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%
19.179849198669987329898498774987300.19
29.169938099700995400.23
单位质量响应值RSD%判断
10766.6310866.810.66数据可信
长期36月-供试品溶液-20201213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%
5min167992-6799270.57672.934.1670.5872.934.15
273579-7357976.37576.37
374006-7400676.81876.82
466963-6696369.50769.51
569102-6910271.72871.73
669896-6989672.55272.55
10min186029-8602989.29890.224.0089.6990.634.00
291117-9111794.57995.00
391038-9103894.49794.92
483156-8315686.31686.70
586503-8650389.79090.19
683681-8368186.86187.26
15min189220-8922092.61095.554.4593.5096.454.44
296699-96699100.373101.32
397234-97234100.929101.88
487860-8786091.19992.06
592322-9232295.83096.73
688954-8895492.33493.22
20min191818-9181895.30797.363.9896.7198.803.98
298217-98217101.949103.46
398451-98451102.192103.70
489272-8927292.66494.04
593051-9305196.58798.02
691995-9199595.49196.89
30min191211-9121194.67796.265.5796.6198.235.53
292081-9208195.58097.65
3102917-102917106.828108.91
488642-8864292.01093.90
591881-9188195.37297.34
689656-8965693.06394.99
45min190152-9015293.57896.825.3196.0499.335.28
297493-97493101.198103.80
3101242-101242105.089107.76
488888-8888892.26694.66
591720-9172095.20597.70
690164-9016493.59096.04
60min191155-9115594.61996.085.2197.6099.135.18
296196-9619699.851103.02
399948-99948103.746107.00
486233-8623389.51092.42
591604-9160495.08598.11
690212-9021293.64096.61
极限190535-9053593.97594.964.8097.4898.544.79
294541-9454198.133101.86
398718-98718102.469106.30
486955-8695590.25993.67
589961-8996193.37996.93
688181-8818191.53295.02
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%
19.179931998967991569916998750990720.23
29.169907898969990240.08
单位质量响应值RSD%判断
10803.9310810.480.05数据可信
长期36月-供试品溶液-20201214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%
5min166457-6645769.04268.995.4369.0468.995.43
269298-6929871.99371.99
369064-6906471.75071.75
466998-6699869.60469.60
559444-5944461.75661.76
667205-6720569.81969.82
10min184160-8416087.43389.112.3987.8289.492.39
289770-8977093.26193.66
384994-8499488.29988.70
485871-8587189.21189.60
584619-8461987.91088.25
685208-8520888.52288.91
15min191243-9124394.79195.081.6495.6695.961.65
294429-9442998.10199.02
391065-9106594.60795.50
491553-9155395.11496.00
590188-9018893.69594.53
690661-9066194.18795.07
20min193807-9380797.45597.661.7398.8599.071.73
296812-96812100.577102.04
393534-9353497.17298.59
494797-9479798.48499.89
592642-9264296.24597.60
692435-9243596.03097.43
30min193836-9383697.48598.681.5299.42100.631.53
297420-97420101.209103.23
394471-9447198.145100.10
496055-9605599.791101.75
594111-9411197.77199.66
694014-9401497.67099.61
45min194096-9409697.75599.151.69100.23101.651.70
298274-98274102.096104.68
394386-9438698.057100.56
496196-9619699.937102.45
594222-9422297.886100.32
695454-9545499.166101.65
60min192741-9274196.34897.201.4799.37100.251.48
295720-9572099.443102.59
392621-9262196.22399.27
494849-9484998.538101.61
592470-9247096.06699.04
692952-9295296.56799.60
极限192482-9248296.07997.231.4899.64100.821.49
295854-9585499.582103.29
393790-9379097.438101.02
494208-9420897.872101.49
591992-9199295.57099.08
693212-9321296.837100.40
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%
19.179963199446995419965299285995110.16
29.169911898866989920.19
单位质量响应值RSD%判断
10851.8010806.990.30数据可信
长期36月-供试品溶液-20201215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%
5min168520-6852071.03970.301.4771.0470.301.47
267278-6727869.75269.75
367522-6752270.00570.00
469311-6931171.85971.86
566475-6647568.91968.92
667763-6776370.25470.25
10min185778-8577888.93289.540.5989.3389.930.59
286320-8632089.49489.88
386947-8694790.14490.53
486997-8699790.19690.59
585945-8594589.10589.49
686194-8619489.36389.75
15min192257-9225795.64995.381.1296.5496.271.10
290870-9087094.21195.10
393442-9344296.87897.77
491074-9107494.42295.32
592834-9283496.24797.13
691500-9150094.86495.75
20min194713-9471398.19598.770.8999.62100.190.88
294240-9424097.70599.11
395921-9592199.448100.88
495021-9502198.51599.94
596562-96562100.112101.52
695144-9514498.642100.06
30min194928-9492898.41899.921.03100.38101.891.02
297061-97061100.630102.58
397503-97503101.088103.07
496280-9628099.820101.79
596962-96962100.527102.50
695536-9553699.048101.01
45min195775-9577599.29699.111.68101.81101.641.65
294243-9424397.708100.22
397540-97540101.126103.67
493421-9342196.85699.38
597172-97172100.745103.27
695439-9543998.948101.46
60min194474-9447497.94798.511.85101.01101.581.81
293336-9333696.76899.82
397387-97387100.968104.07
493628-9362897.070100.14
597028-97028100.595103.68
694222-9422297.686100.75
极限193591-9359197.03297.171.13100.64100.791.11
291953-9195395.33498.92
394767-9476798.251101.92
493715-9371597.161100.76
594826-9482698.312101.96
693489-9348996.926100.53
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