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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 18.102020032012402025882019332024452020420.27
2 18.032022262007772015020.51
单位质量响应值RSD%判断
11162.5411175.930.09数据可信
加速6月-供试品溶液-12521472批-磷酸盐溶液(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%
5min15581-55812.7972.995.242.802.995.23
25745-57452.8792.88
36220-62203.1173.12
45857-58572.9352.93
56425-64253.2203.22
65923-59232.9682.97
10min18875-88754.4474.617.954.484.647.91
28825-88254.4224.45
310670-106705.3475.38
48884-88844.4524.48
59117-91174.5694.60
68805-88054.4124.45
15min112580-125806.3046.141.906.386.221.85
211890-118905.9586.04
312394-123946.2116.30
412239-122396.1336.22
512155-121556.0916.18
612239-122396.1336.21
20min115272-152727.6537.722.087.807.882.08
215094-150947.5647.71
315604-156047.8197.98
415957-159577.9968.15
515349-153497.6917.85
615178-151787.6067.76
30min122717-2271711.38311.482.6311.6211.722.62
222358-2235811.20411.43
323441-2344111.74612.00
423857-2385711.95512.19
522556-2255611.30311.54
622507-2250711.27811.51
45min135224-3522417.65117.673.3818.0118.043.33
234344-3434417.21017.57
335458-3545817.76818.15
437500-3750018.79119.16
534310-3431017.19317.56
634728-3472817.40217.76
60min146927-4692723.51523.433.0224.0723.992.99
246212-4621223.15723.70
346683-4668323.39323.97
449389-4938924.74925.33
545306-4530622.70323.26
646015-4601523.05823.61
极限153901-5390127.01026.743.6727.8327.563.62
251927-5192726.02026.82
353213-5321326.66527.50
456871-5687128.49829.35
551308-5130825.71026.52
652942-5294226.52927.34
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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 18.102023692013482023122022052020022020470.21
2 18.032018702016812017760.07
单位质量响应值RSD%判断
11162.8211191.130.18数据可信
长期6月-供试品溶液-12521472批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14768-47682.3882.316.402.392.316.38
24117-41172.0622.06
34674-46742.3412.34
44409-44092.2082.21
54856-48562.4322.43
64860-48602.4342.43
10min18976-89764.4954.521.194.524.541.19
28894-88944.4544.48
38969-89694.4914.52
48968-89684.4914.52
59152-91524.5834.61
69149-91494.5814.61
15min113029-130296.5246.481.616.606.561.64
212654-126546.3376.41
312753-127536.3866.46
412897-128976.4586.53
513178-131786.5996.68
613123-131236.5716.65
20min117231-172318.6288.611.498.788.761.47
216820-168208.4238.57
317139-171398.5828.73
417126-171268.5768.72
517302-173028.6648.82
617601-176018.8148.96
30min124717-2471712.37712.510.8012.6212.760.77
225256-2525612.64712.88
324792-2479212.41512.66
425100-2510012.56912.81
525003-2500312.52012.77
625035-2503512.53612.79
45min135938-3593817.99618.080.8218.3818.460.81
236310-3631018.18218.56
336365-3636518.21018.59
435592-3559217.82318.20
536215-3621518.13518.52
636233-3623318.14418.53
60min146227-4622723.14823.140.5523.7323.720.55
246345-4634523.20723.79
346422-4642223.24623.83
445770-4577022.91923.50
546062-4606223.06623.65
646410-4641023.24023.83
极限151971-5197126.02525.770.9226.8626.600.89
251714-5171425.89626.73
351412-5141225.74526.59
450640-5064025.35826.19
551273-5127325.67526.52
651714-5171425.89626.74
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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 18.102021322021902017732015092014092018030.18
2 18.032002262015002008630.45
单位质量响应值RSD%判断
11149.3411140.490.06数据可信
中间条件6月-供试品溶液-12521472批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14928-49282.4752.394.412.472.394.39
24818-48182.4202.42
34906-49062.4642.46
44367-43672.1932.19
54864-48642.4432.44
64719-47192.3702.37
10min17806-78063.9203.952.073.953.982.07
27780-77803.9073.93
38064-80644.0504.08
47648-76483.8413.87
58049-80494.0424.07
67848-78483.9413.97
15min111519-115195.7855.811.545.865.881.58
211533-115335.7925.86
311739-117395.8955.97
411258-112585.6545.72
511737-117375.8945.97
611584-115845.8175.89
20min116828-168288.4518.391.348.598.531.33
216475-164758.2748.41
316817-168178.4458.58
416382-163828.2278.36
516897-168978.4868.62
616872-168728.4738.61
30min123982-2398212.04411.950.7212.2712.180.70
223525-2352511.81412.04
323840-2384011.97212.20
423919-2391912.01212.23
523834-2383411.96912.20
623665-2366511.88412.11
45min135402-3540217.77917.641.2618.1418.001.25
234651-3465117.40117.76
335714-3571417.93518.30
434571-3457117.36117.72
535221-3522117.68818.05
635227-3522717.69118.05
60min145966-4596623.08422.821.1823.6423.371.15
245310-4531022.75423.31
344566-4456622.38122.94
445614-4561422.90723.45
545964-4596423.08323.64
645175-4517522.68623.24
极限151574-5157425.90026.191.6226.7227.001.57
250792-5079225.50726.31
352432-5243226.33127.14
452987-5298726.61027.41
552912-5291226.57227.39
652166-5216626.19727.01
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