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 4133641415416764137041691414980.42
214.044156241423414920.24
单位质量响应值RSD%判断
2962.032955.270.17数据可信
供试品溶液-8153342批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min138188-3818883.67181.893.5683.6781.893.56
236378-3637879.70679.71
336788-3678880.60480.60
437844-3784482.91882.92
535709-3570978.24078.24
639334-3933486.18286.18
10min142195-4219592.45192.832.7093.3893.742.70
241777-4177791.53592.42
341558-4155891.05591.95
444018-4401896.44597.37
541156-4115690.17491.04
643506-4350695.32396.28
15min143088-4308894.40893.842.5696.3695.782.56
242413-4241392.92994.83
342232-4223292.53294.44
444391-4439197.26299.26
541281-4128190.44892.32
643567-4356795.45797.47
20min143461-4346195.22594.532.4998.2397.522.49
242892-4289293.97896.91
342296-4229692.67295.61
444650-4465097.830100.90
541706-4170691.38094.26
643870-4387096.12199.20
30min144985-4498598.56498.332.38102.63102.372.37
244042-4404296.498100.48
345159-4515998.945102.91
446528-46528101.945106.11
543431-4343195.15999.05
645137-4513798.897103.04
45min144621-4462197.76697.672.11102.93102.802.11
244271-4427197.000102.05
344599-4459997.718102.78
446253-46253101.342106.64
543366-4336695.01799.97
644363-4436397.201102.45
极限144146-4414696.72697.492.52102.97103.702.50
243801-4380195.970102.10
344681-4468197.898104.05
446363-46363101.583108.00
543093-4309394.419100.42
644889-4488998.354104.68
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 4154041575416494162041702416170.16
214.044173841797417680.10
单位质量响应值RSD%判断
2970.522974.930.11数据可信
供试品溶液-8153342批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min139302-3930285.70483.944.1785.7083.944.17
239071-3907185.20185.20
340559-4055988.44688.45
438166-3816683.22783.23
538061-3806182.99883.00
635794-3579478.05578.05
10min143826-4382695.57094.962.1796.5295.902.19
243433-4343394.71395.66
345219-4521998.60799.59
443480-4348094.81595.74
542558-4255892.80593.73
642776-4277693.28094.15
15min143491-4349194.83995.912.4896.8597.892.48
244055-4405596.06998.07
345850-4585099.983102.06
444442-4444296.91398.89
543264-4326494.34496.30
642778-4277893.28495.19
20min144355-4435596.72396.422.3899.7999.472.38
243585-4358595.04498.11
346081-46081100.487103.68
444402-4440296.82699.88
543863-4386395.65098.65
643008-4300893.78696.73
30min144304-4430496.61296.872.85100.75101.002.82
242916-4291693.58597.71
346449-46449101.290105.60
445130-4513098.413102.54
544374-4437496.765100.83
643372-4337294.58098.56
45min142524-4252492.73194.542.4597.9599.742.42
242503-4250392.68597.85
345005-4500598.141103.57
444346-4434696.704101.93
542921-4292193.59698.74
642814-4281493.36398.40
极限142707-4270793.13094.402.0499.38100.652.02
242230-4223092.08998.28
344708-4470897.493104.01
443774-4377495.456101.76
542907-4290793.56699.75
643404-4340494.650100.72
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 4181741812417714177041827417990.07
214.044194142033419870.16
单位质量响应值RSD%判断
2983.512990.530.17数据可信
供试品溶液-8153342批-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%
5min121411-2141146.46744.544.7146.4744.544.71
219779-1977942.92542.92
319112-1911241.47741.48
420771-2077145.07845.08
521641-2164146.96646.97
620433-2043344.34444.34
10min129945-2994564.98860.936.2565.5061.436.23
227660-2766060.02960.51
325102-2510254.47754.94
427613-2761359.92760.43
529640-2964064.32664.85
628500-2850061.85262.34
15min129010-2901062.95865.575.0964.2066.745.06
230718-3071866.66567.81
327833-2783360.40461.47
430317-3031765.79566.96
531698-3169868.79270.03
631708-3170868.81469.99
20min134410-3441074.67870.715.1676.6272.615.13
232515-3251570.56572.45
329675-2967564.40266.14
431862-3186269.14871.05
533378-3337872.43874.44
633649-3364973.02674.97
30min135292-3529276.59275.384.0779.3678.074.09
234903-3490375.74878.42
331983-3198369.41071.86
434801-3480175.52678.19
535460-3546076.95679.76
635970-3597078.06380.82
45min137623-3762381.65179.722.8685.2783.242.92
236926-3692680.13883.65
334846-3484675.62478.85
436258-3625878.68882.19
537182-3718280.69484.35
637556-3755681.50585.13
极限142124-4212491.41993.862.2795.9498.272.12
244704-4470497.018101.42
343545-4354594.50398.57
442690-4269092.64797.03
542509-4250992.25496.81
643928-4392895.33499.86
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 4162541571416544162141454415850.20
214.044125641282412690.05
单位质量响应值RSD%判断
2968.242939.390.70数据可信
供试品溶液-8153342批-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%
5min116756-1675636.77438.4010.5936.7738.4010.59
218803-1880341.26741.27
318634-1863440.89640.90
419016-1901641.73441.73
517643-1764338.72138.72
614139-1413931.03131.03
10min125505-2550555.97558.368.1256.3858.788.13
227594-2759460.56061.02
328356-2835662.23262.69
427485-2748560.32160.78
527936-2793661.31161.74
622671-2267149.75650.10
15min129246-2924664.18665.217.3965.2266.297.42
230493-3049366.92268.05
331345-3134568.79269.94
430718-3071867.41668.55
531003-3100368.04269.15
625478-2547855.91656.81
20min131280-3128068.65069.756.1170.3971.546.15
231634-3163469.42671.30
333249-3324972.97174.88
433002-3300272.42974.31
533287-3328773.05474.92
628229-2822961.95463.47
30min133230-3323072.92973.884.2875.4476.464.38
233651-3365173.85376.50
334631-3463176.00478.72
434109-3410974.85877.55
535255-3525577.37380.05
631115-3111568.28770.49
45min136768-3676880.69478.455.6384.0181.845.64
235326-3532677.52981.00
337419-3741982.12385.69
436337-3633779.74883.27
536724-3672480.59784.14
631891-3189169.99072.96
极限144981-4498198.71995.632.90102.9399.892.79
242760-4276093.84498.17
342738-4273893.79698.27
442375-4237592.99997.41
545325-4532599.474103.91
643255-4325594.93198.67
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