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%
118.152100982100732104922100322101782101750.09
218.172102562101012101780.06
单位质量响应值RSD%判断
11579.8911567.310.08数据可信
供试品溶液-12564941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%
5min13848-38481.8611.784.021.861.783.95
23720-37201.7991.80
33828-38281.8511.85
43623-36231.7521.75
53668-36681.7741.77
63445-34451.6661.67
10min16753-67533.2663.362.253.293.382.16
26998-69983.3843.40
37204-72043.4843.50
46952-69523.3623.38
56926-69263.3493.37
66825-68253.3013.32
15min110672-106725.1615.252.115.225.302.10
210820-108205.2325.29
311291-112915.4605.52
410822-108225.2335.29
510802-108025.2245.28
610675-106755.1625.22
20min114491-144917.0087.032.287.127.142.27
214980-149807.2447.36
314873-148737.1927.31
414383-143836.9557.07
514134-141346.8356.95
614312-143126.9217.03
30min124397-2439711.79811.612.8911.9911.802.88
224430-2443011.81412.01
324972-2497212.07612.28
423587-2358711.40611.60
523503-2350311.36611.56
623164-2316411.20211.39
45min137416-3741618.09417.951.6118.4218.271.60
237312-3731218.04418.37
337562-3756218.16518.50
437208-3720817.99318.31
537246-3724618.01218.33
635922-3592217.37217.69
60min146423-4642322.45022.771.9622.9723.291.94
247990-4799023.20723.74
347453-4745322.94823.48
448227-4822723.32223.84
546339-4633922.40922.93
646094-4609422.29122.80
极限150567-5056724.45424.843.2125.2325.623.10
248564-4856423.48524.27
351386-5138624.85025.64
453209-5320925.73126.51
552480-5248025.37926.15
652039-5203925.16625.92
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%
118.152080772082072083202078182077422080330.12
218.172097062094282095670.10
单位质量响应值RSD%判断
11461.8711533.680.45数据可信
供试品溶液-12564941批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12327-23271.1331.137.331.131.147.09
22596-25961.2641.26
32273-22731.1061.11
42362-23621.1501.15
52360-23601.1491.15
62066-20661.0061.01
10min12635-26351.2831.314.561.301.334.41
22908-29081.4161.43
32625-26251.2781.29
42573-25731.2521.27
52681-26811.3051.32
62776-27761.3511.36
15min12872-28721.3981.464.351.421.494.33
23206-32061.5611.59
32855-28551.3901.42
43045-30451.4821.51
52989-29891.4551.48
63057-30571.4881.51
20min13227-32271.5711.643.951.611.684.03
23553-35531.7301.78
33408-34081.6591.70
43200-32001.5581.60
53401-34011.6561.70
63424-34241.6671.71
30min13649-36491.7761.834.081.841.894.02
23922-39221.9091.98
33638-36381.7711.83
43768-37681.8341.89
53941-39411.9181.98
63583-35831.7441.81
45min14587-45872.2332.292.912.312.372.90
24660-46602.2682.36
34525-45252.2032.28
44728-47282.3022.38
54902-49022.3862.47
64785-47852.3292.41
60min15402-54022.6302.703.432.732.813.38
25841-58412.8432.96
35686-56862.7682.87
45561-55612.7072.81
55315-53152.5872.70
65519-55192.6872.79
极限16155-61552.9963.061.763.133.201.81
26440-64403.1353.28
36211-62113.0233.16
46253-62533.0443.18
56238-62383.0373.17
66390-63903.1113.25
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%
118.152106982105462104332105602105412105560.05
218.172107082104332105700.10
单位质量响应值RSD%判断
11600.8811588.880.08数据可信
供试品溶液-12564941批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1830-8300.4010.445.780.400.445.67
2888-8880.4290.43
3970-9700.4680.47
4908-9080.4380.44
5884-8840.4270.43
6963-9630.4650.46
10min11156-11560.5580.567.450.560.577.17
21257-12570.6070.61
31270-12700.6130.62
41081-10810.5220.53
51161-11610.5600.57
61061-10610.5120.52
15min11303-13030.6290.597.930.640.607.80
21072-10720.5170.53
31209-12090.5840.60
41181-11810.5700.58
51336-13360.6450.66
61173-11730.5660.58
20min11275-12750.6150.597.320.630.606.76
21127-11270.5440.56
31174-11740.5670.59
41229-12290.5930.61
51357-13570.6550.67
61135-11350.5480.57
30min11382-13820.6670.608.140.690.627.63
21147-11470.5540.58
31165-11650.5620.59
41147-11470.5540.58
51313-13130.6340.66
61293-12930.6240.65
45min11334-13340.6440.6210.500.680.669.70
21178-11780.5690.60
31243-12430.6000.63
41131-11310.5460.58
51369-13690.6610.69
61499-14990.7240.75
60min11360-13600.6560.7011.430.700.7410.82
21289-12890.6220.66
31387-13870.6700.71
41460-14600.7050.74
51761-17610.8500.89
61411-14110.6810.72
极限11519-15190.7330.7010.300.780.759.83
21428-14280.6890.73
31712-17120.8260.87
41265-12650.6110.65
51388-13880.6700.72
61416-14160.6840.73
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%
118.152097862094882096412098232090472095570.15
218.172114392108052111220.22
单位质量响应值RSD%判断
11545.8411619.260.45数据可信
供试品溶液-12564941批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11225-12250.5920.657.520.590.647.39
21374-13740.6640.66
31201-12010.5800.58
41415-14150.6840.68
51386-13860.6700.67
61435-14350.6930.69
10min11644-16440.7940.836.700.800.846.73
21878-18780.9070.91
31693-16930.8180.82
41827-18270.8830.89
51566-15660.7570.76
61739-17390.8400.85
15min11877-18770.9070.926.530.920.946.59
21921-19210.9280.95
31712-17120.8270.84
42095-20951.0121.03
51963-19630.9490.96
61898-18980.9170.93
20min11863-18630.9001.047.970.931.077.66
22040-20400.9861.01
32197-21971.0621.09
42326-23261.1241.15
52230-22301.0781.10
62261-22611.0931.12
30min12360-23601.1401.193.811.181.233.66
22447-24471.1821.22
32377-23771.1491.19
42447-24471.1821.22
52611-26111.2621.30
62518-25181.2171.26
45min12880-28801.3921.353.821.441.403.67
22709-27091.3091.36
32788-27881.3471.40
42911-29111.4071.46
52626-26261.2691.32
62795-27951.3511.40
60min13181-31811.5371.523.171.601.593.02
23050-30501.4741.54
33206-32061.5491.61
43293-32931.5911.66
53025-30251.4621.53
63146-31461.5201.59
极限13195-31951.5441.669.911.621.749.57
23269-32691.5801.66
33376-33761.6311.71
43416-34161.6511.74
53243-32431.5671.65
64108-41081.9852.07
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