厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.843233832268323183227532291322980.10
213.953223232223322280.02
单位质量响应值RSD%判断
2333.672310.250.72数据可信
供试品溶液-24032001批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135231-3523195.80193.302.8395.8093.302.83
235160-3516095.60895.61
333793-3379391.89191.89
433096-3309689.99690.00
535124-3512495.51095.51
633453-3345390.96790.97
10min136796-36796100.05799.821.64100.59100.341.64
237199-37199101.153101.68
336858-36858100.226100.74
435702-3570297.08297.58
537337-37337101.528102.06
636359-3635998.86999.37
15min136645-3664599.646100.482.09100.73101.552.08
237349-37349101.561102.65
337465-37465101.876102.94
435880-3588097.56698.61
537957-37957103.214104.31
636408-3640899.002100.06
20min136703-3670399.80499.822.24101.45101.462.23
236911-36911100.370102.03
336740-3674099.905101.54
436214-3621498.474100.06
538078-38078103.543105.21
635614-3561496.84398.45
30min136991-36991100.58799.611.81102.78101.801.80
236114-3611498.202100.42
336734-3673499.888102.08
436341-3634198.820100.95
537707-37707102.534104.78
635905-3590597.63499.78
45min134864-3486494.80395.621.2797.5698.361.27
234969-3496995.08997.85
335568-3556896.71899.46
434814-3481494.66797.34
535876-3587697.555100.37
634902-3490294.90797.59
60min134847-3484794.75795.031.1098.0498.301.12
235046-3504695.29898.59
334994-3499495.15798.44
434696-3469694.34797.55
535610-3561096.832100.19
634485-3448593.77396.99
极限134485-3448593.77395.122.1697.5898.922.13
235549-3554996.666100.48
335159-3515995.60699.41
433892-3389292.16095.89
535995-3599597.879101.77
634808-3480894.65198.38
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.982053094205265020532262051559205062420522310.06
215.102051253205012520506890.04
单位质量响应值RSD%判断
136998.06135807.220.62数据可信
供试品溶液-24032001批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130907-309071.3601.275.321.361.275.28
230472-304721.3401.34
328930-289301.2731.27
427298-272981.2011.20
527468-274681.2081.21
628109-281091.2361.24
10min157505-575052.5302.472.772.542.482.77
257809-578092.5432.55
356601-566012.4902.50
454356-543562.3912.40
554144-541442.3822.39
656032-560322.4652.47
15min174783-747833.2903.271.953.313.291.95
275764-757643.3333.35
375315-753153.3133.33
471938-719383.1643.18
573245-732453.2223.24
674759-747593.2893.31
20min187817-878173.8633.820.813.903.860.78
287513-875133.8503.89
386983-869833.8263.87
485954-859543.7813.82
586894-868943.8223.86
686327-863273.7973.84
30min1105308-1053084.6324.561.094.694.621.11
2102370-1023704.5034.56
3103621-1036214.5584.62
4103674-1036744.5604.62
5102427-1024274.5064.56
6104378-1043784.5914.65
45min1114435-1144355.0345.051.035.125.131.01
2113732-1137325.0035.09
3115255-1152555.0705.16
4114378-1143785.0315.12
5113632-1136324.9985.08
6116784-1167845.1375.22
60min1123605-1236055.4375.430.545.555.540.52
2123775-1237755.4455.56
3122877-1228775.4055.52
4123669-1236695.4405.55
5122442-1224425.3865.50
6124241-1242415.4655.58
极限1127735-1277355.6195.680.945.765.820.95
2129910-1299105.7155.86
3128073-1280735.6345.78
4128785-1287855.6655.81
5128970-1289705.6735.81
6131008-1310085.7635.91
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.843221232168321883216232081321620.16
213.953222532243322340.04
单位质量响应值RSD%判断
2323.842310.680.41数据可信
供试品溶液-24032501批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133941-3394192.47994.853.6492.4894.853.64
235698-3569897.26697.27
335682-3568297.22397.22
436381-3638199.12799.13
533898-3389892.36292.36
633262-3326290.62990.63
10min135684-3568497.22897.712.2997.7498.242.30
236097-3609798.35498.89
335808-3580897.56698.11
437208-37208101.381101.93
535712-3571297.30597.82
634661-3466194.44194.94
15min135791-3579197.52097.022.0998.5798.092.08
235084-3508495.59396.68
336338-3633899.010100.09
436153-3615398.50699.62
535912-3591297.84998.90
634374-3437493.65994.69
20min135290-3529096.15596.772.5297.7598.382.52
235095-3509595.62397.24
336051-3605198.22899.86
436824-36824100.334102.00
535638-3563897.10398.70
634195-3419593.17194.72
30min136288-3628898.87497.012.41101.0099.162.40
234829-3482994.89997.05
336110-3611098.389100.57
436627-3662799.798102.02
535247-3524796.03898.17
634526-3452694.07396.14
45min134516-3451694.04695.191.8696.7297.881.86
234625-3462594.34397.02
335378-3537896.39499.12
435655-3565597.14999.92
535437-3543796.55599.23
634007-3400792.65995.25
60min135016-3501695.40895.932.7798.6199.152.74
235307-3530796.20199.40
336282-3628298.858102.12
435922-3592297.877101.19
535255-3525596.05999.27
633472-3347291.20194.30
极限134919-3491995.14494.742.1498.8898.492.13
234228-3422893.26197.00
335359-3535996.343100.15
435623-3562397.062100.92
534893-3489395.07398.81
633613-3361391.58595.20
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.982053412205224320533102052716204771320518790.12
215.102053438205270720530720.03
单位质量响应值RSD%判断
136974.57135965.030.53数据可信
供试品溶液-24032501批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138512-385121.6931.674.981.691.675.06
238432-384321.6901.69
338919-389191.7111.71
440274-402741.7711.77
534908-349081.5351.53
636656-366561.6121.61
10min164105-641052.8182.753.452.832.763.47
262418-624182.7442.75
363400-634002.7872.80
465532-655322.8812.89
560573-605732.6632.67
659818-598182.6302.64
15min180573-805733.5433.472.783.573.492.74
277164-771643.3933.42
380814-808143.5533.58
480659-806593.5463.57
578479-784793.4503.47
675565-755653.3223.35
20min190924-909243.9983.972.374.044.022.39
288930-889303.9103.95
391851-918514.0384.08
493385-933854.1064.15
589925-899253.9544.00
687364-873643.8413.88
30min1109610-1096104.8194.682.294.894.742.31
2103947-1039474.5704.64
3107185-1071854.7134.78
4108416-1084164.7674.84
5104939-1049394.6144.68
6103891-1038914.5684.63
45min1119221-1192215.2425.221.025.345.321.05
2117673-1176735.1745.26
3118872-1188725.2265.32
4119926-1199265.2735.37
5120088-1200885.2805.37
6117086-1170865.1485.24
60min1129020-1290205.6735.641.605.805.761.65
2128656-1286565.6575.78
3130403-1304035.7335.86
4128692-1286925.6585.78
5128239-1282395.6385.76
6124315-1243155.4665.58
极限1133907-1339075.8875.801.226.045.951.23
2130344-1303445.7315.88
3132050-1320505.8065.96
4133247-1332475.8586.01
5131752-1317525.7935.94
6129727-1297275.7045.85
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.843229332221322023217732230322250.14
213.953216732270322180.23
单位质量响应值RSD%判断
2328.402309.530.58数据可信
供试品溶液-24032502批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134314-3431493.42893.431.4693.4393.431.46
233506-3350691.22891.23
335001-3500195.29895.30
434118-3411892.89492.89
534345-3434593.51293.51
634609-3460994.23194.23
10min135408-3540896.40695.940.5796.9396.460.57
235435-3543596.48096.99
335214-3521495.87896.41
434900-3490095.02395.54
535140-3514095.67796.20
635324-3532496.17796.70
15min135239-3523995.94695.411.5997.0096.471.57
235860-3586097.63798.68
335252-3525295.98197.04
434309-3430993.41494.46
535065-3506595.47296.52
634538-3453894.03795.10
20min135508-3550896.67895.471.3298.2797.051.31
235021-3502195.35396.94
335099-3509995.56597.16
434186-3418693.07994.64
535288-3528896.07997.66
635276-3527696.04797.63
30min135432-3543296.47295.360.9798.6097.470.94
234941-3494195.13597.25
335079-3507995.51097.64
435365-3536596.28998.37
534730-3473094.56096.68
634589-3458994.17696.29
45min135328-3532896.18895.012.2998.8597.652.24
235755-3575597.35199.99
334862-3486294.92097.58
433559-3355991.37293.99
535414-3541496.42399.06
634453-3445393.80696.44
60min135000-3500095.29594.212.1898.4997.382.14
235390-3539096.35799.54
335021-3502195.35398.54
433346-3334690.79293.91
534770-3477094.66997.85
634076-3407692.78095.94
极限134575-3457594.13893.951.8697.8697.641.80
235447-3544796.512100.23
334416-3441693.70597.42
434574-3457494.13597.76
534577-3457794.14497.85
633442-3344291.05394.73
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.982051974205147720520242050482205212620516170.04
215.102050289204994320501160.02
单位质量响应值RSD%判断
136957.08135769.270.62数据可信
供试品溶液-24032502批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138180-381801.6801.616.541.681.616.61
232788-327881.4431.44
337846-378461.6651.67
435599-355991.5661.57
535855-358551.5781.58
639524-395241.7391.74
10min163003-630032.7722.733.622.782.743.66
259194-591942.6052.61
362834-628342.7652.77
460686-606862.6702.68
561095-610952.6882.70
665616-656162.8872.90
15min178599-785993.4583.461.783.483.481.82
277725-777253.4203.44
379541-795413.5003.52
476766-767663.3783.40
577996-779963.4323.46
680704-807043.5513.58
20min191561-915614.0293.992.494.074.042.51
287953-879533.8703.91
391476-914764.0254.07
488628-886283.9003.94
590644-906443.9884.03
694211-942114.1454.19
30min1106927-1069274.7054.681.344.774.741.32
2104403-1044034.5944.66
3106996-1069964.7084.77
4105478-1054784.6414.71
5105711-1057114.6514.72
6108457-1084574.7724.84
45min1120990-1209905.3245.321.535.425.411.57
2120893-1208935.3195.41
3121306-1213065.3385.43
4117381-1173815.1655.25
5122177-1221775.3765.47
6122596-1225965.3945.49
60min1129250-1292505.6875.671.495.815.791.49
2127876-1278765.6275.74
3130711-1307115.7515.87
4125502-1255025.5225.64
5129271-1292715.6885.81
6130381-1303815.7375.86
极限1132982-1329825.8515.890.796.006.040.70
2134853-1348535.9346.08
3133727-1337275.8846.04
4135566-1355665.9656.11
5133641-1336415.8806.03
6132967-1329675.8516.01
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