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%
19.069871698546985769844398439985440.12
29.119899899152990750.11
单位质量响应值RSD%判断
10876.8210875.410.01数据可信
影响因素30天-供试品溶液-2024041311批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136127-3612737.29436.542.6837.2936.542.68
234660-3466035.78035.78
335193-3519336.33036.33
435972-3597237.13437.13
533997-3399735.09535.10
636441-3644137.61837.62
10min155096-5509656.87656.121.9357.0856.321.93
252934-5293454.64454.84
353787-5378755.52555.73
455557-5555757.35257.56
553634-5363455.36755.56
655151-5515156.93357.14
15min165270-6527067.37966.222.4867.9066.732.47
261857-6185763.85564.36
363174-6317465.21565.73
466168-6616868.30668.83
563480-6348065.53166.03
664918-6491867.01567.54
20min169945-6994572.20571.541.6173.1072.421.61
267307-6730769.48270.34
369268-6926871.50672.38
470034-7003472.29773.20
570361-7036172.63473.50
668910-6891071.13672.03
30min178734-7873481.27878.502.2982.5879.782.28
274002-7400276.39377.64
375146-7514677.57478.84
477448-7744879.95081.26
575156-7515677.58478.85
675780-7578078.22879.52
45min182427-8242785.09084.231.7886.8485.941.77
280009-8000982.59484.26
381704-8170484.34486.04
483657-8365786.36088.11
581856-8185684.50186.20
679887-7988782.46884.20
60min186180-8618088.96487.582.1191.1989.772.10
282257-8225784.91587.04
384053-8405386.76988.94
486576-8657689.37391.60
583616-8361686.31788.49
686376-8637689.16791.35
极限189602-8960292.49789.891.6795.2192.561.66
285975-8597588.75391.35
385980-8598088.75891.41
487822-8782290.65993.39
586000-8600088.77891.43
687108-8710889.92292.60
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%
19.069886399154988399907999452990770.26
29.119829598346983200.04
单位质量响应值RSD%判断
10935.6510792.540.94数据可信
影响因素30天-供试品溶液-2024041311批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135846-3584637.04738.272.6137.0538.282.61
238121-3812139.39839.40
335867-3586737.06837.07
437783-3778339.04939.05
537240-3724038.48738.49
637343-3734338.59438.59
10min151546-5154653.27355.222.4953.4855.432.49
254841-5484156.67856.90
352080-5208053.82454.03
454410-5441056.23256.45
554104-5410455.91656.13
653576-5357655.37155.58
15min161423-6142363.48064.222.2263.9864.742.22
263399-6339965.52366.06
359723-5972361.72362.23
462739-6273964.84065.37
562329-6232964.41764.94
663213-6321365.33065.85
20min166348-6634868.57070.462.0669.4271.332.06
268083-6808370.36371.26
366831-6683169.07069.92
469950-6995072.29373.18
569362-6936271.68572.57
668469-6846970.76271.65
30min173617-7361776.08377.292.2277.3278.562.22
275936-7593678.47979.77
371983-7198374.39475.63
476330-7633078.88780.18
575529-7552978.05979.34
675315-7531577.83879.12
45min179573-7957382.23882.701.8583.9084.391.84
280099-8009982.78284.51
378415-7841581.04282.69
482489-8248985.25286.98
578779-7877981.41883.13
680735-8073583.43985.15
60min180052-8005282.73385.922.2784.8588.082.25
284235-8423587.05689.24
381983-8198384.72986.82
484848-8484887.69089.89
582944-8294485.72287.89
684776-8477687.61689.79
极限184091-8409186.90888.572.3889.4891.202.36
285387-8538788.24790.92
382606-8260685.37387.94
487645-8764590.58193.27
587420-8742090.34892.99
687036-8703689.95192.61
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%
19.069805198056980889805498152980800.05
29.119910399214991580.08
单位质量响应值RSD%判断
10825.6110884.520.39数据可信
影响因素30天-供试品溶液-2024041311批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139971-3997141.34342.052.8041.3442.052.80
239637-3963740.99741.00
341844-4184443.28043.28
439751-3975141.11541.12
540429-4042941.81641.82
642286-4228643.73743.74
10min155870-5587057.78759.154.1358.0259.394.13
254779-5477956.65956.89
359041-5904161.06761.31
455476-5547657.38057.61
557054-5705459.01259.24
660924-6092463.01563.26
15min165210-6521067.44868.332.7968.0068.892.79
263862-6386266.05466.60
367737-6773770.06270.64
464380-6438066.58967.14
566879-6687969.17469.73
668313-6831370.65771.25
20min169706-6970672.09872.862.9173.0273.812.91
267625-6762569.94670.86
372191-7219174.66875.64
469214-6921471.58972.51
570706-7070673.13274.08
673243-7324375.75776.74
30min177266-7726679.91880.252.8381.2481.602.84
275739-7573978.33879.64
380100-8010082.84984.23
475109-7510977.68779.00
576947-7694779.58880.94
680362-8036283.12084.53
45min182080-8208084.89785.572.8386.6787.362.83
280056-8005682.80384.54
384652-8465287.55789.40
480140-8014082.89084.64
583921-8392186.80188.59
685541-8554188.47790.34
60min187238-8723890.23288.032.9492.4790.302.92
281999-8199984.81387.01
386546-8654689.51691.85
482548-8254885.38187.59
584432-8443287.32989.60
687907-8790790.92493.28
极限187750-8775090.76189.452.9993.5092.202.98
283463-8346386.32788.99
388212-8821291.23994.07
483804-8380486.68089.36
585729-8572988.67191.43
689913-8991392.99995.86
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%
19.069879499007988939890098797988780.09
29.111005341007701006520.17
单位质量响应值RSD%判断
10913.6911048.520.87数据可信
影响因素30天-供试品溶液-2024041311批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133556-3355634.31036.333.7334.3136.333.73
235321-3532136.11536.11
335545-3554536.34436.34
437187-3718738.02338.02
534804-3480435.58635.59
636776-3677637.60337.60
10min149740-4974050.85852.302.1851.0552.502.18
249731-4973150.84951.05
352066-5206653.23653.44
451534-5153452.69252.90
551823-5182352.98853.19
652024-5202453.19353.40
15min158471-5847159.78561.681.8560.2662.171.85
260118-6011861.46961.95
359840-5984061.18561.68
461439-6143962.82063.32
560705-6070562.06962.56
661362-6136262.74163.25
20min163662-6366265.09367.312.0165.9068.142.00
264898-6489866.35767.18
367131-6713168.64069.48
465953-6595367.43568.29
566644-6664468.14268.98
666685-6668568.18469.04
30min172380-7238074.00775.651.7475.1776.861.74
272498-7249874.12875.32
374275-7427575.94477.16
475158-7515876.84778.07
575378-7537877.07278.29
674227-7422775.89577.13
45min176164-7616477.87680.842.1879.4582.472.18
277962-7796279.71481.32
379989-7998981.78783.43
479849-7984981.64483.30
580945-8094582.76484.41
679478-7947881.26482.92
60min181016-8101682.83783.841.9784.8585.921.96
279800-7980081.59483.64
382546-8254684.40186.50
482299-8229984.14986.26
581697-8169783.53385.64
684595-8459586.49688.60
极限183075-8307584.94285.831.8587.4188.381.84
281631-8163183.46685.97
384321-8432186.21688.78
483464-8346485.34087.92
585845-8584587.77590.34
685334-8533487.25289.84
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