培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
110.764157541531416044160441571415770.08
210.834184341667417550.30
单位质量响应值RSD%判断
3864.033855.490.16数据可信
供试品溶液-719406批-培哚普利-pH2.0盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143801-4380196.82293.094.2096.8293.094.20
241423-4142391.56691.57
344731-4473198.87898.88
441659-4165992.08792.09
540192-4019288.84488.84
640876-4087690.35690.36
10min145352-45352100.25197.273.79101.3398.303.80
243410-4341095.95896.98
346551-46551102.901104.00
443569-4356996.30997.33
541897-4189792.61393.60
643232-4323295.56496.57
15min144737-4473798.89197.781.96101.0899.901.99
243786-4378696.78998.87
345381-45381100.315102.56
444568-4456898.518100.61
542888-4288894.80496.82
644058-4405897.39099.46
20min144938-4493899.33597.412.16102.62100.612.19
243501-4350196.15999.32
345240-45240100.003103.36
444484-4448498.332101.52
542950-4295094.94198.01
643276-4327695.66298.81
30min144145-4414597.58395.412.42101.9799.692.43
242388-4238893.69997.93
344099-4409997.481101.95
443704-4370496.608100.89
541517-4151791.77395.90
643115-4311595.30699.52
45min143694-4369496.58695.171.86102.06100.511.88
242329-4232993.56898.84
343665-4366596.522102.07
443859-4385996.950102.30
541987-4198792.81297.96
642775-4277594.55499.82
极限143488-4348896.13095.721.44102.68102.131.49
242534-4253494.021100.33
343917-4391797.079103.70
443966-4396697.187103.62
542598-4259894.163100.34
643323-4332395.766102.09
培哚普利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2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.981589841587201586911588181586551587740.09
213.981589351587981588660.07
单位质量响应值RSD%判断
11357.2211363.810.05数据可信
供试品溶液-719406批-氨氯地平-pH2.0盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1160925-16092591.82785.394.6991.8385.394.69
2144074-14407482.21182.21
3155596-15559688.78688.79
4144533-14453382.47382.47
5147817-14781784.34784.35
6144939-14493982.70582.70
10min1170227-17022797.13591.904.0198.1592.854.01
2154849-15484988.36089.27
3167796-16779695.74796.73
4155551-15555188.76089.68
5158282-15828290.31991.26
6159629-15962991.08792.01
15min1167806-16780695.75392.132.3697.8594.102.39
2156967-15696789.56891.46
3163433-16343393.25895.31
4158825-15882590.62892.53
5160602-16060291.64293.58
6161121-16112191.93993.87
20min1168735-16873596.28391.802.8699.4594.792.88
2155975-15597589.00291.89
3163339-16333993.20496.29
4157726-15772690.00192.91
5160536-16053691.60594.56
6158942-15894290.69593.65
30min1165127-16512794.22489.942.7398.4693.952.75
2152916-15291687.25791.14
3159539-15953991.03695.16
4155061-15506188.48192.39
5155798-15579888.90192.88
6157223-15722389.71493.67
45min1163935-16393593.54490.202.1398.8295.222.19
2154393-15439388.09992.95
3159729-15972991.14496.28
4156258-15625889.16494.06
5157682-15768289.97694.94
6156465-15646589.28294.24
极限1165314-16531494.33194.141.01100.65100.151.06
2162835-16283592.91798.74
3166680-16668095.111101.26
4163723-16372393.42399.31
5166992-16699295.289101.25
6164317-16431793.76299.71
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
110.764180641622418314173541624417240.24
210.834169041655416720.06
单位质量响应值RSD%判断
3877.703847.830.55数据可信
供试品溶液-719406批-培哚普利-pH2.0盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142715-4271594.35094.005.0594.3594.005.05
242345-4234593.53293.53
342918-4291894.79894.80
444111-4411197.43397.43
538574-3857485.20385.20
644690-4469098.71298.71
10min144552-4455298.40798.102.9099.4699.152.92
244834-4483499.030100.07
344579-4457998.46799.52
444959-4495999.306100.39
541918-4191892.58993.54
645648-45648100.828101.92
15min144341-4434197.94197.982.05100.08100.122.09
244566-4456698.438100.58
344274-4427497.79399.94
444603-4460398.520100.71
542786-4278694.50696.48
645595-45595100.711102.93
20min144007-4400797.20397.802.15100.43101.022.19
244587-4458798.484101.72
344314-4431497.881101.12
444625-4462598.568101.85
542627-4262794.15597.18
645504-45504100.510103.85
30min144169-4416997.56197.331.10101.87101.641.18
244107-4410797.424101.75
344071-4407197.345101.67
444087-4408797.380101.76
543227-4322795.48099.55
644731-4473198.802103.26
45min144017-4401797.22597.621.37102.62103.011.40
244640-4464098.601104.01
344404-4440498.080103.48
443595-4359596.293101.75
543487-4348796.055101.19
645030-4503099.463105.01
极限144140-4414097.49797.911.20103.97104.391.22
244709-4470998.754105.26
344363-4436397.990104.48
443766-4376696.671103.20
543847-4384796.850103.05
645145-4514599.717106.37
培哚普利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2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.981584401589801590101588931589421588530.15
213.981589371587071588220.11
单位质量响应值RSD%判断
11362.8811360.660.02数据可信
供试品溶液-719406批-氨氯地平-pH2.0盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1150618-15061885.93683.534.0885.9483.534.09
2141395-14139580.67480.67
3146897-14689783.81383.81
4149001-14900185.01385.01
5137311-13731178.34378.34
6153169-15316987.39187.39
10min1161041-16104191.88390.332.3792.8491.262.38
2156770-15677089.44690.34
3159508-15950891.00891.94
4159744-15974491.14392.09
5151466-15146686.42087.29
6161425-16142592.10293.07
15min1160828-16082891.76190.432.0793.7492.372.08
2158015-15801590.15692.05
3156686-15668689.39891.34
4158185-15818590.25392.21
5153932-15393287.82789.66
6163358-16335893.20595.20
20min1159398-15939890.94590.432.1193.9493.362.13
2158398-15839890.37593.27
3157999-15799990.14793.08
4159915-15991591.24094.20
5152552-15255287.03989.85
6162659-16265992.80695.84
30min1159528-15952891.01990.011.5495.0393.951.58
2155739-15573988.85892.75
3157442-15744289.82993.77
4158500-15850090.43394.41
5154380-15438088.08291.86
6160917-16091791.81295.87
45min1157250-15725089.72090.321.3794.7495.271.39
2158176-15817690.24895.13
3158516-15851690.44295.38
4157930-15793090.10895.09
5155750-15575088.86493.62
6162224-16222492.55897.64
极限1162913-16291392.95193.690.7998.9699.640.72
2164568-16456893.89599.78
3164452-16445293.82999.77
4162390-16239092.65298.63
5165538-16553894.449100.19
6165398-16539894.369100.48
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
110.764182441616418874169441815417670.27
210.834198342082420320.17
单位质量响应值RSD%判断
3881.693881.070.02数据可信
供试品溶液-687573批-培哚普利-pH2.0盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142219-4221992.80594.962.7192.8194.962.71
244826-4482698.53698.54
344112-4411296.96696.97
443033-4303394.59594.59
543351-4335195.29495.29
641665-4166591.58791.59
10min143309-4330995.20197.521.5896.2398.581.59
244866-4486698.62499.72
344760-4476098.39199.47
444178-4417897.11198.16
545182-4518299.318100.38
643896-4389696.49297.51
15min143610-4361095.86397.391.1297.9599.531.13
244737-4473798.340100.53
344392-4439297.58299.75
444305-4430597.39199.52
544902-4490298.703100.87
643879-4387996.45498.54
20min143444-4344495.49896.710.8598.6599.930.86
244324-4432497.432100.72
344024-4402496.773100.03
443683-4368396.02399.24
544409-4440997.619100.88
644090-4409096.918100.08
30min143122-4312294.79096.481.3099.01100.781.27
244191-4419197.140101.51
344538-4453897.903102.23
443985-4398596.687100.97
543264-4326495.10299.45
644236-4423697.239101.48
45min144189-4418997.13696.421.37102.40101.791.30
243896-4389696.492101.94
344575-4457597.984103.40
442859-4285994.21299.57
543531-4353195.689101.09
644128-4412897.002102.32
极限142875-4287594.24795.370.83100.59101.810.83
243293-4329395.166101.68
343795-4379596.270102.78
443370-4337095.335101.74
543797-4379796.274102.74
643188-4318894.935101.33
培哚普利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2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.981587971587501588151587191591131588390.10
213.981589481596231592860.30
单位质量响应值RSD%判断
11361.8711393.850.20数据可信
供试品溶液-687573批-氨氯地平-pH2.0盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1154234-15423487.87588.532.5487.8788.532.54
2158709-15870990.42490.42
3160810-16081091.62191.62
4152931-15293187.13287.13
5155698-15569888.70988.71
6149947-14994785.43285.43
10min1158911-15891190.53991.491.2591.5292.471.25
2160146-16014691.24392.25
3162846-16284692.78193.80
4158467-15846790.28691.25
5163197-16319792.98193.97
6159885-15988591.09492.04
15min1160315-16031591.33991.271.2893.3293.271.27
2159746-15974691.01593.03
3160614-16061491.51093.56
4157778-15777889.89491.87
5163801-16380193.32595.34
6158927-15892790.54892.51
20min1160133-16013391.23690.741.0794.2393.761.05
2158867-15886790.51493.54
3158301-15830190.19293.26
4156922-15692289.40692.38
5161913-16191392.25095.31
6159458-15945890.85193.82
30min1158610-15861090.36890.200.5294.3894.220.52
2158290-15829090.18694.22
3159671-15967190.97295.04
4157321-15732189.63393.60
5157697-15769789.84893.93
6158305-15830590.19494.17
45min1158666-15866690.40090.201.4695.4195.221.43
2158300-15830090.19195.23
3160576-16057691.48896.57
4153921-15392187.69692.66
5159717-15971790.99996.08
6158700-15870090.41995.40
极限1160418-16041891.39891.360.6597.4297.390.64
2158520-15852090.31796.36
3160938-16093891.69497.79
4160209-16020991.27997.21
5161647-16164792.09898.19
6160375-16037591.37397.36
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