398-492398100.103100.321.68100.91101.141.69
2493880-493880100.404101.24
3486637-48663798.93299.76
4496667-496667100.971101.81
5507357-507357103.144103.99
6483876-48387698.37099.14
60min1492522-492522100.128100.311.52101.10101.301.53
2495433-495433100.720101.72
3489299-48929999.473100.46
4497670-497670101.175102.18
5503726-503726102.406103.42
6481868-48186897.96298.90
极限1490910-49091099.80099.781.53100.94100.941.54
2491598-49159899.940101.11
3484717-48471798.54199.70
4495064-495064100.645101.82
5501889-501889102.032103.22
6480756-48075697.73698.83
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101615-202501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2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%
110.594115634124714137234127404134554127900.21
210.564102264140534121400.66
单位质量响应值RSD%判断
38979.2339028.410.09数据可信
供试品溶液-6031701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%
5min183372-8337219.08438.3051.1219.0838.3051.12
2250207-25020757.27357.27
3253844-25384458.10558.11
4221044-22104450.59750.60
5133714-13371430.60730.61
661736-6173614.13114.13
10min1311051-31105171.20083.0723.3671.2383.1423.38
2429860-42986098.39598.49
3430644-43064498.57598.67
4424732-42473297.22197.31
5360881-36088182.60682.66
6220297-22029750.42650.45
15min1426258-42625897.57195.807.6997.7296.017.73
2431983-43198398.88199.14
3435317-43531799.64499.91
4429426-42942698.29698.54
5435048-43504899.58399.77
6353218-35321880.85280.96
20min1427548-42754897.86698.201.6498.1898.561.71
2431626-43162698.80099.22
3434099-43409999.36699.79
4432653-43265399.03599.44
5432789-43278999.06699.42
6415407-41540795.08795.33
30min1431295-43129598.72498.810.5099.2099.340.52
2428575-42857598.10198.69
3433367-43336799.19899.79
4432382-43238298.97399.55
5434376-43437699.42999.95
6430035-43003598.43598.84
45min1428056-42805697.98298.420.4098.6299.120.40
2428907-42890798.17798.93
3429670-42967098.35299.11
4430342-43034298.50699.25
5432985-43298599.11199.80
6429970-42997098.42098.99
60min1428773-42877398.14698.430.4598.9599.290.51
2429445-42944598.30099.22
3433057-43305799.127100.05
4430391-43039198.51799.42
5430964-43096498.64899.50
6427552-42755297.86798.60
极限1427330-42733097.81697.830.2598.7898.840.21
2427425-42742597.83898.92
3427414-42741497.83598.92
4426844-42684497.70598.77
5425995-42599597.51198.53
6429229-42922998.25199.14
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