美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.202060272054722057932048102046172053440.30
218.192065442073512069480.28
单位质量响应值RSD%判断
11282.6411377.020.59数据可信
长期24月-供试品溶液-2023082421批-pH7.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15801-58012.6832.623.792.682.623.68
25997-59972.7742.77
35511-55112.5492.55
45504-55042.5462.55
55442-54422.5172.52
65705-57052.6392.64
10min18881-88814.1084.173.154.144.203.18
29553-95534.4184.45
38938-89384.1344.16
48723-87234.0354.06
58943-89434.1364.16
69042-90424.1824.21
15min113539-135396.2626.262.536.346.342.57
213967-139676.4606.54
313464-134646.2276.30
412976-129766.0026.07
513477-134776.2336.31
613818-138186.3916.47
20min116530-165307.6457.592.117.797.742.11
216851-168517.7947.95
316250-162507.5167.66
415864-158647.3377.48
516317-163177.5477.69
616639-166397.6967.84
30min127764-2776412.84112.692.0413.0712.922.04
228364-2836413.11913.36
326963-2696312.47112.70
427266-2726612.61112.83
526858-2685812.42212.65
627422-2742212.68312.92
45min136317-3631716.79716.771.1417.1717.141.13
236035-3603516.66717.05
336734-3673416.99017.36
435825-3582516.57016.93
535883-3588316.59616.96
636752-3675216.99817.37
60min148749-4874922.54722.241.1523.1122.801.13
247744-4774422.08222.65
347765-4776522.09222.65
447351-4735121.90122.45
548315-4831522.34622.90
648590-4859022.47423.04
极限153026-5302624.52525.143.8425.3425.953.70
253844-5384424.90425.72
358450-5845027.03427.83
453797-5379724.88225.67
552754-5275424.39925.20
654290-5429025.11025.92
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.202065582073792064062063492066632066710.21
218.192033662030232031940.12
单位质量响应值RSD%判断
11355.5511170.641.17数据可信
长期24月-供试品溶液-2023082521批-pH7.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16507-65073.0282.893.543.032.893.51
26012-60122.7972.80
35907-59072.7482.75
46266-62662.9152.92
56279-62792.9212.92
66327-63272.9442.94
10min19988-99884.6474.482.014.684.512.01
29579-95794.4574.49
39603-96034.4684.50
49531-95314.4354.47
59619-96194.4764.51
69416-94164.3814.41
15min114536-145366.7636.543.136.856.623.11
214595-145956.7916.87
313738-137386.3926.47
413562-135626.3106.39
514125-141256.5726.65
613756-137566.4006.48
20min117561-175618.1717.892.398.338.042.37
216741-167417.7897.95
316466-164667.6617.81
416662-166627.7527.90
517123-171237.9678.12
617177-171777.9928.14
30min129303-2930313.63413.242.2913.8913.482.29
228658-2865813.33413.58
327343-2734312.72212.96
428404-2840413.21613.45
528723-2872313.36413.61
628260-2826013.14913.39
45min138825-3882518.06417.272.5318.4717.662.52
236356-3635616.91617.31
336849-3684917.14517.52
437030-3703017.22917.61
537363-3736317.38417.78
636250-3625016.86617.25
60min151242-5124223.84223.442.1324.4524.032.11
252037-5203724.21224.79
349334-4933422.95423.52
449353-4935322.96323.54
550258-5025823.38423.97
650106-5010623.31323.89
极限157789-5778926.88825.712.5427.7626.552.51
254474-5447425.34626.19
354776-5477625.48626.31
455807-5580725.96626.80
554824-5482425.50826.35
653827-5382725.04525.88
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.202034612029952028712028722029102030220.13
218.192034222035582034900.05
单位质量响应值RSD%判断
11155.0511186.920.21数据可信
长期24月-供试品溶液-2023082621批-pH7.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15225-52252.4512.523.562.452.523.62
25644-56442.6482.65
35206-52062.4422.44
45248-52482.4622.46
55565-55652.6102.61
65290-52902.4812.48
10min18105-81053.8023.963.243.833.993.19
28643-86434.0544.08
38086-80863.7933.82
48564-85644.0174.04
58572-85724.0214.05
68687-86874.0754.10
15min112766-127665.9886.062.326.066.132.29
213083-130836.1376.21
312403-124035.8185.89
412880-128806.0426.11
513236-132366.2096.28
613082-130826.1376.21
20min115940-159407.4777.382.247.617.522.25
215812-158127.4177.56
315113-151137.0897.22
415757-157577.3917.53
516147-161477.5747.72
615626-156267.3307.47
30min125212-2521211.82711.661.6412.0511.891.66
225115-2511511.78112.01
324330-2433011.41311.63
424689-2468911.58111.80
525323-2532311.87912.11
624520-2452011.50211.72
45min135620-3562016.70916.512.5517.0616.862.55
235449-3544916.62916.98
333649-3364915.78416.12
435159-3515916.49316.84
536341-3634117.04717.41
634929-3492916.38516.73
60min146397-4639721.76422.181.6822.3022.711.64
246401-4640121.76622.31
347304-4730422.19022.70
447296-4729622.18622.72
547921-4792122.47923.03
648359-4835922.68423.22
极限154346-5434625.49325.291.0126.2726.070.99
253336-5333625.01925.80
354061-5406125.35926.12
453696-5369625.18825.97
554692-5469225.65526.45
653396-5339625.04725.83
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