阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.959945999451993729925499264993600.10
210.009929699342993190.04
单位质量响应值RSD%判断
9985.939931.900.39数据可信
加速6月-供试品溶液-2023111721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%
5min160239-6023954.27652.368.3554.2852.368.35
264054-6405457.71357.71
359196-5919653.33653.34
449468-4946844.57144.57
556899-5689951.26651.27
658821-5882152.99853.00
10min174879-7487967.46769.356.6567.7769.646.64
279497-7949771.62771.95
378849-7884971.04471.34
467561-6756160.87361.12
581657-8165773.57473.86
679382-7938271.52471.82
15min185699-8569977.21678.444.3377.8979.124.32
284897-8489776.49377.21
387478-8747878.81879.51
482242-8224274.10174.69
593204-9320483.97884.67
688833-8883380.03980.73
20min198516-9851688.76485.033.6289.8786.153.59
289811-8981180.92082.06
392634-9263483.46484.59
492226-9222683.09684.09
597807-9780788.12589.29
695271-9527185.84086.98
30min1106272-10627295.75290.923.9797.3592.513.90
295420-9542085.97487.57
398998-9899889.19890.79
4102306-10230692.17993.64
5103996-10399693.70195.35
698484-9848488.73590.35
45min1107323-10732396.69992.932.3898.8395.022.34
2101348-10134891.31593.39
3102550-10255092.39894.49
4103726-10372693.45895.43
5103663-10366393.40195.57
6100242-10024290.31992.43
60min1104725-10472594.35891.912.6997.0394.522.65
2101340-10134091.30893.89
398948-9894889.15391.75
4102632-10263292.47294.96
5105355-10535594.92697.61
699062-9906289.25691.86
极限1100626-10062690.66593.331.5793.8696.441.47
2105048-10504894.64997.73
3103534-10353493.28596.38
4104165-10416593.85496.86
5103207-10320792.99096.21
6104894-10489494.51097.61
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.959938999283991499924999187992510.10
210.009861398880987460.20
单位质量响应值RSD%判断
9974.979874.600.72数据可信
加速6月-供试品溶液-2023111821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%
5min160887-6088755.04950.117.7555.0550.117.75
250620-5062045.76745.77
352115-5211547.11847.12
460168-6016854.39954.40
555713-5571350.37150.37
653048-5304847.96247.96
10min187724-8772479.31371.898.4279.6272.178.39
284036-8403675.97976.23
382570-8257074.65374.92
479359-7935971.75072.05
570229-7022963.49663.78
673143-7314366.13066.40
15min191998-9199883.17881.954.1683.9282.634.16
294586-9458685.51786.19
390827-9082782.11982.80
494174-9417485.14585.85
585863-8586377.63178.26
686391-8639178.10878.74
20min198347-9834788.91889.165.2990.1390.305.27
2103401-10340193.48794.64
398779-9877989.30890.44
4103543-10354393.61694.79
598444-9844489.00590.07
689199-8919980.64781.71
30min1104734-10473494.69291.582.6896.3993.212.69
299895-9989590.31791.99
3103220-10322093.32494.95
4102304-10230492.49594.19
5100490-10049090.85592.41
697116-9711687.80589.32
45min1107842-10784297.50293.213.6199.7395.353.60
2100096-10009690.49992.67
3104213-10421394.22196.37
4105016-10501694.94797.16
5103951-10395193.98496.05
697439-9743988.09790.10
60min1106716-10671696.48493.583.3799.2596.243.36
2102831-10283192.97295.65
3103296-10329693.39296.06
4108115-10811597.749100.48
598507-9850789.06291.65
6101570-10157091.83294.32
极限1107751-10775197.42093.663.25100.7396.833.18
298794-9879489.32292.51
3103935-10393593.97097.16
4104575-10457594.54997.83
5100498-10049890.86393.94
6105968-10596895.80898.81
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.959968599666996199959899454996040.10
210.009901299118990650.08
单位质量响应值RSD%判断
10010.459906.500.74数据可信
加速6月-供试品溶液-2023111921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%
5min150607-5060745.60047.368.2345.6047.368.23
253900-5390048.56748.57
356828-5682851.20651.21
448401-4840143.61243.61
547701-4770142.98242.98
657908-5790852.17952.18
10min188134-8813479.41576.393.5279.6776.653.52
284446-8444676.09176.36
383943-8394375.63875.92
480995-8099572.98273.22
582669-8266974.49074.73
688451-8845179.70079.99
15min193186-9318683.96781.293.3584.6681.983.34
287476-8747678.82279.51
388168-8816879.44580.15
488560-8856079.79880.45
589130-8913080.31280.96
694802-9480285.42386.16
20min196114-9611486.60584.513.9387.7785.653.91
292181-9218183.06184.19
397448-9744887.80788.95
491985-9198582.88583.98
588049-8804979.33880.44
696953-9695387.36188.57
30min199134-9913489.32689.922.4790.9791.522.42
2100658-10065890.70092.29
3103779-10377993.51295.15
498362-9836288.63190.18
5100319-10031990.39491.93
696486-9648686.94088.63
45min1104132-10413293.83093.671.6695.9795.781.66
2102164-10216492.05794.15
3106911-10691196.33498.49
4104262-10426293.94795.99
5102311-10231192.18994.23
6103976-10397693.68995.86
60min1103379-10337993.15192.522.4095.8195.152.32
2102814-10281492.64295.25
3100469-10046990.52993.22
499453-9945389.61492.18
5106361-10636195.83898.39
6103598-10359893.34996.04
极限1102689-10268992.53092.342.0595.7195.482.00
2100819-10081990.84593.97
3100225-10022590.30993.50
4103483-10348393.24596.31
5101662-10166291.60494.69
6105999-10599995.51298.73
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.959805097990978659794598024979750.08
210.001005701004821005260.07
单位质量响应值RSD%判断
9846.7310052.601.47数据可信
加速6月-供试品溶液批-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%
5min129972-2997227.03326.6811.8627.0326.6811.86
232793-3279329.57729.58
327098-2709824.44124.44
424223-2422321.84821.85
533596-3359630.30130.30
629826-2982626.90126.90
10min160540-6054054.60352.965.4354.7553.115.44
262355-6235556.24056.40
353465-5346548.22248.36
456554-5655451.00851.13
559715-5971553.85954.03
659707-5970753.85254.00
15min180428-8042872.54166.595.8572.9967.045.84
273117-7311765.94766.42
367674-6767461.03861.44
472933-7293365.78166.19
576626-7662669.11269.58
672229-7222965.14665.59
20min197379-9737987.83083.034.5788.6983.844.57
294609-9460985.33186.17
387127-8712778.58379.33
489913-8991381.09681.87
595137-9513785.80786.66
688171-8817179.52580.34
30min1103565-10356593.40988.386.3894.7589.666.35
2101442-10144291.49492.81
387898-8789879.27880.46
4100958-10095891.05892.28
5101515-10151591.56092.89
692574-9257483.49684.75
45min1107036-10703696.54091.195.3398.4092.955.29
2103607-10360793.44795.27
398514-9851488.85390.47
4102843-10284392.75894.48
5102997-10299792.89794.73
691615-9161582.63184.35
60min1103321-10332193.18993.921.2295.5996.191.22
2103371-10337193.23495.58
3103568-10356893.41295.53
4105118-10511894.81097.05
5106256-10625695.83698.19
6103166-10316693.04995.22
极限1101436-10143691.48992.181.3194.4194.981.28
2101097-10109791.18394.05
3101171-10117191.25093.88
4104554-10455494.30197.07
5102921-10292192.82895.71
6102051-10205192.04394.74
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