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%
117.401945961948441943791947101944721946000.10
217.411952191950011951100.08
单位质量响应值RSD%判断
11183.9111206.780.15数据可信
供试品溶液-2024122421批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.13156.840.000.13156.50
2868-8680.4340.43
3-0.0000.00
4-0.0000.00
5671-6710.3350.34
6-0.0000.00
10min11979-19790.9891.016.210.991.016.43
22083-20831.0411.05
32024-20241.0121.01
41828-18280.9140.91
52199-21991.0991.10
61956-19560.9780.98
15min12551-25511.2750.9351.611.290.9450.99
22556-25561.2781.29
3677-6770.3380.35
42178-21781.0891.10
52593-25931.2961.31
6597-5970.2980.31
20min1528-5280.2640.4492.740.290.4687.45
2525-5250.2620.29
32544-25441.2721.29
4592-5920.2960.32
5540-5400.2700.30
6551-5510.2750.29
30min1597-5970.2980.6276.790.330.6572.78
2610-6100.3050.34
3611-6110.3050.33
42421-24211.2101.24
5695-6950.3470.38
62526-25261.2631.28
45min1567-5670.2830.4784.040.310.5078.75
2735-7350.3670.40
3592-5920.2960.33
4581-5810.2900.33
52545-25451.2721.31
6617-6170.3080.34
60min1883-8830.4410.3416.990.480.3814.61
2716-7160.3580.40
3681-6810.3400.38
4583-5830.2910.33
5575-5750.2870.34
6624-6240.3120.35
极限1613-6130.3060.314.130.350.364.97
2641-6410.3200.37
3657-6570.3280.37
4634-6340.3170.36
5643-6430.3210.38
6584-5840.2920.33
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%
117.401951401950831952831951221954611952180.08
217.411949221950751949980.06
单位质量响应值RSD%判断
11219.4311200.340.13数据可信
供试品溶液-2024122421批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min11861-18610.9290.997.610.930.997.75
21831-18310.9140.91
31992-19920.9950.99
41931-19310.9640.96
52243-22431.1201.12
62055-20551.0261.03
15min12624-26241.3100.8853.761.320.9053.01
22237-22371.1171.13
3523-5230.2610.27
42249-22491.1231.13
52410-24101.2031.22
6589-5890.2940.31
20min1809-8090.4040.6580.070.430.6777.51
2628-6280.3140.34
32470-24701.2331.25
4538-5380.2690.29
52803-28031.3991.43
6564-5640.2820.30
30min1697-6970.3480.7768.640.380.8066.21
2513-5130.2560.28
32329-23291.1631.19
4541-5410.2700.30
52641-26411.3191.36
62554-25541.2751.29
45min1650-6500.3250.316.580.360.357.23
2655-6550.3270.36
3649-6490.3240.36
4581-5810.2900.32
5624-6240.3120.37
6558-5580.2790.31
60min12624-26241.3100.4884.781.350.5278.04
2545-5450.2720.30
3686-6860.3430.39
4612-6120.3060.34
5633-6330.3160.38
6671-6710.3350.37
极限1690-6900.3450.4881.220.400.5373.41
2724-7240.3610.40
3589-5890.2940.34
4555-5550.2770.31
5688-6880.3440.41
62572-25721.2841.32
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%
117.401957431958741956991958011959601958150.06
217.411952501958021955260.20
单位质量响应值RSD%判断
11253.7411230.670.15数据可信
供试品溶液-12461045批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1781-7810.3890.4210.830.390.4210.95
2777-7770.3870.39
3938-9380.4670.47
4854-8540.4250.43
5727-7270.3620.36
6946-9460.4710.47
10min11031-10310.5130.505.600.520.505.57
21018-10180.5070.51
3931-9310.4630.47
4970-9700.4830.49
5984-9840.4900.49
61093-10930.5440.55
15min11097-10970.5460.554.810.560.564.78
21157-11570.5760.59
31129-11290.5620.57
41112-11120.5540.56
51003-10030.4990.51
61089-10890.5420.55
20min11197-11970.5960.576.250.610.596.22
21112-11120.5540.57
31086-10860.5410.56
41204-12040.5990.62
51051-10510.5230.54
61223-12230.6090.63
30min11142-11420.5690.585.520.590.605.51
21185-11850.5900.61
31198-11980.5960.62
41170-11700.5820.61
51065-10650.5300.55
61259-12590.6270.65
45min11124-11240.5600.594.900.590.624.83
21157-11570.5760.61
31222-12220.6080.64
41285-12850.6400.67
51157-11570.5760.60
61216-12160.6050.64
60min11240-12400.6170.625.140.650.665.47
21290-12900.6420.68
31217-12170.6060.64
41288-12880.6410.68
51144-11440.5700.60
61323-13230.6590.70
极限11262-12620.6280.643.700.670.683.58
21302-13020.6480.69
31224-12240.6090.65
41304-13040.6490.69
51228-12280.6110.65
61341-13410.6680.71
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%
117.401957711955681957181955451952721955750.10
217.411952661951911952280.03
单位质量响应值RSD%判断
11239.9411213.560.17数据可信
供试品溶液-12461045批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1920-9200.4590.419.140.460.419.48
2837-8370.4170.42
3814-8140.4060.41
4818-8180.4080.41
5815-8150.4060.41
6688-6880.3430.34
10min1980-9800.4890.505.230.490.515.40
21090-10900.5430.55
3986-9860.4920.50
41037-10370.5170.52
5936-9360.4670.47
61024-10240.5100.51
15min11147-11470.5720.553.520.580.563.48
21082-10820.5390.55
31135-11350.5660.58
41042-10420.5190.53
51093-10930.5450.55
61114-11140.5550.56
20min11176-11760.5860.592.780.600.602.92
21232-12320.6140.63
31207-12070.6020.62
41175-11750.5860.60
51139-11390.5680.58
61164-11640.5800.60
30min11147-11470.5720.583.870.600.603.81
21145-11450.5710.59
31239-12390.6180.64
41121-11210.5590.58
51122-11220.5590.58
61177-11770.5870.61
45min11210-12100.6030.603.780.630.633.87
21149-11490.5730.60
31155-11550.5760.61
41173-11730.5850.61
51240-12400.6180.65
61257-12570.6270.66
60min11157-11570.5770.626.670.610.656.62
21329-13290.6630.70
31277-12770.6370.67
41268-12680.6320.67
51123-11230.5600.59
61300-13000.6480.68
极限11402-14020.6990.7730.630.740.8229.37
22511-25111.2521.30
31319-13190.6580.70
41407-14070.7010.74
51256-12560.6260.67
61406-14060.7010.74
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