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)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.018812688722883928878688910885870.37
214.058882288578887000.20
单位质量响应值RSD%判断
6323.136313.170.12数据可信
长期24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%
5min177189-7718985.71886.033.5085.7286.043.50
277189-7718985.71885.72
380789-8078989.71689.72
473621-7362181.75681.76
575786-7578684.16084.16
680263-8026389.13289.13
10min182706-8270691.84594.512.7892.7095.372.73
287351-8735197.00397.86
383318-8331892.52593.42
488154-8815497.89598.71
585995-8599595.49896.34
683136-8313692.32393.21
15min179712-7971288.52091.063.5990.3092.873.52
284231-8423193.53995.37
380369-8036989.25091.07
482599-8259991.72693.52
586383-8638395.92897.72
678708-7870887.40589.22
20min181445-8144590.44592.411.8993.1195.131.86
285194-8519494.60897.37
384074-8407493.36496.08
481543-8154390.55493.27
582629-8262991.76094.52
684408-8440893.73596.42
30min179463-7946388.24490.161.5891.8193.801.52
280244-8024489.11192.82
381406-8140690.40194.05
482185-8218591.26794.89
580888-8088889.82693.50
682957-8295792.12495.75
45min181478-8147890.48190.301.8894.9394.841.79
281726-8172690.75795.36
378602-7860287.28891.84
481030-8103089.98494.52
581800-8180090.83995.41
683239-8323992.43796.98
60min178365-7836587.02489.093.3492.3894.543.17
283570-8357092.80598.31
378173-7817386.81192.24
481927-8192790.98096.41
577077-7707785.59491.07
682255-8225591.34496.82
极限177731-7773186.32087.931.3092.5494.271.29
280694-8069489.61196.05
378421-7842187.08793.38
479184-7918487.93494.28
579391-7939188.16494.50
679683-7968388.48894.87
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)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.018921789153894328911589485892800.19
214.058952389715896190.16
单位质量响应值RSD%判断
6372.596378.580.07数据可信
长期24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%
5min176702-7670284.41083.023.6684.4183.023.66
271317-7131778.48478.48
373422-7342280.80180.80
476156-7615683.80983.81
579263-7926387.22987.23
675793-7579383.41083.41
10min185424-8542494.00994.443.4794.8595.283.45
285890-8589094.52295.31
387217-8721795.98296.79
480295-8029588.36489.20
588987-8898797.93098.80
687107-8710795.86196.70
15min185536-8553694.13294.313.3595.9296.093.33
282541-8254190.83692.57
387963-8796396.80398.57
482369-8236990.64792.37
589496-8949698.490100.34
686283-8628394.95496.75
20min184371-8437192.85093.282.4295.5896.002.42
284117-8411792.57095.21
386750-8675095.46898.20
481644-8164489.84992.48
587334-8733496.11198.95
684348-8434892.82595.57
30min185141-8514193.69792.781.7797.3596.431.80
283070-8307091.41894.98
384562-8456293.06096.75
481951-8195190.18793.71
585739-8573994.35598.15
685410-8541093.99397.66
45min182878-8287891.20791.443.1795.8096.023.12
281162-8116289.31893.80
385626-8562694.23198.85
479777-7977787.79492.22
586677-8667795.388100.13
682425-8242590.70895.32
60min180421-8042188.50390.402.7994.0195.902.72
282786-8278691.10696.48
384957-8495793.49599.06
478542-7854286.43591.74
583190-8319091.55097.25
683000-8300091.34196.86
极限181521-8152189.71489.432.0996.1095.822.11
280428-8042888.51194.79
382497-8249790.78897.29
478755-7875586.67092.84
583619-8361992.02298.63
680750-8075088.86595.30
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)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.018886988902892068921889133890660.19
214.058993290037899840.09
单位质量响应值RSD%判断
6357.326404.560.53数据可信
长期24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%
5min179754-7975487.69782.077.1487.7082.077.14
266813-6681373.46773.47
375924-7592483.48583.49
478374-7837486.17986.18
577731-7773185.47285.47
669219-6921976.11276.11
10min179589-7958987.51590.042.0788.3990.862.04
283845-8384592.19592.93
382450-8245090.66191.50
483290-8329091.58592.45
581928-8192890.08790.94
680187-8018788.17388.93
15min177177-7717784.86388.102.6986.6289.822.64
281325-8132589.42491.08
380121-8012188.10089.84
483510-8351091.82793.60
579041-7904186.91388.67
679532-7953287.45289.10
20min178332-7833286.13390.163.0688.7392.762.96
284664-8466493.09695.65
381689-8168989.82492.45
483303-8330391.59994.29
579866-7986687.82090.44
684129-8412992.50795.02
30min176384-7638483.99188.393.1387.4591.893.03
283464-8346491.77695.26
380421-8042188.43091.95
482205-8220590.39294.00
578847-7884786.69990.20
680981-8098189.04692.49
45min175443-7544382.95687.372.8187.2691.762.71
280750-8075088.79293.19
380250-8025088.24292.65
480385-8038588.39092.91
578378-7837886.18390.55
681548-8154889.66994.00
60min176627-7662784.25887.032.6789.3992.302.56
281931-8193190.09095.38
377146-7714684.82990.12
480160-8016088.14393.54
578336-7833686.13791.37
680702-8070288.73993.97
极限174511-7451181.93185.892.8487.9192.022.76
279609-7960987.53793.73
378073-7807385.84891.98
480891-8089188.94795.23
576935-7693584.59790.69
678630-7863086.46192.58
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)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.019052990339902098999889432901010.47
214.058988789847898670.04
单位质量响应值RSD%判断
6431.196396.230.39数据可信
长期24月-供试品溶液-FA2515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%
5min175186-7518682.25181.143.9982.2581.143.99
274849-7484981.88281.88
369281-6928175.79175.79
477085-7708584.32884.33
576542-7654283.73483.73
672102-7210278.87778.88
10min180689-8068988.27187.183.0189.0987.983.01
279076-7907686.50687.32
375501-7550182.59583.35
481767-8176789.45090.29
581947-8194789.64790.48
679144-7914486.58187.37
15min180991-8099188.60187.463.3690.3189.143.35
278782-7878286.18587.87
374974-7497482.01983.60
481839-8183989.52991.27
581277-8127788.91490.65
681802-8180289.48891.14
20min181239-8123988.87288.042.6991.4690.602.69
280780-8078088.37090.92
377559-7755984.84787.25
482003-8200389.70892.34
583062-8306290.86793.49
678222-7822285.57288.12
30min177560-7756084.84885.092.7088.3388.532.64
278685-7868586.07889.51
375943-7594383.07986.33
481421-8142189.07192.60
575724-7572482.83986.37
677362-7736284.63188.04
45min179039-7903986.46687.262.6290.7991.552.61
280392-8039287.94692.24
376873-7687384.09688.18
482525-8252590.27994.70
581430-8143089.08193.44
678349-7834985.71189.96
60min178340-7834085.70186.812.1090.8991.972.09
280320-8032087.86793.04
376740-7674083.95188.87
481264-8126488.90094.22
578986-7898686.40891.66
680450-8045088.00993.12
极限179571-7957187.04886.752.0593.1092.782.04
280825-8082588.41994.47
376342-7634283.51589.28
479043-7904386.47092.68
580688-8068888.27094.38
679320-7932086.77392.76
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