美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
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%
118.122634952634242633152632352631822633300.05
218.092628042629132628580.03
单位质量响应值RSD%判断
14532.5614530.570.01数据可信
供试品溶液-24111902批-pH1.0盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110330-103303.9793.5615.623.983.5615.60
27991-79913.0783.08
310049-100493.8703.87
47262-72622.7972.80
58898-88983.4273.43
610974-109744.2274.23
10min133072-3307212.7382.36215.4412.762.38213.49
2674-6740.2600.28
3707-7070.2720.29
4962-9620.3710.39
5642-6420.2470.27
6706-7060.2720.30
15min11272-12720.4900.3718.670.580.4024.05
2769-7690.2960.31
31019-10190.3920.42
4914-9140.3520.37
5857-8570.3300.35
6873-8730.3360.36
20min11215-12150.4680.474.150.560.516.45
21129-11290.4350.46
31229-12290.4730.50
41245-12450.4800.50
51245-12450.4800.50
61277-12770.4920.52
30min11507-15070.5800.6511.230.680.699.49
21719-17190.6620.68
31650-16500.6360.66
41609-16090.6200.64
51637-16370.6300.66
62058-20580.7930.82
45min12230-22300.8590.852.570.960.894.75
22209-22090.8510.88
32280-22800.8780.91
42179-21790.8390.86
52112-21120.8130.84
62185-21850.8420.88
60min13015-30151.1611.084.501.271.136.76
22770-27701.0671.10
32881-28811.1101.15
42740-27401.0551.09
52756-27561.0611.09
62658-26581.0241.06
极限13199-31991.2321.263.581.341.313.50
23292-32921.2681.30
33468-34681.3361.38
43275-32751.2611.30
53214-32141.2381.28
63129-31291.2051.25
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
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%
118.122629802627932629142628492626052628280.06
218.092626392626962626680.02
单位质量响应值RSD%判断
14504.8614520.070.08数据可信
供试品溶液-24112002批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18401-84013.2403.3714.383.243.3714.38
28083-80833.1173.12
36987-69872.6952.69
410198-101983.9333.93
58593-85933.3143.31
610201-102013.9343.93
10min1617-6170.2382.05214.160.262.07212.11
228606-2860611.03211.05
3689-6890.2660.28
4710-7100.2740.30
5706-7060.2720.29
6624-6240.2410.26
15min1957-9570.3690.3912.000.390.4217.04
21236-12360.4770.56
3928-9280.3580.37
41025-10250.3950.42
5901-9010.3470.37
61012-10120.3900.41
20min11287-12870.4960.503.480.520.533.96
21248-12480.4810.56
31264-12640.4870.51
41359-13590.5240.55
51320-13200.5090.53
61247-12470.4810.51
30min11658-16580.6390.652.440.660.684.11
21659-16590.6400.72
31693-16930.6530.67
41716-17160.6620.69
51608-16080.6200.64
61710-17100.6590.69
45min12217-22170.8550.872.770.880.902.07
22150-21500.8290.92
32247-22470.8670.89
42326-23260.8970.93
52298-22980.8860.91
62263-22630.8730.90
60min12824-28241.0891.112.001.121.162.97
22889-28891.1141.21
32944-29441.1351.16
42936-29361.1321.17
52815-28151.0861.12
62932-29321.1311.17
极限13268-32681.2601.314.461.301.364.93
23422-34221.3201.42
33185-31851.2281.26
43554-35541.3711.41
53465-34651.3361.38
63551-35511.3691.41
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
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%
118.122628162628622629892628642627442628550.04
218.092625802626102625950.01
单位质量响应值RSD%判断
14506.3514516.030.05数据可信
供试品溶液-24111901批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113952-139525.3815.576.215.385.576.21
215104-151045.8265.83
313891-138915.3585.36
415095-150955.8225.82
513143-131435.0695.07
615398-153985.9395.94
10min128343-2834310.9327.4774.6310.967.5074.33
228941-2894111.16211.19
3613-6130.2360.27
429141-2914111.24011.27
5817-8170.3150.34
628396-2839610.95210.99
15min11118-11180.4310.3512.030.520.4213.46
2882-8820.3400.43
3838-8380.3230.35
4857-8570.3310.43
5935-9350.3610.39
6825-8250.3180.41
20min1936-9360.3610.374.660.450.457.59
2888-8880.3420.44
3969-9690.3740.41
41009-10090.3890.49
5987-9870.3810.41
6991-9910.3820.48
30min11266-12660.4880.5210.120.580.6010.00
21257-12570.4850.58
31487-14870.5740.61
41264-12640.4880.59
51298-12980.5010.53
61575-15750.6070.71
45min11664-16640.6420.6614.790.740.7415.65
21501-15010.5790.68
31575-15750.6070.65
42187-21870.8440.95
51556-15560.6000.64
61737-17370.6700.77
60min11710-17100.6600.8833.510.760.9628.44
22132-21320.8220.93
33797-37971.4641.51
41966-19660.7580.86
52204-22040.8500.89
61870-18700.7210.83
极限12013-20130.7760.849.140.880.927.76
22178-21780.8400.95
32498-24980.9631.01
42312-23120.8921.00
52065-20650.7960.84
61985-19850.7660.87
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
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%
118.122622352624792624602627012630962625940.13
218.092629242629792629520.02
单位质量响应值RSD%判断
14491.9414535.770.22数据可信
供试品溶液-24112001批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113212-132125.0955.5710.605.095.5710.65
215229-152295.8735.87
315582-155826.0096.01
414418-144185.5605.56
512122-121224.6754.67
616151-161516.2286.23
10min1677-6770.2611.92208.710.291.95205.33
2782-7820.3020.33
3813-8130.3140.35
4707-7070.2730.30
526238-2623810.11810.14
6707-7070.2730.31
15min1974-9740.3760.376.700.410.4210.31
2914-9140.3520.39
3918-9180.3540.39
4970-9700.3740.41
51082-10820.4170.50
6919-9190.3540.39
20min11175-11750.4530.426.510.480.465.23
21172-11720.4520.49
31084-10840.4180.46
41040-10400.4010.44
51038-10380.4000.48
61014-10140.3910.43
30min11184-11840.4570.5110.750.490.5511.07
21292-12920.4980.54
31572-15720.6060.65
41304-13040.5030.54
51343-13430.5180.60
61191-11910.4590.50
45min11803-18030.6950.657.330.730.696.10
21796-17960.6930.73
31630-16300.6290.67
41733-17330.6680.71
51570-15700.6050.70
61509-15090.5820.62
60min11984-19840.7650.786.800.810.835.35
21975-19750.7620.81
32223-22230.8570.90
42149-21490.8290.87
51881-18810.7250.82
61903-19030.7340.78
极限12164-21640.8340.8911.150.880.9410.16
22133-21330.8230.87
32809-28091.0831.13
42229-22290.8600.91
52171-21710.8370.93
62271-22710.8760.93
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