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%
110.078508086156853028541485178854260.50
210.088498085910854450.77
单位质量响应值RSD%判断
8483.228476.690.06数据可信
中间条件3月-供试品溶液-2023101321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%
5min195059-95059100.687100.691.63100.69100.691.63
293514-9351499.05099.05
395175-95175100.810100.81
493122-9312298.63598.64
596619-96619102.339102.34
696874-96874102.609102.61
10min195751-95751101.420100.362.47101.59100.522.47
293755-9375599.30699.47
391001-9100196.38996.56
493897-9389799.45699.62
597110-97110102.859103.03
696971-96971102.712102.88
15min195444-95444101.095101.071.53101.43101.401.53
294030-9403099.59799.93
395451-95451101.102101.43
493535-9353599.07399.40
597051-97051102.797103.14
696989-96989102.731103.07
20min195416-95416101.065100.921.62101.57101.421.62
293745-9374599.29599.79
395465-95465101.117101.61
493247-9324798.76899.26
596978-96978102.720103.23
696824-96824102.556103.07
30min195314-95314100.957100.821.48101.63101.491.48
293632-9363299.17599.84
395487-95487101.140101.81
493394-9339498.92399.58
596652-96652102.374103.06
696607-96607102.327103.01
45min195494-95494101.148100.871.53101.99101.711.53
293559-9355999.09899.93
395825-95825101.498102.33
493316-9331698.84199.67
596648-96648102.370103.23
696524-96524102.239103.09
极限195550-95550101.207100.711.52102.22101.721.52
293429-9342998.96099.95
395282-95282100.923101.93
493237-9323798.75799.75
596394-96394102.101103.13
696601-96601102.320103.35
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%
114.715304952893531065320653097530700.22
214.695338952697530430.93
单位质量响应值RSD%判断
3607.753610.820.07数据可信
中间条件3月-供试品溶液-2023101321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%
5min142737-4273774.76173.451.9474.7673.451.94
240881-4088171.51471.51
342017-4201773.50173.50
441749-4174973.03273.03
541475-4147572.55372.55
643073-4307375.34875.35
10min150014-5001487.49087.074.0487.6287.204.03
250707-5070788.70388.82
345768-4576880.06380.19
451188-5118889.54489.67
550178-5017887.77787.90
650799-5079988.86488.99
15min152220-5222091.34991.491.1391.6291.751.13
252630-5263092.06792.33
352261-5226191.42191.68
452813-5281392.38792.66
552668-5266892.13392.40
651194-5119489.55589.83
20min152260-5226091.41992.681.3391.8493.101.33
253978-5397894.42594.85
353325-5332593.28293.69
452286-5228691.46591.89
553444-5344493.49193.91
652602-5260292.01892.44
30min153786-5378694.08993.311.9594.6693.891.93
253512-5351293.61094.19
354318-5431895.02095.58
454174-5417494.76895.35
552677-5267792.14992.73
651591-5159190.24990.83
45min152934-5293492.59994.241.3393.3394.971.32
254052-5405294.55495.29
354631-5463195.56796.29
454516-5451695.36696.10
554031-5403194.51895.25
653077-5307792.84993.58
极限153904-5390494.29595.531.2195.1896.421.20
255082-5508296.35697.25
355648-5564897.34698.23
454646-5464695.59396.49
554142-5414294.71295.60
654224-5422494.85595.74
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%
110.078489584719849458479584908848520.11
210.088514784996850720.13
单位质量响应值RSD%判断
8426.228439.680.12数据可信
中间条件3月-供试品溶液-2023101322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%
5min194660-94660100.82399.312.34100.8299.302.34
294173-94173100.304100.30
391524-9152497.48397.48
496451-96451102.731102.73
591356-9135697.30497.30
691256-9125697.19897.20
10min195312-95312101.518100.022.45101.69100.182.45
294687-94687100.852101.02
391701-9170197.67297.83
497432-97432103.776103.95
592560-9256098.58698.75
691731-9173197.70397.87
15min195069-95069101.25999.872.36101.60100.202.36
294403-94403100.549100.88
391524-9152497.48397.81
497243-97243103.574103.92
592409-9240998.42698.75
691941-9194197.92798.25
20min195031-95031101.21899.652.28101.72100.142.28
294319-94319100.460100.96
391418-9141897.37097.86
496712-96712103.009103.53
592144-9214498.14398.63
691712-9171297.68398.17
30min194768-94768100.93899.632.33101.61100.302.33
294330-94330100.472101.14
391493-9149397.45098.10
496936-96936103.247103.94
592036-9203698.02898.68
691679-9167997.64898.30
45min194888-94888101.06699.532.27101.91100.362.27
294030-94030100.152100.99
391686-9168697.65698.47
496697-96697102.993103.85
591911-9191197.89598.71
691468-9146897.42398.24
极限194676-94676100.84099.232.30101.85100.222.30
293979-93979100.098101.10
390933-9093396.85497.83
496283-96283102.552103.58
591732-9173297.70598.69
691366-9136697.31598.29
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%
114.715281753060531025292453040529890.22
214.695236852523524460.21
单位质量响应值RSD%判断
3602.243570.180.64数据可信
中间条件3月-供试品溶液-2023101322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%
5min141595-4159573.23372.901.9373.2372.901.93
241608-4160873.25573.26
340742-4074271.73171.73
441065-4106572.29972.30
540624-4062471.52371.52
642795-4279575.34575.35
10min152532-5253292.48888.972.1392.6189.092.12
250072-5007288.15788.28
350011-5001188.05088.17
450865-5086589.55389.67
549502-4950287.15487.27
650226-5022688.42888.55
15min154536-5453696.01792.612.3996.2992.872.38
252724-5272492.82693.10
351362-5136290.42890.69
453499-5349994.19194.46
552088-5208891.70791.97
651381-5138190.46290.73
20min155751-5575198.15694.052.7298.5994.482.71
253609-5360994.38594.81
351905-5190591.38491.80
454345-5434595.68096.11
552478-5247892.39392.81
652434-5243492.31692.74
30min155855-5585598.33994.132.5698.9494.712.56
252461-5246192.36392.94
352765-5276592.89993.47
454320-5432095.63696.22
552376-5237692.21492.78
653015-5301593.33993.92
45min155406-5540697.54894.892.1798.3195.632.16
254500-5450095.95396.69
352869-5286993.08293.81
454478-5447895.91596.66
553885-5388594.87095.60
652234-5223491.96492.70
极限156891-56891100.16394.883.37101.0995.783.36
254133-5413395.30796.20
351474-5147490.62691.50
454483-5448395.92396.83
553514-5351494.21795.10
652863-5286393.07193.96
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%
110.078545185521848388482384776850820.44
210.088491285569852400.55
单位质量响应值RSD%判断
8449.068456.350.07数据可信
中间条件3月-供试品溶液-2023101323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%
5min192259-9225998.03699.171.7598.0499.171.75
293633-9363399.49699.50
394842-94842100.781100.78
492418-9241898.20598.21
595510-95510101.491101.49
691296-9129697.01397.01
10min193478-9347899.33199.841.7099.49100.001.70
294268-94268100.171100.34
395072-95072101.025101.19
493053-9305398.88099.04
596207-96207102.231102.40
691666-9166697.40697.57
15min192945-9294598.76599.761.8399.09100.091.83
294118-94118100.012100.34
395241-95241101.205101.54
492969-9296998.79199.12
596343-96343102.376102.72
691656-9165697.39597.72
20min192858-9285898.67399.531.6899.17100.031.68
293989-9398999.874100.37
394708-94708100.639101.14
492899-9289998.71699.21
595991-95991102.002102.51
691543-9154397.27597.76
30min193132-9313298.964100.011.8999.62100.671.89
294684-94684100.613101.28
395305-95305101.273101.95
493203-9320399.03999.70
596647-96647102.699103.38
691712-9171297.45598.10
45min192763-9276398.57299.661.7999.39100.491.79
294133-94133100.028100.86
395143-95143101.101101.94
492941-9294198.76199.58
596136-96136102.156103.01
691616-9161697.35398.16
极限192645-9264598.44699.351.6699.43100.351.67
293801-9380199.675100.68
394593-94593100.516101.53
492570-9257098.36799.35
595826-95826101.827102.85
691563-9156397.29798.27
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%
114.715276452794529865272552218526970.55
214.695313853758534480.83
单位质量响应值RSD%判断
3582.393638.391.10数据可信
中间条件3月-供试品溶液-2023101323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%
5min144533-4453377.88379.561.0977.8879.561.09
245628-4562879.79879.80
345887-4588780.25180.25
445508-4550879.58879.59
545571-4557179.69979.70
645819-4581980.13280.13
10min149511-4951186.58988.962.0586.7289.092.05
250532-5053288.37588.51
351178-5117889.50589.64
450299-5029987.96788.10
552601-5260191.99392.13
651068-5106889.31289.45
15min151792-5179290.57892.771.6590.8593.051.65
252673-5267392.11992.40
353957-5395794.36594.65
453336-5333693.27993.56
553992-5399294.42694.71
652527-5252791.86492.15
20min152597-5259791.98692.951.6292.4193.391.62
252618-5261892.02392.46
352212-5221291.31391.75
453783-5378394.06094.50
554501-5450195.31695.76
653192-5319293.02793.46
30min151640-5164090.31392.981.7090.8993.571.70
253442-5344293.46494.05
352662-5266292.10092.69
453509-5350993.58194.17
554260-5426094.89595.50
653482-5348293.53494.12
45min152491-5249191.80193.931.1692.5394.681.16
253855-5385594.18694.93
353681-5368193.88294.63
453931-5393194.31995.07
554135-5413594.67695.44
654156-5415694.71395.46
极限152739-5273992.23592.981.3393.1293.881.33
252175-5217591.24892.15
353516-5351693.59494.50
452975-5297592.64793.55
554234-5423494.84995.77
653349-5334993.30194.21
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%
110.078555985461849788535085475853650.27
210.088610986372862400.22
单位质量响应值RSD%判断
8477.168555.560.66数据可信
中间条件3月-供试品溶液-2024010421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%
5min192969-9296998.05498.062.2698.0598.052.26
293379-9337998.48798.49
392494-9249497.55397.55
493917-9391799.05499.05
595719-95719100.955100.95
689343-8934394.23094.23
10min193847-9384798.98098.702.3099.1498.862.30
293662-9366298.78598.95
392850-9285097.92998.09
494744-9474499.926100.09
596414-96414101.688101.86
689973-8997394.89495.05
15min193770-9377098.89998.612.2099.2398.942.20
293754-9375498.88299.21
392599-9259997.66497.99
494055-9405599.20099.53
596552-96552101.833102.17
690260-9026095.19795.51
20min193418-9341898.52898.412.1599.0298.902.15
293769-9376998.89899.39
392412-9241297.46797.96
493861-9386198.99599.49
596235-96235101.499102.01
690134-9013495.06495.54
30min193913-9391399.05098.862.3099.7199.522.30
293770-9377098.89999.56
393131-9313198.22598.88
494725-9472599.906100.57
596732-96732102.023102.70
690148-9014895.07995.71
45min193564-9356498.68298.652.1699.5099.472.16
293664-9366498.78799.61
392800-9280097.87698.69
494443-9444399.609100.44
596444-96444101.719102.57
690297-9029795.23696.03
极限193122-9312298.21698.202.0199.2099.182.01
293368-9336898.47599.46
392359-9235997.41198.39
493978-9397899.118100.11
595728-95728100.964101.98
690083-9008395.01095.96
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%
114.715296552589524675300553061528170.52
214.695303652880529580.21
单位质量响应值RSD%判断
3590.553605.040.29数据可信
中间条件3月-供试品溶液-2024010421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%
5min144965-4496578.91079.021.8978.9179.021.89
244405-4440577.92777.93
344433-4443377.97677.98
446229-4622981.12881.13
545904-4590480.55880.56
644236-4423677.63077.63
10min151040-5104089.57188.941.8589.7089.071.85
251013-5101389.52389.65
349443-4944386.76886.90
451899-5189991.07891.21
551023-5102389.54189.68
649671-4967187.16887.30
15min152930-5293092.88891.821.8793.1792.101.87
253630-5363094.11694.40
350981-5098189.46789.74
452798-5279892.65692.94
552044-5204491.33391.62
651556-5155690.47690.75
20min153546-5354693.96993.503.0994.4093.933.08
253905-5390594.59995.03
350073-5007387.87488.30
454320-5432095.32795.77
554573-5457395.77196.21
653255-5325593.45893.88
30min152220-5222091.64292.451.1692.2393.041.16
253120-5312093.22193.81
351961-5196191.18791.76
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552346-5234691.86392.46
652894-5289492.82493.41
45min153969-5396994.71194.131.0395.4694.881.04
253947-5394794.67295.42
352672-5267292.43593.16
453842-5384294.48895.25
554109-5410994.95795.71
653301-5330193.53994.27
极限153229-5322993.41293.131.1194.3294.031.12
253444-5344493.79094.70
352135-5213591.49292.37
453820-5382094.45095.36
553069-5306993.13294.04
652716-5271692.51293.40
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