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%
118.102057522059802060442060452058582059360.07
2 18.032056912060532058720.13
单位质量响应值RSD%判断
11377.6811418.300.26数据可信
加速6月-供试品溶液-2025010621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%
5min14971-49712.4412.616.662.442.616.70
24767-47672.3412.34
35560-55602.7302.73
45556-55562.7282.73
55595-55952.7472.75
65416-54162.6592.66
10min18010-80103.9334.001.493.964.031.54
28116-81163.9854.01
38164-81644.0094.04
48362-83624.1064.14
58064-80643.9603.99
68128-81283.9914.02
15min110606-106065.2085.322.625.285.392.63
210541-105415.1765.25
310838-108385.3225.40
411345-113455.5715.65
510791-107915.2995.37
610847-108475.3265.40
20min114128-141286.9377.043.757.077.183.64
215283-152837.5057.63
314108-141086.9287.06
414683-146837.2107.35
514015-140156.8827.02
613856-138566.8046.94
30min119887-198879.7659.872.069.9710.082.05
219771-197719.7089.92
320236-202369.93710.15
420843-2084310.23510.45
520091-200919.86610.08
619744-197449.6959.90
45min131274-3127415.35715.594.3515.6715.924.28
231131-3113115.28715.61
334363-3436316.87417.20
432187-3218715.80516.14
530710-3071015.08015.40
630854-3085415.15115.47
60min141301-4130120.28120.481.2920.7720.971.29
241336-4133620.29820.79
341877-4187720.56321.07
442590-4259020.91321.42
541946-4194620.59721.08
641183-4118320.22320.71
极限147088-4708823.12223.081.3423.8323.801.32
247048-4704823.10323.82
346532-4653222.84923.59
448131-4813123.63424.37
546339-4633922.75423.47
646827-4682722.99423.70
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%
118.102059952062842063262065092060542062340.11
2 18.032057372059072058220.06
单位质量响应值RSD%判断
11394.1411415.530.14数据可信
长期6月-供试品溶液-2025010621批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15846-58462.8692.8114.522.872.8114.51
24809-48092.3602.36
34562-45622.2392.24
46445-64453.1633.16
56376-63763.1293.13
66272-62723.0783.08
10min18854-88544.3454.349.324.384.379.32
27743-77433.8003.83
37941-79413.8973.92
49593-95934.7084.74
59468-94684.6464.68
69492-94924.6584.69
15min113000-130006.3806.396.196.466.476.24
211996-119965.8875.96
312093-120935.9356.00
413682-136826.7146.80
513718-137186.7326.82
613666-136666.7076.79
20min117548-175488.6128.644.808.768.794.87
216574-165748.1348.27
316636-166368.1648.30
418591-185919.1239.29
518258-182588.9609.12
618014-180148.8409.00
30min124955-2495512.24712.403.8712.4912.643.93
223908-2390811.73311.96
324488-2448812.01712.24
426417-2641712.96413.23
526086-2608612.80213.06
625745-2574512.63412.89
45min136663-3666317.99218.212.2818.3818.602.34
235725-3572517.53217.89
336886-3688618.10218.46
437898-3789818.59819.01
537767-3776718.53418.94
637701-3770118.50218.90
60min146658-4665822.89723.191.6323.4823.771.66
246005-4600522.57723.13
347893-4789323.50324.06
447751-4775123.43424.05
547879-4787923.49624.11
647295-4729523.21023.81
极限153059-5305926.03926.201.4626.8827.041.50
252752-5275225.88826.69
352837-5283725.93026.75
454528-5452826.75927.63
554200-5420026.59827.47
652890-5289025.95626.82
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%
118.102060052063912064382065632063842063560.11
2 18.032056502048462052480.28
单位质量响应值RSD%判断
11400.8811383.690.11数据可信
中间条件6月-供试品溶液-2025010621批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15004-50042.4582.0414.302.462.0414.36
23238-32381.5911.59
34134-41342.0312.03
44061-40611.9952.00
53917-39171.9241.92
64516-45162.2192.22
10min18349-83494.1023.873.534.133.903.55
27662-76623.7643.78
37639-76393.7533.78
47687-76873.7773.80
58023-80233.9423.96
67922-79223.8923.92
15min111657-116575.7275.521.985.805.582.02
211068-110685.4385.50
311187-111875.4965.56
411062-110625.4355.50
511266-112665.5355.60
611148-111485.4775.54
20min116435-164358.0747.503.908.217.633.89
215127-151277.4327.55
314839-148397.2907.42
414832-148327.2877.41
515248-152487.4917.62
615146-151467.4417.57
30min122697-2269711.15111.110.8811.3811.330.89
222668-2266811.13611.34
322699-2269911.15211.36
422300-2230010.95611.16
522875-2287511.23811.45
622500-2250011.05411.27
45min132951-3295116.18816.502.0916.5416.842.03
234846-3484617.11917.45
333648-3364816.53116.86
432940-3294016.18316.51
533430-3343016.42416.76
633752-3375216.58216.92
60min145143-4514322.17822.381.1422.7122.901.10
246505-4650522.84723.36
345258-4525822.23522.75
445593-4559322.39922.91
545661-4566122.43322.95
645153-4515322.18322.70
极限149984-4998424.55625.392.0825.3326.162.02
252975-5297526.02626.80
351917-5191725.50626.27
452379-5237925.73326.49
551964-5196425.52926.30
650917-5091725.01525.78
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