氨氯地平阿托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100374-202106 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.219540095375952799505095403953010.16
215.209572995611956700.09
单位质量响应值RSD%判断
6265.686294.080.32数据可信
供试品溶液-24092701批-氨氯地平-磷酸盐缓冲液（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%
5min146896-4689648.40948.015.0548.4148.015.06
248636-4863650.20650.21
343994-4399445.41445.41
10min180093-8009382.67883.521.6982.7683.601.69
282483-8248385.14585.23
380158-8015882.74582.82
15min166081-6608168.21469.983.5768.4370.193.56
270549-7054972.82673.05
366733-6673368.88769.10
20min190006-9000692.91193.520.5893.2493.860.58
290824-9082493.75594.10
390963-9096393.89994.23
30min173581-7358175.95678.403.9576.4478.903.94
279322-7932281.88282.39
374958-7495877.37777.86
45min192949-9294995.94996.781.0696.5697.401.05
293454-9345496.47097.11
394864-9486497.92598.54
极限175186-7518677.61280.964.9478.3981.754.90
282712-8271285.38186.18
377395-7739579.89380.67
氨氯地平阿托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500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.763529313529663526113538783531093530990.14
211.703543213541473542340.04
单位质量响应值RSD%判断
30025.4330276.410.59数据可信
供试品溶液-24092701批-阿托伐他汀钙-磷酸盐缓冲液（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%
5min1224462-22446261.49462.282.5461.4962.272.54
2233939-23393964.09064.09
3223545-22354561.24261.24
10min1129694-12969435.53137.054.8935.6337.154.89
2142548-14254839.05239.16
3133454-13345436.56136.66
15min1279514-27951476.57678.822.6676.7478.982.66
2294636-29463680.71880.89
3288930-28893079.15579.32
20min1211239-21123957.87159.033.4958.1659.333.49
2224155-22415561.40961.72
3211068-21106857.82458.12
30min1296405-29640581.20383.882.8081.5984.282.80
2312343-31234385.56985.98
3309805-30980584.87485.27
45min1252894-25289469.28370.613.2769.8071.143.26
2267455-26745573.27273.82
3252882-25288269.28069.81
极限1300722-30072282.38685.292.9883.0285.942.97
2317809-31780987.06787.74
3315419-31541986.41287.06
氨氯地平阿托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100374-202106 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.219542995579956039555695446955230.09
215.209532095279953000.04
单位质量响应值RSD%判断
6280.286269.740.12数据可信
供试品溶液-24092701批-氨氯地平
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min140896-4089642.24841.768.0942.2541.768.08
243428-4342844.86444.86
336944-3694438.16638.17
10min183858-8385886.63184.412.3286.7084.482.32
280311-8031182.96783.04
380952-8095283.62983.69
15min158932-5893260.88161.395.1561.1061.605.14
262701-6270164.77464.99
356648-5664858.52158.72
20min192035-9203595.07992.952.0195.3993.262.00
289197-8919792.14792.47
388682-8868291.61591.92
30min166869-6686969.08070.285.7369.5670.755.71
272370-7237074.76375.24
364838-6483866.98267.44
45min195429-9542998.58596.761.8599.1797.341.85
293569-9356996.66397.26
391981-9198195.02395.59
极限170974-7097473.32174.234.0574.0874.984.03
275094-7509477.57778.34
369488-6948871.78672.51
氨氯地平阿托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500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.763549733548713548603546303548483548360.04
211.703568983565893567440.07
单位质量响应值RSD%判断
30173.1330490.940.75数据可信
供试品溶液-24092701批-阿托伐他汀钙
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1199339-19933954.28553.998.2754.2953.998.27
2214083-21408358.30158.30
3181353-18135349.38749.39
10min1124093-12409333.79433.621.3833.8833.711.37
2121535-12153533.09733.19
3124755-12475533.97434.06
15min1243539-24353966.32267.675.6866.4767.815.68
2264382-26438271.99872.15
3237520-23752064.68364.82
20min1199875-19987554.43154.141.2154.6954.401.19
2196058-19605853.39253.66
3200456-20045654.59054.84
30min1260465-26046570.93272.534.6771.2872.884.66
2280616-28061676.41976.78
3257942-25794270.24570.58
45min1247954-24795467.52566.571.4867.9967.041.45
2240739-24073965.56066.05
3244672-24467266.63167.09
极限1268427-26842773.10074.783.6773.6875.363.66
2286206-28620677.94278.54
3269143-26914373.29573.86
氨氯地平阿托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100374-202106 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.219512995219952789512895089951690.09
215.209571095689957000.02
单位质量响应值RSD%判断
6257.006296.050.44数据可信
供试品溶液-24092701批-氨氯地平
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min141193-4119342.54538.1911.8942.5538.1911.89
232422-3242233.48633.49
337303-3730338.52838.53
10min136561-3656137.76140.3912.4937.8340.4512.44
244730-4473046.19846.25
336019-3601937.20137.27
15min164704-6470466.82862.456.1766.9662.586.16
257692-5769259.58659.72
359001-5900160.93861.06
20min167657-6765769.87866.809.4170.1267.039.38
268690-6869070.94571.18
357674-5767459.56759.80
30min173365-7336575.77372.244.2476.1472.594.24
268251-6825170.49270.84
368227-6822770.46770.79
45min179484-7948482.09377.619.1682.5878.089.13
278733-7873381.31881.79
367206-6720669.41269.86
极限177400-7740079.94176.414.2280.5777.014.21
271296-7129673.63774.24
373253-7325375.65876.22
氨氯地平阿托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500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.763544293548393548133540403541113544460.11
211.703563663564683564170.03
单位质量响应值RSD%判断
30139.9730462.990.76数据可信
供试品溶液-24092701批-阿托伐他汀钙
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1201925-20192555.04548.8011.6155.0548.8011.62
2161393-16139343.99644.00
3173712-17371247.35447.35
10min1175443-17544347.82651.1611.0747.9251.2411.04
2211662-21166257.69957.77
3175942-17594247.96248.04
15min1273287-27328774.49968.717.4574.6768.887.44
2245136-24513666.82466.99
3237737-23773764.80864.97
20min1277558-27755875.66372.258.2775.9672.538.26
2277796-27779675.72876.01
3239720-23972065.34865.61
30min1296141-29614180.72975.486.2181.1575.886.20
2271275-27127573.95074.36
3263193-26319371.74772.12
45min1304630-30463083.04378.738.1683.6079.268.15
2300054-30005481.79582.33
3261722-26172271.34671.84
极限1305839-30583983.37278.635.5184.0779.295.51
2284791-28479177.63578.30
3274739-27473974.89475.51
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