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%
111.484894704882934883894886184886714886880.10
211.384888054886104887080.03
单位质量响应值RSD%判断
42568.6442944.460.63数据可信
供试品溶液-2024041021批-瑞舒伐他汀钙-pH7.0磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1370975-37097574.14178.784.0174.1478.784.01
2406876-40687681.31681.32
3401281-40128180.19880.20
4407576-40757681.45681.46
5400694-40069480.08180.08
6377677-37767775.48175.48
10min1453275-45327590.58993.672.0091.0094.112.00
2472149-47214994.36194.81
3481491-48149196.22996.67
4470732-47073294.07894.53
5464518-46451892.83693.28
6470083-47008393.94994.37
15min1479758-47975895.88297.281.0096.8098.241.01
2485678-48567897.06598.04
3494547-49454798.83899.82
4488036-48803697.53798.51
5487695-48769597.46898.43
6484816-48481696.89397.83
20min1485517-48551797.03397.670.8298.4899.170.83
2486472-48647297.22498.74
3496055-49605599.139100.67
4489714-48971497.87299.39
5488745-48874597.67899.18
6485741-48574197.07898.56
30min1485741-48574197.07897.760.9099.0699.800.89
2484068-48406896.74498.80
3494410-49441098.810100.89
4489238-48923897.77799.84
5487193-48719397.36899.41
6494298-49429898.788100.81
45min1484606-48460696.85197.120.9399.3899.710.93
2482282-48228296.38798.98
3494043-49404398.737101.37
4488408-48840897.611100.21
5483511-48351196.63299.22
6482899-48289996.51099.08
60min1481805-48180596.29197.100.8799.36100.230.86
2481635-48163596.25799.39
3492222-49222298.373101.55
4486632-48663297.256100.40
5484029-48402996.73699.86
6488889-48888997.707100.81
极限1480955-48095596.12196.550.8099.72100.210.81
2480012-48001295.93399.60
3489703-48970397.870101.59
4485888-48588897.107100.79
5481101-48110196.15199.81
6480862-48086296.10399.75
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%
111.074389534386994390304393514396634391390.09
211.194386074385414385740.02
单位质量响应值RSD%判断
39669.2939193.390.86数据可信
供试品溶液-2024041021批-依折麦布-pH7.0磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1102889-10288923.48534.0820.5723.4834.0820.58
2143417-14341732.73532.74
3197873-19787345.16545.17
4159335-15933536.36936.37
5141431-14143132.28232.28
6150944-15094434.45334.45
10min1228196-22819652.08669.6413.3652.2269.8313.36
2327233-32723374.69274.87
3321596-32159673.40573.66
4321998-32199873.49773.70
5292214-29221466.69966.88
6339292-33929277.44477.64
15min1364957-36495783.30394.816.1683.7295.396.21
2429389-42938998.00998.61
3429389-42938998.00998.67
4425401-42540197.09997.71
5412854-41285494.23594.79
6430325-43032598.22398.84
20min1419733-41973395.80598.511.6096.6999.611.69
2434206-43420699.109100.25
3437722-43772299.911101.11
4437662-43766299.898101.05
5427892-42789297.66898.74
6432299-43229998.67499.84
30min1432299-43229998.67498.820.86100.09100.470.90
2430385-43038598.23799.93
3434556-43455699.189100.95
4435440-43544099.391101.10
5427309-42730997.53599.15
6437541-43754199.870101.59
45min1432876-43287698.80598.130.98100.77100.330.97
2427886-42788697.66699.90
3433492-43349298.946101.26
4434192-43419299.106101.36
5423760-42376096.72598.88
6427299-42729997.53299.80
60min1430095-43009598.17198.040.86100.68100.780.89
2427030-42703097.471100.25
3432010-43201098.608101.47
4432549-43254998.731101.54
5423287-42328796.61799.31
6432185-43218598.648101.46
极限1429596-42959698.05797.510.91101.11100.800.90
2425604-42560497.145100.47
3429654-42965498.070101.48
4431817-43181798.564101.92
5421129-42112996.12499.36
6425534-42553497.129100.49
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