苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718418983923838508449584360841630.33
213.778514085494853170.30
单位质量响应值RSD%判断
6138.806195.860.66数据可信
供试品溶液-2023080921批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163447-6344771.58976.405.1271.5976.405.12
268567-6856777.36677.37
371584-7158480.77080.77
468468-6846877.25477.25
570612-7061279.67379.67
663577-6357771.73671.74
10min175191-7519184.84087.502.6685.5688.262.67
279665-7966589.88890.66
377922-7792287.92188.73
478940-7894089.07089.84
578762-7876288.86989.67
674793-7479384.39185.11
15min174123-7412383.63586.352.5385.2087.992.53
275450-7545085.13286.80
377185-7718587.09088.78
478612-7861288.70090.36
578716-7871688.81790.50
675080-7508084.71586.28
20min172687-7268782.01584.612.7584.4287.112.76
276057-7605785.81788.34
375998-7599885.75188.31
476977-7697786.85589.41
576129-7612985.89888.47
672071-7207181.32083.73
30min172631-7263181.95183.802.2585.1787.152.27
274425-7442583.97687.36
374182-7418283.70287.12
475958-7595885.70589.12
576258-7625886.04489.48
672186-7218681.44984.67
45min171779-7177980.99082.671.3385.0386.861.39
273725-7372583.18687.41
373578-7357883.02087.27
474231-7423183.75788.03
573935-7393583.42387.72
672380-7238081.66885.70
60min170539-7053979.59181.591.8984.4486.601.91
274019-7401983.51888.57
372558-7255881.86986.95
473121-7312182.50487.62
572818-7281882.16287.29
670818-7081879.90684.76
极限170980-7098080.08982.332.1285.7388.162.09
272769-7276982.10788.00
372284-7228481.56087.46
475676-7567685.38791.33
573312-7331282.72088.67
672774-7277482.11387.76
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718493585109848008450784667848040.28
213.778477884734847560.04
单位质量响应值RSD%判断
6185.566155.120.35数据可信
供试品溶液-2023081021批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150413-5041356.85473.8811.8056.8573.8811.80
271812-7181280.98780.99
365066-6506673.37973.38
468026-6802676.71776.72
567996-6799676.68376.68
669773-6977378.68778.69
10min177005-7700586.84385.932.2587.4186.662.23
277128-7712886.98287.79
373285-7328582.64883.38
477886-7788687.83788.60
575031-7503184.61785.38
676811-7681186.62487.41
15min176361-7636186.11785.311.7587.5586.901.73
275703-7570385.37587.05
374191-7419183.67085.23
476900-7690086.72588.37
573878-7387883.31784.93
676828-7682886.64388.30
20min175407-7540785.04183.782.1087.3486.242.05
273817-7381783.24885.78
373209-7320982.56284.96
476099-7609985.82188.33
571980-7198081.17683.62
675247-7524784.86187.38
30min173947-7394783.39483.311.9486.5486.601.93
273518-7351882.91186.28
371831-7183181.00884.23
475188-7518884.79488.16
573003-7300382.33085.59
675726-7572685.40188.77
45min172231-7223181.45982.631.2185.4486.751.26
273633-7363383.04087.24
372982-7298282.30686.34
473737-7373783.15887.38
572459-7245981.71685.80
674575-7457584.10388.32
60min171944-7194481.13681.451.6485.9386.391.60
271195-7119580.29185.32
372804-7280482.10586.96
472643-7264381.92486.97
570739-7073979.77784.67
673997-7399783.45188.51
极限171257-7125780.36180.782.1785.9786.542.09
271888-7188881.07286.90
371689-7168980.84886.52
470487-7048779.49285.36
570000-7000078.94384.64
674428-7442883.93789.83
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718408484499846508412684012842740.34
213.778450284787846440.24
单位质量响应值RSD%判断
6146.906146.990.01数据可信
供试品溶液-2023081121批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168638-6863877.70174.496.9577.7074.496.95
269551-6955178.73578.73
359879-5987967.78667.79
462347-6234770.58070.58
571167-7116780.56480.56
663228-6322871.57771.58
10min177400-7740087.62087.882.6588.4088.622.68
278553-7855388.92689.71
374690-7469084.55285.23
475989-7598986.02386.73
580399-8039991.01591.82
678739-7873989.13689.85
15min177757-7775788.02487.292.8389.6888.912.84
276438-7643886.53188.21
373437-7343783.13484.66
476876-7687687.02788.59
579965-7996590.52492.24
678157-7815788.47790.08
20min175213-7521385.14485.153.1187.6887.653.09
274706-7470684.57187.11
371017-7101780.39482.75
477642-7764287.89490.33
577039-7703987.21289.83
675706-7570685.70388.19
30min173206-7320682.87284.232.9986.2687.582.97
275366-7536685.31888.71
370743-7074380.08483.24
474185-7418583.98187.30
576061-7606186.10489.60
676871-7687187.02190.37
45min171691-7169181.15782.821.2885.3787.011.28
273369-7336983.05787.30
372784-7278482.39586.35
472892-7289282.51786.67
573881-7388183.63787.99
674353-7435384.17188.39
60min172709-7270982.31081.751.1387.3486.771.17
271779-7177981.25786.33
371495-7149580.93685.72
471227-7122780.63285.61
573070-7307082.71987.91
673013-7301382.65487.71
极限169375-6937578.53680.141.9284.3885.981.82
269583-6958378.77184.66
371356-7135680.77886.37
469913-6991379.14584.93
571868-7186881.35887.38
672664-7266482.25988.15
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718461384400843898466284656845440.17
213.778546285422854420.04
单位质量响应值RSD%判断
6166.596204.940.44数据可信
供试品溶液-2023081211批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168053-6805376.55674.197.4076.5674.197.41
263525-6352571.46271.46
358779-5877966.12366.12
473194-7319482.34082.34
564525-6452572.58772.59
667635-6763576.08676.09
10min177918-7791887.65485.584.1588.4286.324.17
275111-7511184.49685.21
370082-7008278.83979.50
478462-7846288.26689.09
577367-7736787.03487.76
677490-7749087.17287.93
15min176986-7698686.60585.013.4488.2586.603.48
274623-7462383.94785.51
370819-7081979.66881.12
477965-7796587.70789.41
575858-7585885.33786.93
677139-7713986.77888.41
20min178691-7869188.52384.823.9191.0387.263.92
275405-7540584.82787.23
369950-6995078.69080.94
476956-7695686.57289.15
575406-7540684.82887.28
675969-7596985.46187.96
30min176083-7608385.59083.543.2788.9886.843.30
274706-7470684.04187.29
369540-6954078.22981.26
475780-7578085.24988.70
575376-7537684.79488.09
674078-7407883.33486.69
45min177146-7714686.78582.992.8591.0387.122.83
273664-7366482.86886.96
371437-7143780.36384.18
473771-7377182.98987.29
574844-7484484.19688.34
671779-7177980.74884.94
60min176083-7608385.59082.102.6390.7187.062.48
272512-7251281.57286.49
374133-7413383.39688.02
472461-7246181.51586.65
572249-7224981.27786.26
670460-7046079.26484.26
极限176532-7653286.09581.583.0092.0787.362.92
270955-7095579.82185.55
371914-7191480.90086.35
472997-7299782.11888.06
570441-7044179.24385.04
672289-7228981.32287.11
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718610886047860288609586437861430.20
213.778601086001860060.01
单位质量响应值RSD%判断
6283.226245.900.43数据可信
供试品溶液-2023080921批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min171543-7154379.47082.625.3379.4782.625.33
276500-7650084.97684.98
368075-6807575.61875.62
475063-7506383.38083.38
575864-7586484.27084.27
679210-7921087.98787.99
10min181034-8103490.01391.362.6190.8192.192.63
284549-8454993.91794.77
378892-7889287.63388.39
482920-8292092.10892.94
581782-8178290.84391.69
684311-8431193.65394.53
15min180790-8079089.74290.002.2191.4491.742.21
280920-8092089.88691.67
378676-7867687.39389.03
483900-8390093.19694.95
579911-7991188.76590.52
681965-8196591.04792.86
20min179120-7912087.88788.081.1590.4890.721.18
278552-7855287.25689.94
378302-7830286.97889.48
479814-7981488.65791.34
579204-7920487.98090.62
680794-8079489.74692.47
30min177275-7727585.83786.181.2889.3189.701.31
277182-7718285.73489.29
376351-7635184.81188.19
477494-7749486.08089.65
577911-7791186.54490.06
679314-7931488.10291.73
45min176656-7665685.15084.771.6789.4889.151.67
276343-7634384.80289.22
375009-7500983.32087.54
476191-7619184.63389.07
575156-7515683.48387.87
678529-7852987.23091.74
60min175761-7576184.15583.261.0889.3488.501.08
275416-7541683.77289.04
374185-7418582.40587.46
474026-7402682.22887.51
574536-7453682.79588.01
675832-7583284.23489.61
极限174174-7417482.39381.931.1788.4287.991.11
273434-7343481.57187.67
374312-7431282.54688.43
473963-7396382.15888.26
572160-7216080.15586.20
674489-7448982.74288.96
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718624185985860718589886200860790.17
213.778588185751858160.11
单位质量响应值RSD%判断
6278.566232.100.53数据可信
供试品溶液-2023081021批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170296-7029678.20077.214.5078.2077.214.50
266632-6663274.12474.12
367928-6792875.56675.57
471104-7110479.09979.10
574345-7434582.70582.70
666122-6612273.55773.56
10min176178-7617884.74485.583.7185.5386.353.72
274977-7497783.40884.15
376232-7623284.80485.56
477655-7765586.38787.18
582241-8224191.48992.32
674271-7427182.62283.36
15min175287-7528783.75384.413.0985.3886.043.10
274053-7405382.38083.96
374196-7419682.53984.14
477757-7775786.50088.16
579727-7972788.69290.43
674272-7427282.62484.19
20min174657-7465783.05284.003.7685.5286.483.75
273439-7343981.69784.10
373842-7384282.14584.57
475620-7562084.12386.64
581095-8109590.21492.84
674427-7442782.79685.18
30min174162-7416282.50183.822.8685.8087.132.89
273195-7319581.42584.64
374141-7414182.47885.73
476497-7649785.09988.46
579124-7912488.02191.55
674977-7497783.40886.62
45min173699-7369981.98682.841.6586.1186.991.72
272831-7283181.02185.05
374214-7421482.55986.63
475091-7509183.53587.75
576412-7641285.00489.42
674566-7456682.95187.00
60min172577-7257780.73880.971.7185.6885.951.75
271016-7101679.00183.84
372605-7260580.76985.67
472303-7230380.43385.48
574714-7471483.11588.38
673511-7351181.77786.66
极限173478-7347881.74081.451.3387.4987.241.27
272149-7214980.26285.89
372688-7268880.86186.57
472671-7267180.84386.69
573396-7339681.64987.74
674906-7490683.32989.03
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718549185536855918568485701856010.11
213.778676186599866800.14
单位质量响应值RSD%判断
6243.696294.840.58数据可信
供试品溶液-2023081121批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162709-6270969.60572.145.5069.6172.145.50
263677-6367770.68070.68
369116-6911676.71776.72
462558-6255869.43869.44
561960-6196068.77468.77
669954-6995477.64777.65
10min174329-7432982.50386.293.7283.2087.023.70
273816-7381681.93482.64
380240-8024089.06489.83
479930-7993088.72089.41
579012-7901287.70188.39
679141-7914187.84588.62
15min174490-7449082.68285.562.9384.2087.152.93
274011-7401182.15083.68
379326-7932688.05089.71
477837-7783786.39787.98
578484-7848487.11588.68
678373-7837386.99288.65
20min172956-7295680.97983.452.3083.3385.902.31
273609-7360981.70484.05
377577-7757786.10988.65
475388-7538883.67986.12
576482-7648284.89387.33
675101-7510183.36085.89
30min172881-7288180.89683.452.7784.0586.732.77
272268-7226880.21683.38
377107-7710785.58788.99
476465-7646584.87488.16
576662-7666285.09388.38
675713-7571384.04087.40
45min174401-7440182.58382.261.7986.5586.371.80
271870-7187079.77483.74
375871-7587184.21588.47
474192-7419282.35186.48
574697-7469782.91287.05
673622-7362281.71985.92
60min172445-7244580.41281.462.2785.2086.392.23
271727-7172779.61584.38
374602-7460282.80687.90
475959-7595984.31389.27
573647-7364781.74686.71
671951-7195179.86484.88
极限174038-7403882.18082.172.3087.7887.922.19
273778-7377881.89287.45
375622-7562283.93989.86
475992-7599284.34990.15
573518-7351881.60387.39
671246-7124679.08184.90
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718699586874869198675086466868010.24
213.778575185735857430.02
单位质量响应值RSD%判断
6331.226226.801.18数据可信
供试品溶液-2023081211批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161597-6159768.26971.272.7068.2771.282.70
265424-6542472.51072.51
366448-6644873.64573.65
465146-6514672.20272.20
563886-6388670.80670.81
663352-6335270.21470.21
10min171599-7159979.35482.444.5980.0483.154.57
277986-7798686.43387.16
378887-7888787.43188.17
473768-7376881.75882.48
573708-7370881.69182.40
670352-7035277.97278.67
15min169557-6955777.09181.324.1878.5782.864.16
278079-7807986.53688.13
374895-7489583.00784.62
472965-7296580.86882.41
574048-7404882.06883.59
670684-7068478.34079.82
20min171273-7127378.99380.592.7081.2482.942.71
275816-7581684.02886.48
373161-7316181.08583.53
473366-7336681.31283.66
572561-7256180.42082.77
670106-7010677.69979.96
30min171736-7173679.50680.973.6982.5484.123.66
277040-7704085.38488.68
374616-7461682.69885.95
471871-7187179.65582.82
573781-7378181.77284.92
669288-6928876.79379.83
45min172711-7271180.58681.012.0184.4284.982.05
274200-7420082.23786.39
374528-7452882.60086.68
472251-7225180.07784.03
574138-7413882.16886.14
670743-7074378.40582.22
60min171843-7184379.62479.991.0284.2684.771.10
272615-7261580.48085.45
372430-7243080.27585.18
472828-7282880.71685.47
572501-7250180.35485.14
670837-7083778.50983.10
极限175668-7566883.86483.022.1489.3088.591.91
271802-7180279.57985.36
375492-7549283.66989.38
476378-7637884.65190.22
574985-7498583.10788.70
675090-7509083.22388.60
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