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%
117.401948591947941949061950131947961948740.05
217.411948411949871949140.06
单位质量响应值RSD%判断
11199.6611195.520.03数据可信
供试品溶液-2024122421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%
5min12997-29971.4981.477.711.501.477.52
23289-32891.6441.64
32613-26131.3061.31
42857-28571.4281.43
52855-28551.4271.43
63045-30451.5221.52
10min16126-61263.0623.073.693.083.083.73
26566-65663.2823.30
35940-59402.9692.98
46162-61623.0803.10
55975-59752.9863.00
66062-60623.0303.05
15min19412-94124.7044.573.314.764.633.36
29570-95704.7834.84
38847-88474.4224.47
48918-89184.4574.51
58911-89114.4544.50
69255-92554.6264.68
20min112597-125976.2966.263.416.406.363.41
213198-131986.5976.70
311998-119985.9976.09
412334-123346.1656.26
512231-122316.1136.21
612743-127436.3696.47
30min122097-2209711.04511.142.3511.2211.322.35
223268-2326811.63011.81
322432-2243211.21211.38
421925-2192510.95911.13
521819-2181910.90611.07
622235-2223511.11411.29
45min132030-3203016.01015.732.0416.3116.022.05
232433-3243316.21116.52
331458-3145815.72416.01
430871-3087115.43015.72
530994-3099415.49215.78
630994-3099415.49215.79
60min142895-4289521.44021.231.6121.9121.701.60
243256-4325621.62122.11
342371-4237121.17821.64
442823-4282321.40421.87
542138-4213821.06221.52
641343-4134320.66421.13
极限148707-4870724.34524.031.1825.0624.741.19
248684-4868424.33425.06
348315-4831524.14924.85
447430-4743023.70724.41
547755-4775523.86924.56
647565-4756523.77424.47
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%
117.401938031939001940501937951937921938680.06
217.411939781938441939110.05
单位质量响应值RSD%判断
11141.8411137.910.03数据可信
供试品溶液-2024122421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%
5min13046-30461.5301.562.831.531.562.85
23224-32241.6201.62
33137-31371.5761.58
43192-31921.6041.60
53012-30121.5131.51
63047-30471.5311.53
10min16648-66483.3403.411.693.363.421.67
26911-69113.4723.49
36891-68913.4623.48
46836-68363.4353.45
56674-66743.3533.37
66720-67203.3763.39
15min19799-97994.9235.072.244.985.122.20
210269-102695.1595.22
310011-100115.0305.09
410328-103285.1895.24
510246-102465.1485.20
69865-98654.9565.01
20min113175-131756.6196.632.486.736.742.45
213745-137456.9067.02
312775-127756.4186.53
413292-132926.6786.79
513159-131596.6116.72
612996-129966.5296.64
30min122339-2233911.22411.342.0911.4111.532.07
223218-2321811.66511.86
322783-2278311.44711.63
422882-2288211.49611.68
522299-2229911.20311.39
621920-2192011.01311.20
45min132240-3224016.19816.222.0316.5116.532.00
232651-3265116.40416.72
331638-3163815.89616.21
432875-3287516.51716.83
532911-3291116.53516.84
631365-3136515.75816.06
60min143839-4383922.02622.161.0722.5122.651.07
243992-4399222.10222.60
343507-4350721.85922.35
444676-4467622.44622.95
544652-4465222.43422.93
643914-4391422.06322.54
极限149080-4908024.65924.841.1225.3925.581.12
250021-5002125.13125.88
349172-4917224.70525.43
450021-5002125.13125.88
549717-4971724.97925.72
648691-4869124.46325.19
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%
117.401951301950361948101948541950751949810.08
217.411945821946861946340.04
单位质量响应值RSD%判断
11205.8011179.440.17数据可信
供试品溶液-12461045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%
5min13672-36721.8361.706.481.841.706.55
23266-32661.6331.63
33199-31991.6001.60
43219-32191.6101.61
53406-34061.7031.70
63681-36811.8411.84
10min16866-68663.4333.451.193.453.471.21
26997-69973.4993.52
36825-68253.4133.43
46845-68453.4233.44
56847-68473.4243.44
67007-70073.5043.52
15min19954-99544.9784.822.135.044.882.14
29793-97934.8974.95
39563-95634.7824.84
49376-93764.6884.74
59556-95564.7784.84
69574-95744.7874.85
20min112918-129186.4606.562.026.576.671.98
213414-134146.7086.82
313201-132016.6016.71
412760-127606.3816.49
513382-133826.6926.80
612986-129866.4946.61
30min124410-2441012.20612.130.9112.3912.310.91
224411-2441112.20712.39
324260-2426012.13112.31
423839-2383911.92112.10
524242-2424212.12212.31
624393-2439312.19812.38
45min133800-3380016.90216.711.6117.2217.021.60
234011-3401117.00717.33
333736-3373616.87017.19
432758-3275816.38116.69
533355-3335516.67917.00
632783-3278316.39316.71
60min143891-4389121.94821.771.4022.4622.281.39
244472-4447222.23822.75
343631-4363121.81822.32
443239-4323921.62222.12
543261-4326121.63322.14
642717-4271721.36121.86
极限149430-4943024.71824.211.4325.4724.961.40
248144-4814424.07424.83
348861-4886124.43325.18
448585-4858524.29525.03
548004-4800424.00424.75
647471-4747123.73824.48
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%
117.401949441951931949671950141948321949900.07
217.411949711947721948720.08
单位质量响应值RSD%判断
11206.3211193.110.09数据可信
供试品溶液-12461045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%
5min14193-41932.0951.947.072.101.947.17
23992-39921.9951.99
33562-35621.7801.78
44180-41802.0892.09
53770-37701.8841.88
63628-36281.8131.81
10min17950-79503.9733.893.234.003.913.28
28215-82154.1054.13
37667-76673.8313.85
47688-76883.8423.87
57529-75293.7623.78
67666-76663.8313.85
15min111256-112565.6255.463.435.695.533.42
211506-115065.7505.82
310705-107055.3505.41
410824-108245.4095.48
510823-108235.4095.47
610494-104945.2445.31
20min114046-140467.0196.991.337.157.121.36
214272-142727.1327.26
313802-138026.8977.02
414057-140577.0257.15
514034-140347.0137.14
613773-137736.8837.00
30min124338-2433812.16312.212.1112.3712.412.09
225278-2527812.63212.84
324825-2482512.40612.60
423964-2396411.97612.18
524217-2421712.10212.30
624001-2400111.99412.19
45min133472-3347216.72716.901.7717.0717.241.76
234864-3486417.42317.77
334059-3405917.02017.36
433572-3357216.77717.11
533801-3380116.89217.23
633147-3314716.56516.90
60min143483-4348321.73022.132.0622.2622.662.05
245449-4544922.71223.26
345344-4534422.66023.19
444119-4411922.04822.57
544039-4403922.00822.53
643318-4331821.64722.16
极限148735-4873524.35524.671.8125.1225.441.81
250774-5077425.37326.17
349722-4972224.84825.62
449782-4978224.87825.65
548476-4847624.22524.99
648649-4864924.31225.07
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