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100546-202405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%
113.948826387429874298718687071874760.54
214.018795187813878820.12
单位质量响应值RSD%判断
6275.186272.810.03数据可信
中间条件36月-供试品溶液-2022032901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%
5min171377-7137779.82286.125.2179.8286.125.21
272917-7291781.54481.54
377827-7782787.03587.04
480126-8012689.60689.61
581455-8145591.09291.09
678345-7834587.61487.61
10min186438-8643896.66595.813.8597.4696.673.80
289494-89494100.083100.90
380807-8080790.36891.24
485669-8566995.80596.70
583029-8302992.85393.76
688586-8858699.06799.94
15min185313-8531395.40794.674.2397.1796.494.17
287923-8792398.326100.14
379565-7956588.97990.75
481672-8167291.33593.19
584550-8455094.55496.39
688915-8891599.435101.30
20min185603-8560395.73194.694.5398.4597.464.45
289966-89966100.610103.41
378539-7853987.83190.50
482799-8279992.59595.36
584607-8460794.61797.40
686528-8652896.76699.63
30min184214-8421494.17893.853.9797.8597.563.91
288823-8882399.332103.14
379504-7950488.91192.45
483035-8303592.85996.55
581619-8161991.27695.01
686323-8632396.536100.37
45min184249-8424994.21791.793.1198.8396.443.08
284896-8489694.94199.74
378214-7821487.46891.90
480386-8038689.89794.52
581375-8137591.00395.65
683327-8332793.18697.98
60min182736-8273692.52591.692.3898.0997.262.40
283276-8327693.12998.88
379282-7928288.66293.97
480486-8048690.00995.53
581520-8152091.16596.72
684624-8462494.636100.36
极限182833-8283392.63391.903.4699.1298.383.41
285070-8507095.135101.81
377051-7705186.16792.36
482711-8271192.49798.92
581201-8120190.80897.27
684176-8417694.135100.81
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100546-202405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%
113.948828988442880978807888466882740.21
214.018810488046880750.05
单位质量响应值RSD%判断
6332.426286.580.52数据可信
中间条件36月-供试品溶液-2022033001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%
5min181198-8119890.29588.907.5290.3088.907.52
268192-6819275.83275.83
382820-8282092.09992.10
485456-8545695.03095.03
581010-8101090.08690.09
680976-8097690.04890.05
10min185945-8594595.57495.411.1896.4896.301.14
286956-8695696.69897.46
386735-8673596.45297.37
485901-8590195.52596.48
584390-8439093.84594.75
684880-8488094.39095.29
15min186633-8663396.33995.080.9098.2096.920.92
284489-8448993.95595.68
385990-8599095.62497.51
485341-8534194.90296.81
585620-8562095.21397.05
684930-8493094.44596.29
20min184613-8461394.09393.191.6196.9195.981.60
282261-8226191.47794.14
385465-8546595.04097.88
482084-8208491.28094.13
584298-8429893.74296.53
684108-8410893.53196.32
30min184056-8405693.47393.591.1397.2497.321.08
284350-8435093.80097.38
383261-8326192.58996.38
484764-8476494.26198.03
585550-8555095.13598.86
682998-8299892.29796.02
45min181826-8182690.99391.352.0095.6996.011.88
283154-8315492.47096.99
383977-8397793.38598.10
479197-7919788.07092.78
582639-8263991.89896.58
682094-8209491.29295.94
60min181284-8128490.39190.671.4996.0096.251.40
282317-8231791.53996.98
382972-8297292.26897.92
479399-7939988.29593.89
581562-8156290.70096.30
681702-8170290.85696.42
极限181287-8128790.39490.251.1296.9196.741.04
281334-8133490.44696.80
381493-8149390.62397.20
481173-8117390.26796.74
579471-7947188.37594.88
682203-8220391.41397.88
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100546-202405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%
113.948872888511885348838688702885720.17
214.018842088615885180.16
单位质量响应值RSD%判断
6353.806318.200.40数据可信
中间条件36月-供试品溶液-2022033101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%
5min171086-7108678.71987.3510.5378.7287.3510.53
279026-7902687.51287.51
374375-7437582.36182.36
483823-8382392.82492.82
592803-92803102.768102.77
672153-7215379.90179.90
10min189269-8926998.85598.042.6999.6498.922.65
290369-90369100.073100.95
390630-90630100.362101.19
484405-8440593.46894.40
589430-8943099.033100.06
687120-8712096.47597.27
15min189595-8959599.21697.824.58100.9999.684.47
287660-8766097.07398.95
395302-95302105.535107.36
482973-8297391.88393.75
587043-8704396.39098.41
687444-8744496.83498.60
20min188311-8831197.79495.093.40100.5697.923.33
283752-8375292.74595.59
387753-8775397.176100.06
480969-8096989.66392.45
587912-8791297.352100.33
686529-8652995.82098.55
30min186603-8660395.90294.632.3499.6598.412.31
284966-8496694.09097.86
388243-8824397.718101.57
482285-8228591.12194.80
585781-8578194.99298.95
684840-8484093.95097.64
45min186108-8610895.35492.762.47100.0697.492.40
282275-8227591.11095.82
385673-8567394.87399.70
480693-8069389.35893.95
583419-8341992.37697.28
684434-8443493.50098.13
60min185729-8572994.93592.443.31100.5998.103.22
281601-8160190.36395.99
386570-8657095.866101.65
479092-7909287.58593.07
584276-8427693.32699.15
683598-8359892.57598.14
极限184351-8435193.40991.432.55100.0298.012.50
282895-8289591.79698.33
384583-8458393.665100.40
478750-7875087.20693.57
582624-8262491.49698.26
682163-8216390.98697.48
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