培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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8000
标示量(mg)5供试品稀释倍数4系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.01 4114241169412044118241116411630.09
214.044144741362414040.15
单位质量响应值RSD%判断
2938.122949.000.27数据可信
供试品溶液-8153342批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min114580-1458032.10934.617.8732.1134.617.87
213767-1376730.31930.32
316329-1632935.96135.96
416414-1641436.14836.15
516831-1683137.06737.07
616379-1637936.07136.07
10min129136-2913664.16664.633.3064.5265.013.32
227725-2772561.05861.40
329309-2930964.54764.95
430160-3016066.42166.82
530503-3050367.17667.59
629235-2923564.38464.78
15min133141-3314172.98672.982.6974.0674.082.72
231467-3146769.29970.31
333087-3308772.86773.98
433378-3337873.50874.65
534013-3401374.90676.06
633731-3373174.28575.40
20min135087-3508777.27177.063.1779.1578.983.18
233248-3324873.22175.01
334308-3430875.55677.48
435805-3580578.85380.81
536386-3638680.13282.12
635125-3512577.35579.30
30min137909-3790983.48682.551.5386.2385.321.56
236805-3680581.05583.65
337370-3737082.29985.06
437547-3754782.68985.52
538321-3832184.39387.27
636963-3696381.40384.20
45min140663-4066389.55186.882.5193.2290.562.48
238388-3838884.54188.04
338963-3896385.80789.49
439315-3931586.58390.33
540660-4066089.54593.36
638699-3869985.22688.93
极限143105-4310594.92995.671.3499.59100.321.29
243805-4380596.471100.91
343657-4365796.145100.78
443784-4378496.425101.14
543896-4389696.671101.48
642409-4240993.39698.05
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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8000
标示量(mg)5供试品稀释倍数4系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.01 4137441438414264145741505414400.12
214.044110641168411370.11
单位质量响应值RSD%判断
2957.892929.990.68数据可信
供试品溶液-8153342批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min121909-2190948.24449.222.7448.2449.222.74
222032-2203248.51548.52
323293-2329351.29251.29
422169-2216948.81748.82
521783-2178347.96747.97
622926-2292650.48450.48
10min132722-3272272.05571.781.4072.5972.321.40
232646-3264671.88872.43
332875-3287572.39272.96
432258-3225871.03371.58
531899-3189970.24370.78
633175-3317573.05373.61
15min136095-3609579.48379.231.2080.8280.581.21
236084-3608479.45880.80
336233-3623379.78681.16
436040-3604079.36180.69
535127-3512777.35178.66
636308-3630879.95281.32
20min136896-3689681.24682.531.9883.4784.761.96
238051-3805183.79086.01
337915-3791583.49085.75
437397-3739782.35084.56
536360-3636080.06682.24
638266-3826684.26386.52
30min138778-3877885.39186.951.5688.5190.091.51
240338-4033888.82691.98
339470-3947086.91490.10
438790-3879085.41788.55
539809-3980987.66190.72
639737-3973787.50290.70
45min140109-4010988.32189.241.4792.3993.351.44
241582-4158291.56595.70
340678-4067889.57493.73
440465-4046589.10593.18
539871-3987187.79791.83
640452-4045289.07793.25
极限142536-4253693.66696.082.4198.72101.182.32
244999-4499999.089104.25
344768-4476898.581103.73
442835-4283594.32499.39
543742-4374296.321101.33
642920-4292094.51199.67
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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8000
标示量(mg)5供试品稀释倍数4系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.01 4132041253412254124341089412260.21
214.044176941194414820.99
单位质量响应值RSD%判断
2942.612954.560.29数据可信
供试品溶液-8153342批-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%
5min132536-3253671.53173.902.1171.5373.902.11
233989-3398974.72674.73
334064-3406474.89174.89
433035-3303572.62872.63
533630-3363073.93673.94
634427-3442775.68975.69
10min138695-3869585.07288.772.5385.8789.592.53
240310-4031088.62389.45
341070-4107090.29391.13
439976-3997687.88888.70
540526-4052689.09789.92
641687-4168791.65092.49
15min142030-4203092.40493.072.2194.1494.882.19
242096-4209692.54994.36
343402-4340295.42097.26
442018-4201892.37894.16
541012-4101290.16691.98
643439-4343995.50297.36
20min142685-4268593.84495.481.5396.6198.321.51
243725-4372596.13098.97
344289-4428997.370100.27
442961-4296194.45197.26
544000-4400096.73599.55
642913-4291394.34597.27
30min143276-4327695.14397.181.4198.95101.081.39
244822-4482298.542102.45
344327-4432797.454101.43
443722-4372296.12499.98
544869-4486998.646102.53
644190-4419097.153101.12
45min143732-4373296.14697.560.98101.01102.540.99
244428-4442897.676102.68
344907-4490798.729103.79
444187-4418797.146102.07
544789-4478998.470103.45
644206-4420697.188102.24
极限144409-4440997.63497.961.38103.57104.031.32
244510-4451097.856103.95
345344-4534499.690105.85
444379-4437997.568103.58
545099-4509999.151105.23
643608-4360895.873102.00
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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8000
标示量(mg)5供试品稀释倍数4系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.01 4121941298412644121541071412130.22
214.044100240946409740.10
单位质量响应值RSD%判断
2941.682918.380.57数据可信
供试品溶液-8153342批-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%
5min133739-3373974.64779.173.7574.6579.173.75
234592-3459276.53476.53
336113-3611379.89979.90
437212-3721282.33182.33
536803-3680381.42681.43
636230-3623080.15880.16
10min138153-3815384.41287.013.7885.2487.893.77
237133-3713382.15683.01
339491-3949187.37388.26
441316-4131691.41192.33
539738-3973887.91988.82
640138-4013888.80489.69
15min139660-3966087.74790.352.3389.5192.202.35
239762-3976287.97289.74
341018-4101890.75192.61
441988-4198892.89794.83
541592-4159292.02193.90
641003-4100390.71892.60
20min141003-4100390.71892.972.2693.4695.822.29
240822-4082290.31893.06
341843-4184392.57795.44
443006-4300695.15098.11
542862-4286294.83197.74
642583-4258394.21497.10
30min142146-4214693.24794.261.8497.0098.141.88
241321-4132191.42295.17
342672-4267294.41198.31
443444-4344496.119100.14
543295-4329595.78999.75
642737-4273794.55498.49
45min142941-4294195.00696.362.1099.79101.292.10
242241-4224193.45798.22
344250-4425097.902102.85
443851-4385197.019102.11
544745-4474598.997104.02
643294-4329495.787100.77
极限143224-4322495.63295.531.41101.47101.531.43
242348-4234893.69499.49
343399-4339996.019102.05
443718-4371896.725102.89
543823-4382396.957103.08
642553-4255394.147100.19
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