奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205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)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.311023211024341022961023151023181023370.06
29.281029191030401029800.09
单位质量响应值RSD%判断
10992.1611096.980.68数据可信
加速3月-供试品溶液-2024041311批-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%
5min163560-6356064.61462.122.9264.6162.122.92
259270-5927060.25360.25
362880-6288063.92363.92
461273-6127362.28962.29
559764-5976460.75560.76
659890-5989060.88360.88
10min179293-7929380.60880.163.1680.9780.503.15
275652-7565276.90777.24
378000-7800079.29479.65
483095-8309584.47384.82
579421-7942180.73881.08
677642-7764278.93079.27
15min184310-8431085.70886.174.1086.5286.964.08
281689-8168983.04483.81
383101-8310184.47985.27
491385-9138592.90193.72
585262-8526286.67687.46
682835-8283584.20984.99
20min186484-8648487.91887.782.3789.2089.042.37
285070-8507086.48187.70
384753-8475386.15987.42
490197-9019791.69393.02
586537-8653787.97289.24
685019-8501986.42987.67
30min187320-8732088.76889.172.6990.5490.922.69
285444-8544486.86188.56
387534-8753488.98690.73
491438-9143892.95594.80
589286-8928690.76792.52
685264-8526486.67888.40
45min185973-8597387.39988.483.0289.6690.743.00
285265-8526586.67988.87
385111-8511186.52388.76
491721-9172193.24295.60
588583-8858390.05292.31
685593-8559387.01389.22
60min186106-8610687.53488.542.9590.2891.282.93
285611-8561187.03189.70
386496-8649687.93190.65
491703-9170393.22496.10
588172-8817289.63492.40
684476-8447685.87788.57
极限185785-8578587.20888.553.8290.4491.783.77
284332-8433285.73188.88
388785-8878590.25893.46
492703-9270394.24197.63
587304-8730488.75292.01
683698-8369885.08688.25
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205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)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.311022921023821023621024431022891023540.07
29.281024951025571025260.05
单位质量响应值RSD%判断
10993.9811048.060.35数据可信
长期3月-供试品溶液-2024041311批-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%
5min165542-6554266.77068.177.1566.7768.187.15
271221-7122172.55672.56
359697-5969760.81660.82
464215-6421565.41865.42
568192-6819269.47069.47
672644-7264474.00574.01
10min181054-8105482.57384.172.7782.9484.552.78
285195-8519586.79287.19
381007-8100782.52582.86
480407-8040781.91482.28
582368-8236883.91284.30
685696-8569687.30287.71
15min185321-8532186.92087.922.0487.7588.772.06
286166-8616687.78188.67
384618-8461886.20487.00
484783-8478386.37287.19
588501-8850190.16091.01
688429-8842990.08690.98
20min187840-8784089.48689.461.6990.8090.791.70
287619-8761989.26190.63
386842-8684288.47089.74
485827-8582787.43588.73
590145-9014591.83493.19
688608-8860890.26991.67
30min185578-8557887.18290.182.5488.9992.012.54
289862-8986291.54693.41
386668-8666888.29290.06
487462-8746289.10190.89
590719-9071992.41994.28
690841-9084192.54394.44
45min185387-8538786.98788.333.3389.2890.663.31
285910-8591087.52089.90
384097-8409785.67387.93
484213-8421385.79188.07
590599-9059992.29794.67
690039-9003991.72694.14
60min184673-8467386.26088.342.7689.0491.162.75
287041-8704188.67291.54
385204-8520486.80189.53
484369-8436985.95088.71
590202-9020291.89294.78
688800-8880090.46493.39
极限184219-8421985.79787.372.2789.0590.692.26
285239-8523986.83690.19
385757-8575787.36490.58
483643-8364385.21188.44
589067-8906790.73694.14
686673-8667388.29791.72
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205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)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.311025781025731024311022301023231024270.15
29.281019091020181019640.08
单位质量响应值RSD%判断
11001.8310987.500.10数据可信
中间条件3月-供试品溶液-2024041311批-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%
5min167261-6726168.68568.862.1668.6968.862.15
265391-6539166.77666.78
367556-6755668.98768.99
469160-6916070.62570.62
566324-6632467.72967.73
668882-6888270.34170.34
10min183016-8301684.77485.081.8985.1685.471.88
284719-8471986.51386.88
383335-8333585.10085.48
485508-8550887.31987.71
581436-8143683.16183.54
681908-8190883.64384.03
15min189312-8931291.20389.751.4992.0690.611.48
287854-8785489.71590.57
387147-8714788.99389.85
489620-8962091.51892.40
586462-8646288.29389.13
686961-8696188.80389.66
20min188488-8848890.36289.571.0991.7290.921.08
288763-8876390.64391.99
387426-8742689.27790.63
488003-8800389.86791.25
586100-8610087.92389.25
687485-8748589.33890.69
30min187288-8728889.13790.741.4091.0092.591.38
289369-8936991.26293.12
388508-8850890.38292.23
490906-9090692.83194.72
588984-8898490.86892.69
688088-8808889.95491.80
45min188846-8884690.72889.681.5993.0892.041.56
286672-8667288.50890.87
389523-8952391.41993.77
488706-8870690.58592.99
586057-8605787.87990.20
687122-8712288.96791.31
60min188534-8853490.40988.391.4893.2791.251.44
287566-8756689.42092.27
385786-8578687.60390.46
486614-8661488.44891.35
585595-8559587.40890.22
685263-8526387.06989.91
极限185937-8593787.75787.551.1591.1290.901.15
286072-8607287.89591.24
385349-8534987.15690.50
487411-8741189.26292.66
584622-8462286.41489.71
685028-8502886.82990.15
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