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%
118.102073182069932068772066572068672069420.12
218.032060972060422060700.02
单位质量响应值RSD%判断
11433.2611429.280.03数据可信
加速6月-供试品溶液-2025010321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%
5min13733-37331.8281.8930.081.831.9030.08
22668-26681.3061.31
35935-59352.9062.91
43188-31881.5611.56
53307-33071.6191.62
64374-43742.1422.14
10min18759-87594.2894.3412.104.314.3612.14
27784-77843.8113.83
310907-109075.3405.37
48290-82904.0594.08
58588-85884.2054.22
68903-89034.3594.38
15min111482-114825.6225.9310.505.696.0010.54
211035-110355.4035.46
314606-146067.1517.24
411588-115885.6745.74
511995-119955.8735.94
611977-119775.8645.94
20min117798-177988.7149.067.438.849.207.50
217361-173618.5008.62
321222-2122210.39110.56
418199-181998.9109.04
518214-182148.9189.05
618259-182598.9409.08
30min123396-2339611.45511.734.4211.6811.974.52
223253-2325311.38511.60
326075-2607512.76713.05
423797-2379711.65111.88
523827-2382711.66611.90
623445-2344511.47911.72
45min137264-3726418.24518.473.0518.6018.843.14
236862-3686218.04818.39
339999-3999919.58420.01
437529-3752918.37518.73
537650-3765018.43418.79
637072-3707218.15118.52
60min147360-4736023.18823.201.4823.7523.781.58
246493-4649322.76323.30
348501-4850123.74724.39
447514-4751423.26323.82
547658-4765823.33423.90
646830-4683022.92823.49
极限152162-5216225.53925.662.3426.3526.492.39
251495-5149525.21326.00
354239-5423926.55627.47
452914-5291425.90726.72
552914-5291425.90726.73
650755-5075524.85025.67
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%
118.102064332066742063452061832060922063450.12
218.032055622057232056420.06
单位质量响应值RSD%判断
11400.2811405.550.04数据可信
长期6月-供试品溶液-2025010321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%
5min13813-38131.8722.2128.251.872.2128.27
24038-40381.9821.98
33945-39451.9361.94
45811-58112.8522.85
53081-30811.5121.51
66334-63343.1093.11
10min17490-74903.6764.2212.723.704.2512.78
27662-76623.7613.78
37941-79413.8983.92
49796-97964.8084.84
58745-87454.2924.31
610012-100124.9144.95
15min114856-148567.2927.489.637.357.559.68
214426-144267.0817.14
314670-146707.2007.27
416789-167898.2418.33
513434-134346.5946.66
617227-172278.4568.54
20min117649-176498.6639.207.798.819.367.85
218304-183048.9849.13
318328-183288.9969.14
420331-203319.97910.16
517109-171098.3988.54
620716-2071610.16810.35
30min122923-2292311.25111.875.8811.4912.135.98
223485-2348511.52711.77
324324-2432411.93912.18
425640-2564012.58512.87
522676-2267611.13011.36
626081-2608112.80113.10
45min136053-3605317.69618.413.7218.0618.803.82
236328-3632817.83118.20
337729-3772918.51818.90
439185-3918519.23319.66
536602-3660217.96518.32
639095-3909519.18919.63
60min147820-4782023.47124.382.1524.0324.972.15
250142-5014224.61125.18
349730-4973024.40924.99
449148-4914824.12324.76
550372-5037224.72425.28
650789-5078924.92925.58
极限151830-5183025.44026.552.4326.2627.412.49
254237-5423726.62127.46
354322-5432226.66327.52
454891-5489126.94227.85
553556-5355626.28727.12
655667-5566727.32328.25
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%
118.102062982068272066272064752065052065460.10
218.032050052051132050590.04
单位质量响应值RSD%判断
11411.3811373.210.24数据可信
中间条件6月-供试品溶液-2025010321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%
5min12830-28301.3901.465.161.391.465.16
22729-27291.3411.34
33042-30421.4941.49
42989-29891.4681.47
53128-31281.5371.54
63063-30631.5051.50
10min17489-74893.6793.731.273.693.751.29
27518-75183.6933.71
37549-75493.7093.73
47693-76933.7793.80
57599-75993.7333.75
67727-77273.7963.81
15min110349-103495.0845.031.565.145.081.52
210209-102095.0165.07
310247-102475.0345.09
410096-100964.9605.02
510029-100294.9274.99
610461-104615.1395.20
20min114999-149997.3697.291.467.487.401.43
214735-147357.2397.35
315012-150127.3757.49
414820-148207.2817.39
514458-144587.1037.22
614988-149887.3637.48
30min125580-2558012.56712.212.1112.7612.402.09
225002-2500212.28312.48
325000-2500012.28212.48
424283-2428311.93012.12
524194-2419411.88612.08
625033-2503312.29812.50
45min133122-3312216.27216.171.9016.6116.501.88
232993-3299316.20916.54
333340-3334016.38016.71
432324-3232415.88016.21
532031-3203115.73616.06
633681-3368116.54716.88
60min144764-4476421.99221.641.8222.5122.151.82
244321-4432121.77422.28
344068-4406821.65022.16
443233-4323321.24021.74
542996-4299621.12321.62
644957-4495722.08722.61
极限150160-5016024.64324.631.8825.4025.381.85
249792-4979224.46225.21
350895-5089525.00425.76
448567-4856723.86024.60
550088-5008824.60825.34
651251-5125125.17925.94
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