富马酸比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048395683896840158401883758839290.13
210.068403884040840390.01
单位质量响应值RSD%判断
8359.468353.780.05数据可信
加速6月-供试品溶液-2024110221批-富马酸比索洛尔-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%
5min188901-8890195.55496.250.8295.5596.250.82
290013-9001396.74996.75
389261-8926195.94195.94
488591-8859195.22195.22
590228-9022896.98096.98
690295-9029597.05297.05
10min190962-9096297.76998.240.7897.9398.400.77
291620-9162098.47798.64
392510-9251099.43399.59
490447-9044797.21697.37
591212-9121298.03898.20
691654-9165498.51398.67
15min191212-9121298.03898.570.7398.3698.890.73
291301-9130198.13498.46
392819-9281999.765100.09
491165-9116597.98798.31
591543-9154398.39498.72
692192-9219299.09199.42
20min191780-9178098.64998.730.6999.1399.220.69
291431-9143198.27398.76
392876-9287699.827100.32
491297-9129798.12998.61
591406-9140698.24798.74
692356-9235699.26899.76
30min191820-9182098.69198.900.6799.3499.550.67
291604-9160498.45999.11
393028-9302899.990100.65
491512-9151298.36099.01
591597-9159798.45299.10
692498-9249899.420100.08
45min191676-9167698.53798.670.5799.3599.480.57
291416-9141698.25799.07
392570-9257099.498100.32
491409-9140998.25099.06
591401-9140198.24199.06
692319-9231999.228100.05
极限191336-9133698.17198.470.5899.1599.450.58
291174-9117497.99798.98
392505-9250599.428100.42
491306-9130698.13999.11
591356-9135698.19399.17
692000-9200098.88599.87
富马酸比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.064872648657492924866648543487770.61
214.064853648482485090.08
单位质量响应值RSD%判断
3469.203450.140.39数据可信
加速6月-供试品溶液-2024110221批-左氨氯地平-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%
5min136705-3670566.98666.704.3466.9966.704.34
235297-3529764.41664.42
334663-3466363.25963.26
438708-3870870.64170.64
535859-3585965.44265.44
638058-3805869.45569.46
10min145029-4502982.17782.942.5482.2983.062.54
243966-4396680.23780.34
344916-4491681.97182.08
447318-4731886.35586.47
545327-4532782.72182.83
646141-4614184.20784.32
15min147284-4728486.29387.892.0986.5488.142.09
248256-4825688.06688.31
348668-4866888.81889.06
449878-4987891.02791.29
547354-4735486.42086.67
647512-4751286.70986.96
20min147872-4787287.36689.702.8187.7690.102.80
250303-5030391.80292.19
348025-4802587.64588.03
450519-5051992.19692.61
547797-4779787.22987.62
650396-5039691.97292.37
30min148512-4851288.53491.913.0789.0792.463.07
251078-5107893.21693.76
348986-4898689.39989.93
452593-5259395.98196.55
549772-4977290.83391.37
651234-5123493.50194.06
45min148347-4834788.23292.372.9888.9293.072.97
251607-5160794.18294.88
350045-5004591.33192.02
452659-5265996.10296.83
549924-4992491.11091.80
651097-5109793.25193.96
极限149497-4949790.33193.051.8991.1693.901.90
251953-5195394.81395.67
350982-5098293.04193.88
452047-5204794.98595.87
550389-5038991.95992.80
651051-5105193.16794.03
富马酸比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048396884025840328399484267840570.15
210.068390083952839260.05
单位质量响应值RSD%判断
8372.218342.540.26数据可信
加速6月-供试品溶液-2024110321批-富马酸比索洛尔-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%
5min189232-8923295.90198.682.4995.9098.682.49
292897-9289799.84099.84
395311-95311102.435102.43
492560-9256099.47899.48
589504-8950496.19496.19
691411-9141198.24398.24
10min190689-9068997.467100.322.3197.63100.482.31
294419-94419101.476101.64
396549-96549103.765103.94
494182-94182101.221101.39
591417-9141798.25098.41
692793-9279399.72999.89
15min191330-9133098.156100.462.0498.48100.792.04
294474-94474101.535101.87
396336-96336103.536103.88
494146-94146101.183101.52
591588-9158898.43498.76
692949-9294999.896100.23
20min191311-9131198.136100.392.0698.62100.892.06
294467-94467101.528102.03
396390-96390103.594104.11
493949-93949100.971101.47
591592-9159298.43898.93
692743-9274399.675100.17
30min191391-9139198.222100.331.9798.87101.001.97
294488-94488101.550102.22
396276-96276103.472104.16
493613-93613100.610101.28
591788-9178898.64899.30
692560-9256099.478100.14
45min191629-9162998.478100.651.9699.29101.481.96
294758-94758101.840102.68
396447-96447103.656104.52
494144-94144101.181102.02
591972-9197298.84699.66
692929-9292999.875100.70
极限191425-9142598.258100.482.0299.24101.492.02
294649-94649101.723102.74
396453-96453103.662104.70
493834-93834100.847101.86
591853-9185398.71899.70
692757-9275799.690100.68
富马酸比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.065172151118508035105051473512330.71
214.065079050656507230.19
单位质量响应值RSD%判断
3643.883607.610.71数据可信
加速6月-供试品溶液-2024110321批-左氨氯地平-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%
5min140324-4032470.22172.692.6770.2272.692.67
242193-4219373.47673.48
340910-4091071.24271.24
443540-4354075.82275.82
541560-4156072.37372.37
641926-4192673.01173.01
10min147095-4709582.01283.141.5082.1383.261.50
248544-4854484.53684.66
347712-4771283.08783.21
447183-4718382.16682.29
548699-4869984.80684.93
647225-4722582.23982.36
15min148094-4809483.75286.242.2284.0186.502.21
250368-5036887.71287.98
348980-4898085.29585.55
451016-5101688.84089.10
549922-4992286.93587.20
648770-4877084.92985.19
20min148515-4851584.48587.662.2884.8888.062.27
250160-5016087.35087.76
350456-5045687.86588.26
451441-5144189.58089.99
551638-5163889.92490.33
649821-4982186.75987.16
30min149769-4976986.66988.401.6787.2088.951.67
250429-5042987.81888.37
351324-5132489.37789.92
451720-5172090.06690.63
551451-5145189.59890.15
649891-4989186.88187.43
45min150002-5000287.07588.271.9687.7588.961.95
250964-5096488.75089.45
349354-4935485.94686.64
450271-5027187.54388.25
551598-5159889.85490.56
651941-5194190.45191.14
极限149005-4900585.33889.192.2786.1690.032.26
252086-5208690.70491.55
351639-5163989.92590.76
451816-5181690.23491.09
551875-5187590.33691.19
650878-5087888.60089.44
富马酸比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048382183922839118377883862838590.08
210.068414683984840650.14
单位质量响应值RSD%判断
8352.498356.360.04数据可信
加速6月-供试品溶液-2024110421批-富马酸比索洛尔-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%
5min196603-96603103.86099.293.06103.8699.293.06
288774-8877495.44395.44
394293-94293101.376101.38
492244-9224499.17399.17
592070-9207098.98698.99
690120-9012096.89096.89
10min198197-98197105.573101.112.83105.75101.282.83
290416-9041697.20897.37
395732-95732102.923103.09
493898-93898100.952101.12
593016-93016100.003100.17
693024-93024100.012100.17
15min197769-97769105.113101.072.49105.46101.402.49
291031-9103197.86998.19
395481-95481102.653102.99
493760-93760100.803101.14
593242-93242100.246100.58
692769-9276999.738100.07
20min197859-97859105.210101.042.53105.73101.542.53
291063-9106397.90498.39
395480-95480102.652103.16
493603-93603100.634101.14
593118-93118100.113100.61
692762-9276299.730100.22
30min198142-98142105.514101.332.41106.21102.012.41
291731-9173198.62299.27
395519-95519102.694103.38
493821-93821100.869101.54
593377-93377100.391101.06
692934-9293499.915100.58
45min197939-97939105.296101.102.37106.17101.942.37
291830-9183098.72899.54
395297-95297102.456103.31
493302-93302100.311101.15
593051-93051100.041100.87
692798-9279899.769100.60
极限197777-97777105.122100.852.35106.17101.862.35
291908-9190898.81299.79
394927-94927102.058103.08
493063-93063100.054101.06
592805-9280599.776100.78
692364-9236499.302100.30
富马酸比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.065159251768510045119551315513750.60
214.065247851836521570.88
单位质量响应值RSD%判断
3653.983709.601.07数据可信
加速6月-供试品溶液-2024110421批-左氨氯地平-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%
5min141273-4127370.78270.582.0370.7870.582.03
241071-4107170.43570.44
341085-4108570.45970.46
440391-4039169.26969.27
540426-4042669.32969.33
642684-4268473.20273.20
10min147688-4768881.78380.305.9781.9080.425.96
248209-4820982.67782.79
347363-4736381.22681.34
447657-4765781.73081.85
541220-4122070.69170.81
648809-4880983.70683.83
15min149817-4981785.43585.010.6785.6985.260.67
249590-4959085.04585.30
349537-4953784.95485.21
449146-4914684.28484.54
549281-4928184.51584.75
650037-5003785.81286.07
20min151324-5132488.01985.631.9688.4286.021.96
249287-4928784.52684.92
350399-5039986.43386.83
448506-4850683.18683.58
549766-4976685.34785.72
650295-5029586.25486.66
30min152095-5209589.34187.091.8789.8887.631.87
251140-5114087.70388.24
350896-5089687.28587.82
449662-4966285.16985.70
549691-4969185.21885.73
651224-5122487.84888.40
45min152969-5296990.84087.892.2591.5388.572.24
251352-5135288.06788.75
349891-4989185.56186.25
450977-5097787.42488.10
550228-5022886.13986.80
652071-5207189.30089.99
极限153456-5345691.67587.344.0792.5288.174.04
251007-5100787.47588.31
347113-4711380.79781.62
451388-5138888.12988.95
551214-5121487.83088.63
651396-5139688.14388.99
富马酸比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048343883501833578333683107833480.18
210.068331183243832770.06
单位质量响应值RSD%判断
8301.598278.030.21数据可信
长期6月-供试品溶液-2024110221批-富马酸比索洛尔-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%
5min189004-8900496.43696.981.5796.4496.981.57
290870-9087098.45898.46
388508-8850895.89895.90
490826-9082698.41098.41
590396-9039697.94497.94
687460-8746094.76394.76
10min190805-9080598.38798.981.6198.5599.141.60
291505-9150599.14699.31
390402-9040297.95198.11
493193-93193100.975101.14
592827-92827100.578100.74
689376-8937696.83997.00
15min190778-9077898.35898.831.6998.6899.161.69
291541-9154199.18599.51
391102-9110298.70999.03
492933-92933100.693101.03
592403-92403100.119100.45
688537-8853795.93096.25
20min190537-9053798.09798.891.4498.5999.381.44
291553-9155399.19899.69
391051-9105198.65499.14
492799-92799100.548101.05
592453-92453100.173100.67
689220-8922096.67097.15
30min190385-9038597.93298.991.4998.5899.641.49
291734-9173499.394100.05
391292-9129298.91599.57
492912-92912100.670101.34
592536-92536100.263100.93
689295-8929596.75197.39
45min190375-9037597.92198.751.4998.7499.571.49
291345-9134598.97299.80
391144-9114498.75599.57
492586-92586100.317101.15
592422-92422100.139100.97
688948-8894896.37597.18
极限189459-8945996.92998.471.8097.9199.461.80
291118-9111898.72699.72
391056-9105698.65999.64
492712-92712100.454101.46
592405-92405100.121101.12
688525-8852595.91796.88
富马酸比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.065067150881504865059950821506920.32
214.065098850866509270.17
单位质量响应值RSD%判断
3605.413622.120.33数据可信
长期6月-供试品溶液-2024110221批-左氨氯地平-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%
5min134056-3405659.50158.975.0159.5058.975.00
235160-3516061.43061.43
336042-3604262.97162.97
431981-3198155.87655.88
531828-3182855.60955.61
633444-3344458.43258.43
10min145519-4551979.52979.520.8079.6379.620.80
246233-4623380.77780.88
345234-4523479.03179.14
445391-4539179.30579.40
545355-4535579.24379.34
645353-4535379.23979.34
15min148177-4817784.17384.741.7484.4084.971.73
249779-4977986.97287.21
348596-4859684.90585.14
447797-4779783.50983.73
549104-4910485.79386.02
647544-4754483.06783.30
20min149738-4973886.90087.711.7987.2788.081.78
250924-5092488.97389.35
349019-4901985.64486.02
449490-4949086.46786.83
550896-5089688.92489.29
651147-5114789.36289.73
30min150172-5017287.65989.281.3488.1889.801.33
251712-5171290.34990.88
350281-5028187.84988.37
451464-5146489.91690.42
551507-5150789.99190.51
651463-5146389.91490.43
45min150245-5024587.78690.091.4788.4590.761.47
252284-5228491.34992.03
351233-5123389.51290.18
451517-5151790.00990.67
551989-5198990.83391.50
652126-5212691.07391.74
极限151100-5110089.28089.391.4590.0990.211.44
252020-5202090.88791.72
351336-5133689.69290.51
451426-5142689.85090.66
551300-5130089.62990.45
649792-4979286.99587.81
富马酸比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048378783766837438366883791837510.06
210.068325783394833260.12
单位质量响应值RSD%判断
8341.738282.900.51数据可信
长期6月-供试品溶液-2024110321批-富马酸比索洛尔-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%
5min189828-8982897.06697.801.7297.0797.801.72
287925-8792595.01095.01
390694-9069498.00298.00
492243-9224399.67699.68
590459-9045997.74897.75
691866-9186699.26899.27
10min191580-9158098.959100.191.0999.12100.361.09
291895-9189599.30099.46
394123-94123101.707101.87
493155-93155100.661100.83
592128-9212899.55299.71
693455-93455100.985101.15
15min191491-9149198.863100.321.0599.19100.651.05
292453-9245399.903100.23
394160-94160101.747102.08
493062-93062100.561100.89
592261-9226199.695100.02
693620-93620101.164101.50
20min191487-9148798.859100.140.9499.35100.640.94
292602-92602100.064100.55
394128-94128101.713102.22
492930-92930100.418100.92
592240-9224099.673100.17
692672-92672100.139100.64
30min191273-9127398.628100.080.9999.28100.750.99
292670-92670100.137100.79
394024-94024101.600102.27
492746-92746100.219100.89
592106-9210699.528100.19
692902-92902100.388101.06
45min191971-9197199.382100.390.85100.20101.220.86
292967-92967100.458101.28
394196-94196101.786102.63
492833-92833100.313101.15
592235-9223599.667100.49
693239-93239100.752101.59
极限191499-9149998.872100.210.9799.86101.210.97
292838-92838100.319101.31
394141-94141101.727102.74
492866-92866100.349101.35
592086-9208699.506100.50
693017-93017100.512101.52
富马酸比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.065132150980509055100050896510200.35
214.065079451205510000.57
单位质量响应值RSD%判断
3628.733627.310.03数据可信
长期6月-供试品溶液-2024110321批-左氨氯地平-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%
5min140975-4097571.30871.523.9871.3171.523.98
243242-4324275.25375.25
341715-4171572.59672.60
442090-4209073.24973.25
538666-3866667.29067.29
639893-3989369.42569.43
10min148880-4888085.06584.882.3585.1885.002.35
249624-4962486.36086.49
349888-4988886.81986.94
449185-4918585.59685.72
546732-4673281.32781.44
648324-4832484.09884.21
15min150628-5062888.10787.692.2888.3787.952.28
250135-5013587.24987.52
351787-5178790.12490.39
451514-5151489.64989.91
549313-4931385.81986.07
648950-4895085.18785.44
20min150573-5057388.01187.915.6688.4288.325.64
252040-5204090.56490.98
352220-5222090.87891.29
452079-5207990.63291.05
551356-5135689.37489.76
644818-4481877.99678.39
30min152444-5244491.26890.821.6891.8291.371.69
251732-5173290.02890.59
353439-5343992.99993.57
452718-5271891.74492.31
550919-5091988.61489.15
651852-5185290.23790.77
45min152741-5274191.78488.174.8092.4988.884.76
250897-5089788.57589.29
345960-4596079.98480.71
452330-5233091.06991.79
550944-5094488.65789.34
651117-5111788.95889.64
极限152580-5258091.50490.761.4092.3691.611.40
251975-5197590.45191.31
352769-5276991.83392.69
452946-5294692.14193.01
551360-5136089.38190.22
651270-5127089.22490.05
富马酸比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048357383625836798356283618836110.06
210.068358383663836230.07
单位质量响应值RSD%判断
8327.798312.430.14数据可信
长期6月-供试品溶液-2024110421批-富马酸比索洛尔-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%
5min191643-9164398.93497.061.9998.9397.061.99
287472-8747294.43194.43
390357-9035797.54597.55
490286-9028697.46997.47
591643-9164398.93498.93
688021-8802195.02395.02
10min192816-92816100.20099.411.84100.3699.571.85
290265-9026597.44697.60
393646-93646101.096101.26
493234-93234100.651100.81
592919-92919100.311100.48
689625-8962596.75596.91
15min192576-9257699.94199.311.91100.2799.641.91
290627-9062797.83798.16
393303-93303100.726101.06
493163-93163100.575100.90
593229-93229100.646100.98
689077-8907796.16396.48
20min192555-9255599.91899.591.83100.42100.081.83
291536-9153698.81899.30
393568-93568101.012101.51
493352-93352100.779101.28
593316-93316100.740101.24
689175-8917596.26996.75
30min192449-9244999.80499.901.75100.47100.561.74
292260-9226099.600100.25
393875-93875101.343102.01
493601-93601101.047101.71
593510-93510100.949101.62
689532-8953296.65597.30
45min192382-9238299.73199.701.83100.56100.521.83
292345-9234599.691100.50
393745-93745101.203102.04
493346-93346100.772101.61
593193-93193100.607101.44
689111-8911196.20097.00
极限192155-9215599.48699.491.79100.48100.481.79
292277-9227799.618100.60
393460-93460100.895101.90
493104-93104100.511101.51
592976-92976100.373101.38
688959-8895996.03697.00
富马酸比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.065115750972509575095751064510210.18
214.065119951040511200.22
单位质量响应值RSD%判断
3628.813635.850.14数据可信
长期6月-供试品溶液-2024110421批-左氨氯地平-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%
5min138990-3899067.77369.102.2667.7769.102.26
239921-3992169.39269.39
338823-3882367.48367.48
441187-4118771.59271.59
540286-4028670.02670.03
639314-3931468.33768.34
10min146785-4678581.32382.351.0681.4482.471.06
248073-4807383.56283.68
347112-4711281.89182.00
447411-4741182.41182.53
547844-4784483.16483.28
647033-4703381.75481.87
15min149872-4987286.68984.902.1386.9485.162.13
249216-4921685.54985.80
348210-4821083.80084.05
448891-4889184.98485.24
549758-4975886.49186.75
647124-4712481.91282.16
20min148152-4815283.69986.492.5584.0986.882.54
250225-5022587.30287.70
348714-4871484.67685.06
451033-5103388.70789.11
551227-5122789.04489.44
649192-4919285.50785.89
30min150574-5057487.90987.442.3288.4487.982.31
250961-5096188.58289.12
349005-4900585.18285.71
451528-5152889.56790.11
551044-5104488.72689.27
648714-4871484.67685.21
45min150478-5047887.74288.301.8788.4288.981.86
250842-5084288.37589.07
351573-5157389.64690.32
450538-5053887.84688.54
552041-5204190.45991.15
649319-4931985.72886.40
极限150674-5067488.08388.601.5088.9189.441.50
250959-5095988.57889.42
351466-5146689.46090.28
450935-5093588.53789.38
552037-5203790.45291.30
649774-4977486.51887.33
富马酸比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048353083510835518358183517835380.04
210.068350583349834270.14
单位质量响应值RSD%判断
8320.528292.940.24数据可信
长期6月-供试品溶液-2024110221批-富马酸比索洛尔-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%
5min186594-8659493.63495.552.8393.6395.552.83
289457-8945796.72996.73
384281-8428191.13391.13
490591-9059197.95697.96
588648-8864895.85595.85
690617-9061797.98497.98
10min188223-8822395.39597.462.4495.5597.622.44
291731-9173199.18899.35
387034-8703494.10994.26
491911-9191199.38399.55
589563-8956396.84497.00
692309-9230999.81399.98
15min188263-8826395.43898.292.3295.7598.612.32
291719-9171999.17599.50
388254-8825495.42995.74
492904-92904100.457100.79
591703-9170399.15899.48
692567-92567100.092100.42
20min188426-8842695.61598.172.0296.0998.652.02
292275-9227599.776100.27
388813-8881396.03396.50
492182-9218299.676100.17
590498-9049897.85598.34
692518-92518100.039100.54
30min188878-8887896.10398.471.6796.7499.121.67
292453-9245399.969100.63
389619-8961996.90597.53
492064-9206499.548100.21
591014-9101498.41399.06
692358-9235899.866100.53
45min188740-8874095.95498.471.5996.7599.281.60
292527-92527100.049100.87
390105-9010597.43098.22
492111-9211199.599100.43
590905-9090598.29599.11
692012-9201299.492100.32
极限188543-8854395.74198.261.4596.6999.241.45
292099-9209999.586100.58
390352-9035297.69798.65
491408-9140898.83999.83
590938-9093898.33199.31
691923-9192399.396100.39
富马酸比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.065150151197513855131551731514260.40
214.065139451466514300.10
单位质量响应值RSD%判断
3657.613657.890.01数据可信
长期6月-供试品溶液-2024110221批-左氨氯地平-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%
5min136416-3641662.85962.204.6262.8662.204.62
236080-3608062.27962.28
338419-3841966.31766.32
434383-3438359.35059.35
533935-3393558.57758.58
636970-3697063.81563.82
10min144358-4435876.56879.602.1176.6779.712.11
246183-4618379.71879.82
347103-4710381.30681.42
445972-4597279.35479.45
546200-4620079.74879.85
646886-4688680.93281.04
15min148038-4803882.92085.071.6583.1585.301.65
249729-4972985.83986.08
350210-5021086.67086.92
449473-4947385.39785.63
548587-4858783.86884.10
649655-4965585.71285.95
20min147233-4723381.53186.063.2781.9086.443.26
248444-4844483.62184.00
351279-5127988.51588.91
450903-5090387.86688.24
550612-5061287.36387.73
650674-5067487.47087.85
30min149372-4937285.22388.151.9785.7388.671.97
250572-5057287.29487.81
351120-5112088.24088.78
451801-5180189.41689.94
552216-5221690.13290.65
651328-5132888.59989.13
45min150309-5030986.84089.401.8287.4990.071.82
251607-5160789.08189.75
352731-5273191.02191.71
451855-5185589.50990.18
552854-5285491.23391.90
651383-5138388.69489.37
极限149951-4995186.22289.322.4787.0290.142.46
252260-5226090.20891.02
352362-5236290.38491.22
450312-5031286.84687.66
552893-5289391.30192.12
652698-5269890.96491.79
富马酸比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048376783692836168353383737836690.12
210.068333983082832100.22
单位质量响应值RSD%判断
8333.578271.370.53数据可信
长期6月-供试品溶液-2024110321批-富马酸比索洛尔-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%
5min188087-8808795.29897.282.7695.3097.282.75
290497-9049797.90597.91
386083-8608393.13093.13
492009-9200999.54199.54
592705-92705100.294100.29
690129-9012997.50797.51
10min189697-8969797.04099.161.9697.2099.321.96
291738-9173899.24899.41
389761-8976197.10997.26
493460-93460101.111101.28
593933-93933101.623101.79
691339-9133998.81698.98
15min189248-8924896.55499.421.8796.8799.741.88
291865-9186599.38599.71
390826-9082698.26198.58
493131-93131100.755101.09
594129-94129101.835102.17
692164-9216499.709100.04
20min189490-8949096.81699.851.8997.30100.341.89
291845-9184599.36499.86
392122-9212299.663100.14
493485-93485101.138101.64
594659-94659102.408102.91
692158-9215899.702100.20
30min189808-8980897.160100.101.8197.80100.761.81
291992-9199299.523100.18
393524-93524101.180101.83
492818-92818100.416101.09
594791-94791102.551103.23
692237-9223799.788100.45
45min189944-8994497.307100.582.0398.11101.412.03
292228-9222899.778100.60
394863-94863102.629103.44
493320-93320100.959101.80
595000-95000102.777103.62
692485-92485100.056100.88
极限189623-8962396.960100.622.1897.93101.622.17
292230-9223099.780100.77
395037-95037102.817103.80
493384-93384101.029102.04
595026-95026102.805103.82
692765-92765100.359101.35
富马酸比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.065219651864518615180551888519230.30
214.065173251385515580.48
单位质量响应值RSD%判断
3692.963667.000.50数据可信
长期6月-供试品溶液-2024110321批-左氨氯地平-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%
5min142805-4280573.44272.082.2373.4472.082.23
242702-4270273.26573.27
342588-4258873.07073.07
440645-4064569.73669.74
541024-4102470.38670.39
642302-4230272.57972.58
10min150033-5003385.84384.001.3085.9784.121.30
249423-4942384.79784.92
348656-4865683.48183.60
448454-4845483.13483.25
548557-4855783.31183.43
648613-4861383.40783.53
15min151170-5117087.79487.281.0988.0687.541.09
250666-5066686.93087.19
351543-5154388.43488.70
450462-5046286.58086.83
550100-5010085.95886.21
651297-5129788.01288.27
20min151302-5130288.02188.341.6288.4388.751.61
250754-5075487.08187.49
352890-5289090.74591.15
452055-5205589.31389.71
550793-5079387.14787.55
651150-5115087.76088.17
30min152749-5274990.50390.061.7491.0690.611.73
253246-5324691.35691.91
353740-5374092.20492.76
451842-5184288.94789.50
551356-5135688.11388.66
652012-5201289.23989.79
45min151499-5149988.35989.781.8189.0790.491.80
253058-5305891.03491.74
353786-5378692.28393.00
452275-5227589.69090.39
552052-5205289.30890.00
651302-5130288.02188.72
极限152702-5270290.42390.211.3691.2891.061.36
253604-5360491.97092.83
352784-5278490.56391.43
451539-5153988.42789.27
552022-5202289.25690.10
652807-5280790.60391.45
富马酸比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048403183986841018392584039840160.08
210.068360983397835030.18
单位质量响应值RSD%判断
8368.138300.500.58数据可信
长期6月-供试品溶液-2024110421批-富马酸比索洛尔-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%
5min191547-9154798.66397.441.9698.6697.441.96
288475-8847595.35295.35
390137-9013797.14397.14
492826-92826100.041100.04
588384-8838495.25495.25
691117-9111798.20098.20
10min195494-95494102.91799.422.35103.0899.582.35
289987-8998796.98297.14
391497-9149798.60998.77
493922-93922101.223101.39
590166-9016697.17597.33
692454-9245499.64199.80
15min195679-95679103.11699.502.24103.4599.832.24
290095-9009597.09897.42
391712-9171298.84199.17
493661-93661100.941101.28
590621-9062197.66597.99
692161-9216199.32599.65
20min195186-95186102.58599.292.08103.0999.782.08
290114-9011497.11997.60
391113-9111398.19598.69
493495-93495100.762101.27
590736-9073697.78998.27
692115-9211599.27599.77
30min195497-95497102.92099.761.82103.60100.421.82
291184-9118498.27298.92
392165-9216599.32999.98
493483-93483100.750101.42
591048-9104898.12598.77
692030-9203099.18499.84
45min195368-95368102.78199.641.86103.63100.461.86
290699-9069997.74998.56
391697-9169798.82599.64
493453-93453100.717101.56
591256-9125698.34999.16
692225-9222599.394100.22
极限195502-95502102.92599.431.94103.95100.421.94
290791-9079197.84898.82
391789-9178998.92499.91
493132-93132100.371101.38
591116-9111698.19999.17
691233-9123398.32599.32
富马酸比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.065212752111520745205952114520970.06
214.065157451854517140.39
单位质量响应值RSD%判断
3705.333678.090.53数据可信
长期6月-供试品溶液-2024110421批-左氨氯地平-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%
5min142535-4253572.74770.313.2372.7570.323.23
240198-4019868.75068.75
339441-3944167.45567.46
442780-4278073.16673.17
540510-4051069.28469.28
641209-4120970.47970.48
10min149731-4973185.05480.537.4485.1880.657.43
240103-4010368.58868.70
348306-4830682.61782.73
448706-4870683.30183.42
548171-4817182.38682.50
647505-4750581.24781.36
15min151301-5130187.73985.242.7088.0085.502.71
247638-4763881.47581.70
350307-5030786.03986.29
450760-5076086.81487.07
548890-4889083.61683.87
650158-5015885.78486.04
20min152353-5235389.53986.722.7889.9587.122.78
248405-4840582.78683.15
350843-5084386.95687.35
451867-5186788.70789.11
549997-4999785.50985.90
650774-5077486.83887.23
30min153378-5337891.29288.202.6291.8588.742.62
250809-5080986.89887.40
351080-5108087.36187.90
453182-5318290.95691.51
550654-5065486.63387.17
650312-5031286.04886.59
45min153842-5384292.08588.842.8892.8089.522.89
250170-5017085.80586.45
350966-5096687.16687.85
453678-5367891.80592.51
551319-5131987.77088.45
651681-5168188.38989.07
极限153636-5363691.73388.712.5392.6089.552.52
251303-5130387.74388.53
352479-5247989.75490.58
452548-5254889.87290.73
551409-5140987.92488.75
649848-4984885.25486.09
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