依折麦布阿托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DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.021759021757071758931758331751421756950.19
210.111762631771211766920.35
单位质量响应值RSD%判断
17534.4317476.950.24数据可信
供试品溶液-X007293批-依折麦布-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min17851-78514.0235.1819.974.025.1820.02
210858-108585.5645.56
37366-73663.7753.77
412192-121926.2476.25
511687-116875.9895.99
610710-107105.4885.49
10min115500-155007.9438.293.107.968.323.18
216401-164018.4048.44
315571-155717.9798.00
416573-165738.4928.53
516608-166088.5108.54
616374-163748.3908.42
15min116636-166368.5258.561.538.598.631.49
216776-167768.5968.67
316977-169778.6998.76
416861-168618.6408.72
516748-167488.5828.66
616241-162418.3228.40
20min116486-164868.4488.522.028.568.641.96
217152-171528.7898.91
316919-169198.6708.78
416543-165438.4778.61
516457-164578.4338.56
616246-162468.3258.45
30min115996-159968.1978.211.548.368.381.47
216014-160148.2068.38
316497-164978.4538.62
415939-159398.1688.34
515829-158298.1118.29
615845-158458.1198.29
45min116360-163608.3838.242.108.598.462.06
216503-165038.4578.68
315940-159408.1688.38
416128-161288.2648.49
516053-160538.2268.45
615546-155467.9668.18
60min115964-159648.1808.101.758.438.361.69
216050-160508.2248.49
315854-158548.1248.38
415687-156878.0388.31
515959-159598.1788.44
615298-152987.8398.10
极限115487-154877.9368.071.588.238.381.56
215772-157728.0828.39
316075-160758.2378.54
415643-156438.0168.33
515994-159948.1968.51
615505-155057.9458.25
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.991547331547711548271545521541891546140.17
211.091551981562421557200.48
单位质量响应值RSD%判断
14068.6114041.480.14数据可信
供试品溶液-X007293批-阿托伐他汀钙-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min172722-7272242.73857.6324.5542.7457.6324.55
292863-9286354.57554.57
372221-7222142.44442.44
4134239-13423978.89178.89
5113059-11305966.44466.44
6103313-10331360.71660.72
10min1155963-15596391.65894.582.4391.9094.902.49
2164393-16439396.61296.92
3156294-15629491.85292.09
4164749-16474996.82197.26
5161641-16164194.99595.36
6162615-16261595.56795.90
15min1165994-16599497.55397.950.7098.3098.800.67
2168649-16864999.11399.95
3167418-16741898.39099.14
4165870-16587097.48098.46
5166489-16648997.84498.74
6165622-16562297.33498.20
20min1165257-16525797.12097.591.5098.4198.981.46
2170608-170608100.265101.66
3167129-16712998.22099.51
4165018-16501896.97998.50
5163835-16383596.28497.72
6164533-16453396.69498.10
30min1162860-16286095.71196.350.8397.5498.290.82
2163762-16376296.24198.19
3165174-16517497.07198.91
4164446-16444696.64398.70
5161990-16199095.20097.18
6165493-16549397.25999.20
45min1166676-16667697.95496.581.18100.3199.051.13
2166166-16616697.654100.14
3163468-16346896.06998.45
4165077-16507797.01499.61
5161828-16182895.10597.61
6162840-16284095.69998.19
60min1161556-16155694.94595.520.8497.8598.530.88
2164321-16432196.57099.59
3161001-16100194.61997.53
4164040-16404096.40599.54
5162357-16235795.41698.45
6161952-16195295.17898.20
极限1161031-16103194.63695.370.8198.0798.900.84
2163675-16367596.19099.75
3161486-16148694.90498.34
4163283-16328395.96099.63
5160790-16079094.49598.06
6163385-16338596.02099.57
依折麦布阿托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DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.021742241744051745121747351750521745860.19
210.111757861763291760580.22
单位质量响应值RSD%判断
17423.7517414.240.04数据可信
供试品溶液-X007293批-依折麦布-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min110847-108475.5865.4213.755.595.4213.74
211683-116836.0166.02
310568-105685.4425.44
47664-76643.9473.95
511119-111195.7265.73
611213-112135.7745.77
10min115574-155748.0208.223.318.058.263.34
216287-162878.3878.42
316182-161828.3338.36
415315-153157.8877.91
516747-167478.6248.66
615720-157208.0958.13
15min115444-154447.9538.292.248.038.372.23
216307-163078.3988.48
316480-164808.4878.56
416044-160448.2628.33
516266-162668.3778.46
616098-160988.2908.37
20min115310-153107.8848.242.298.008.362.30
216222-162228.3548.48
316017-160178.2488.37
416135-161358.3098.42
516356-163568.4238.55
616008-160088.2448.37
30min115384-153847.9228.071.748.098.241.65
215726-157268.0988.27
315375-153757.9188.09
416107-161078.2958.45
515731-157318.1018.27
615729-157298.1008.27
45min115228-152287.8428.051.978.058.261.92
215419-154197.9408.16
315682-156828.0768.29
415859-158598.1678.37
516064-160648.2738.49
615494-154947.9798.19
60min115340-153407.9007.961.738.158.221.72
215521-155217.9938.26
315062-150627.7578.01
415499-154997.9828.23
515883-158838.1798.44
615480-154807.9728.23
极限115112-151127.7827.880.928.088.180.92
215332-153327.8968.20
315338-153387.8998.20
415280-152807.8698.16
515542-155428.0048.31
615262-152627.8608.16
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.991535861534491536341535131540561536480.16
211.091546311556631551470.48
单位质量响应值RSD%判断
13980.7113989.810.05数据可信
供试品溶液-X007293批-阿托伐他汀钙-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1124470-12447073.51561.2521.8573.5161.2621.85
2108320-10832063.97663.98
399958-9995859.03759.04
460988-6098836.02136.02
5109174-10917464.48164.48
6119364-11936470.49970.50
10min1160335-16033594.69795.954.2395.1196.294.27
2167018-16701898.64599.00
3161327-16132795.28395.61
4150676-15067688.99389.19
5170443-170443100.667101.03
6164890-16489097.38897.78
15min1163658-16365896.66098.821.6497.5999.681.67
2169027-16902799.831100.73
3166886-16688698.56799.42
4164691-16469197.27097.96
5170764-170764100.857101.77
6168820-16882099.709100.64
20min1161170-16117095.19198.982.2996.66100.402.27
2169816-169816100.297101.76
3165793-16579397.92199.33
4167792-16779299.102100.34
5172375-172375101.808103.29
6168579-16857999.566101.05
30min1161361-16136195.30397.751.4397.3099.721.43
2166477-16647798.325100.34
3164553-16455397.18999.14
4165487-16548797.74099.53
5167269-16726998.793100.84
6167869-16786999.147101.19
45min1165347-16534797.65898.801.13100.19101.321.15
2167908-16790899.170101.73
3164911-16491197.40099.89
4167182-16718298.741101.07
5169850-169850100.317102.91
6168491-16849199.514102.11
60min1163468-16346896.54897.811.5299.62100.881.54
2166082-16608298.092101.20
3162725-16272596.10999.14
4164572-16457297.200100.08
5169297-16929799.991103.14
6167521-16752198.942102.09
极限1162697-16269796.09297.701.6099.70101.311.60
2166943-16694398.600102.26
3162665-16266596.07499.64
4164930-16493097.411100.83
5169557-169557100.144103.85
6165724-16572497.880101.57
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