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)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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.934863254862964862074862524861464862450.02
211.014860584858594859580.03
单位质量响应值RSD%判断
44487.1944137.870.56数据可信
供试品溶液-2024031121批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1494894-49489495.63389.078.9995.6389.078.99
2469367-46936790.70090.70
3483271-48327193.38793.39
4423119-42311981.76381.76
5497840-49784096.20296.20
6397159-39715976.74676.75
10min1510764-51076498.69997.321.4098.8697.481.41
2507162-50716298.00398.15
3499846-49984696.59096.75
4492457-49245795.16295.30
5510067-51006798.56598.73
6501615-50161596.93197.06
15min1510948-51094898.73597.741.0599.0698.061.06
2511654-51165498.87199.19
3501453-50145396.90097.22
4499489-49948996.52196.82
5508882-50888298.33698.66
6502451-50245197.09397.38
20min1509427-50942798.44197.750.8998.9398.230.90
2510395-51039598.62899.11
3499680-49968096.55797.04
4503963-50396397.38597.84
5509461-50946198.44898.94
6502265-50226597.05797.51
30min1508443-50844398.25197.600.8898.9098.240.88
2509452-50945298.44699.09
3498058-49805896.24496.88
4506359-50635997.84898.47
5506743-50674397.92298.57
6501522-50152296.91397.53
45min1508625-50862598.28697.750.8199.1098.550.81
2509555-50955598.46699.27
3498641-49864196.35797.16
4507692-50769298.10698.89
5507167-50716798.00498.82
6503526-50352697.30198.08
60min1508485-50848598.25997.530.8599.2498.490.85
2508264-50826498.21699.19
3497380-49738096.11397.07
4505922-50592297.76498.71
5506135-50613597.80598.78
6502028-50202897.01197.95
极限1507790-50779098.12597.390.8899.2798.510.88
2507662-50766298.10099.24
3496503-49650395.94497.06
4504781-50478197.54398.65
5505985-50598597.77698.92
6501053-50105396.82397.92
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)1.5补液体积(ml)1.5
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%
111.044365284362994363614362934363444363650.03
211.034361644362414362020.02
单位质量响应值RSD%判断
39525.8239546.870.04数据可信
供试品溶液-2024031121批-瑞舒伐他汀钙-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1279499-27949963.62556.5531.6663.6256.5531.66
2204811-20481146.62346.62
3282074-28207464.21164.21
4213472-21347248.59448.59
5368517-36851783.88983.89
6142229-14222932.37732.38
10min1423490-42349096.40394.694.4396.5194.784.46
2408775-40877593.05393.13
3424933-42493396.73196.84
4417112-41711294.95195.03
5437681-43768199.63399.77
6383782-38378287.36487.42
15min1439467-439467100.04099.441.49100.3199.701.51
2438211-43821199.75499.99
3443178-443178100.884101.15
4439144-43914499.966100.21
5436720-43672099.41499.72
6424296-42429696.58696.79
20min1439345-439345100.012100.060.57100.45100.480.58
2441224-441224100.440100.84
3442508-442508100.732101.17
4440911-440911100.368100.77
5437365-43736599.561100.03
6435989-43598999.24899.61
30min1438752-43875299.87799.980.56100.48100.570.53
2440771-440771100.337100.90
3441483-441483100.499101.10
4440475-440475100.269100.84
5434731-43473198.96299.60
6439130-43913099.963100.49
45min1439019-43901999.938100.180.61100.70100.930.58
2440872-440872100.360101.09
3441832-441832100.578101.35
4441468-441468100.495101.24
5435126-43512699.05299.85
6442098-442098100.639101.33
60min1438687-43868799.86299.940.57100.80100.860.54
2439464-439464100.039100.94
3440749-440749100.332101.27
4440088-440088100.181101.09
5434273-43427398.85799.82
6440970-440970100.382101.24
极限1438321-43832199.77999.810.51100.88100.900.48
2439067-43906799.949101.02
3440056-440056100.174101.28
4439251-43925199.991101.07
5434114-43411498.82199.95
6439910-439910100.141101.17
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)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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.934865654866524863934862724866654865090.04
211.014857454856374856910.02
单位质量响应值RSD%判断
44511.3444113.620.64数据可信
供试品溶液-2024031121批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1494811-49481195.61784.8314.3195.6284.8314.31
2352315-35231568.08168.08
3492435-49243595.15895.16
4429789-42978983.05283.05
5377314-37731472.91272.91
6487286-48728694.16394.16
10min1507406-50740698.05197.031.3698.2197.171.38
2495265-49526595.70595.82
3510932-51093298.73298.89
4500913-50091396.79696.93
5493604-49360495.38495.51
6504553-50455397.50097.66
15min1507378-50737898.04697.790.8098.3798.090.80
2509484-50948498.45398.73
3510713-51071398.69099.01
4504738-50473897.53597.84
5499747-49974796.57196.85
6504148-50414897.42197.74
20min1504585-50458597.50697.621.0697.9998.091.05
2512806-51280699.09599.53
3509828-50982898.51999.01
4503768-50376897.34897.81
5498208-49820896.27496.72
6501901-50190196.98797.47
30min1504887-50488797.56497.531.1998.2198.161.18
2514171-51417199.35899.96
3508292-50829298.22298.87
4502780-50278097.15797.78
5496952-49695296.03196.63
6501206-50120696.85397.50
45min1504754-50475497.53997.611.2198.3598.401.20
2515256-51525699.568100.34
3508622-50862298.28699.10
4502615-50261597.12597.91
5497804-49780496.19696.96
6501802-50180296.96897.77
60min1504591-50459197.50797.461.1498.4898.421.14
2513779-51377999.283100.22
3507536-50753698.07699.06
4501524-50152496.91497.86
5497466-49746696.13097.05
6501263-50126396.86497.83
极限1502568-50256897.11697.131.2298.2598.251.21
2512866-51286699.106100.21
3505876-50587697.75598.90
4498369-49836996.30597.41
5495739-49573995.79696.88
6500501-50050196.71797.84
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)1.5补液体积(ml)1.5
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%
111.044369244370564367764368884367984368880.03
211.034367764366834367300.02
单位质量响应值RSD%判断
39573.1939594.740.04数据可信
供试品溶液-2024031121批-瑞舒伐他汀钙-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1356586-35658681.07555.2131.6981.0855.2131.69
2176008-17600840.01840.02
3294367-29436766.92966.93
4157043-15704335.70635.71
5204039-20403946.39146.39
6268861-26886161.13061.13
10min1436938-43693899.34494.784.2399.4894.874.25
2423600-42360096.31296.38
3430803-43080397.94998.06
4389296-38929688.51288.57
5404862-40486292.05192.13
6415639-41563994.50294.60
15min1437238-43723899.41399.240.9099.7199.490.92
2438673-43867399.73999.97
3442164-442164100.533100.81
4430945-43094597.98298.19
5433527-43352798.56998.80
6436288-43628899.19799.46
20min1434562-43456298.80499.360.7599.2799.770.74
2439297-43929799.881100.27
3441936-441936100.481100.92
4437874-43787499.55799.93
5433674-43367498.60299.00
6434657-43465798.82699.25
30min1435366-43536698.98799.370.7699.6299.950.75
2439066-43906699.828100.39
3440725-440725100.205100.82
4440023-440023100.046100.58
5432903-43290398.42798.99
6434235-43423598.73099.32
45min1435020-43502098.90899.480.8299.70100.230.80
2439458-43945899.917100.64
3441323-441323100.341101.12
4441275-441275100.330101.03
5433322-43332298.52299.25
6434838-43483898.86799.62
60min1434477-43447798.78599.280.7799.75100.200.76
2438209-43820999.633100.53
3440111-440111100.066101.01
4440396-440396100.131101.00
5432493-43249398.33499.22
6434328-43432898.75199.67
极限1433065-43306598.46499.000.7099.59100.080.69
2437299-43729999.426100.49
3438854-43885499.780100.89
4438067-43806799.601100.64
5431564-43156498.12299.17
6433610-43361098.58899.67
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