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%
118.122673302666182672482668302668612669770.12
218.092665842665582665710.01
单位质量响应值RSD%判断
14733.8314735.820.01数据可信
供试品溶液-24112201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%
5min12082-20820.7910.918.770.790.918.80
22578-25780.9790.98
32659-26591.0101.01
42420-24200.9190.92
52279-22790.8660.87
62324-23240.8830.88
10min15600-56002.1272.193.802.132.203.83
25943-59432.2572.26
36109-61092.3202.33
45780-57802.1952.20
55556-55562.1102.12
65625-56252.1372.14
15min111258-112584.2764.332.464.294.352.50
211501-115014.3694.39
311945-119454.5374.56
411246-112464.2724.29
511244-112444.2714.29
611267-112674.2804.30
20min115060-150605.7205.702.855.765.742.82
215127-151275.7465.79
315745-157455.9816.02
414698-146985.5835.62
514879-148795.6525.69
614523-145235.5165.56
30min123407-234078.8919.072.088.969.142.07
224022-240229.1259.20
324713-247139.3879.46
424037-240379.1309.20
523554-235548.9479.02
623482-234828.9198.99
45min136510-3651013.86813.890.7513.9914.010.75
236591-3659113.89914.02
337044-3704414.07114.20
436626-3662613.91214.03
536238-3623813.76513.89
636397-3639713.82513.95
60min145820-4582017.40417.671.6917.6017.871.68
246410-4641017.62817.83
347602-4760218.08118.29
445903-4590317.43617.64
547370-4737017.99318.19
645984-4598417.46717.66
极限151354-5135419.50620.071.8419.8020.371.83
252542-5254219.95820.26
354380-5438020.65620.96
452893-5289320.09120.39
552831-5283120.06720.37
652998-5299820.13120.43
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%
118.122669132667382666792662242669842667080.12
218.092664782660852662820.11
单位质量响应值RSD%判断
14718.9814719.850.01数据可信
供试品溶液-24112201批-磷酸盐溶液(pH6.8)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1878-8780.3340.338.850.330.338.71
2842-8420.3200.32
3917-9170.3490.35
4982-9820.3730.37
5773-7730.2940.29
6803-8030.3050.31
10min11117-11170.4250.4214.800.430.4215.02
2790-7900.3000.30
31246-12460.4740.48
41146-11460.4360.44
51211-12110.4600.46
61153-11530.4380.44
15min11549-15490.5890.602.470.590.602.23
21543-15430.5870.59
31598-15980.6080.61
41631-16310.6200.62
51547-15470.5880.59
61534-15340.5830.59
20min11747-17470.6640.725.050.670.734.98
21992-19920.7570.76
32001-20010.7610.77
41850-18500.7030.71
51894-18940.7200.73
61865-18650.7090.72
30min12456-24560.9340.962.150.950.972.21
22482-24820.9440.95
32587-25870.9841.00
42579-25790.9810.99
52499-24990.9500.96
62495-24950.9490.96
45min13440-34401.3081.352.051.321.362.21
23555-35551.3521.37
33633-36331.3811.40
43603-36031.3701.39
53542-35421.3471.36
63479-34791.3231.34
60min14511-45111.7151.762.791.741.782.77
24703-47031.7881.81
34798-47981.8241.85
44718-47181.7941.82
54517-45171.7181.74
64505-45051.7131.74
极限15306-53062.0181.992.912.052.032.88
25104-51041.9411.97
35220-52201.9852.02
45197-51971.9762.01
55521-55212.0992.13
65127-51271.9491.98
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%
118.122671072668702668492672052669972670060.06
218.092660282667632663960.20
单位质量响应值RSD%判断
14735.4314726.150.05数据可信
供试品溶液-24112201批-醋酸盐溶液(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%
5min1-0.0000.10156.320.000.10156.55
2-0.0000.00
3-0.0000.00
4693-6930.2630.26
5-0.0000.00
6862-8620.3280.33
10min12215-22150.8420.797.890.840.807.91
21886-18860.7170.72
32015-20150.7660.77
42249-22490.8540.86
51927-19270.7320.73
62238-22380.8500.85
15min1513-5130.1950.8438.370.200.8538.16
22478-24780.9420.95
32617-26170.9941.00
42539-25390.9650.97
52319-23190.8810.89
62819-28191.0711.08
20min12654-26541.0080.7256.411.010.7255.75
22654-26541.0081.02
3563-5630.2140.22
4518-5180.1970.21
52147-21470.8160.82
62772-27721.0531.07
30min1551-5510.2090.3598.420.220.3694.62
2564-5640.2140.23
32769-27691.0521.06
4551-5510.2090.22
5521-5210.1980.21
6568-5680.2160.23
45min1659-6590.2500.3694.560.260.3791.54
2585-5850.2220.24
3521-5210.1980.21
4593-5930.2250.24
5536-5360.2040.22
62755-27551.0471.07
60min1618-6180.2350.233.600.250.252.10
2601-6010.2280.25
3578-5780.2200.24
4627-6270.2380.25
5578-5780.2200.24
6580-5800.2200.25
极限1685-6850.2600.257.500.280.277.20
2689-6890.2620.28
3734-7340.2790.30
4692-6920.2630.28
5624-6240.2370.25
6597-5970.2270.25
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%
118.122652462659352662442656682655352657260.15
218.092667052669262668160.06
单位质量响应值RSD%判断
14664.7914749.360.41数据可信
供试品溶液-24112201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%
5min1641-6410.2443.31143.990.243.30144.04
2657-6570.2500.25
324531-245319.3369.34
425129-251299.5639.56
5535-5350.2040.20
6622-6220.2370.24
10min1808-8080.3070.315.690.310.339.81
2823-8230.3130.31
3821-8210.3120.36
4805-8050.3060.36
5741-7410.2820.28
6885-8850.3370.34
15min11004-10040.3820.3719.600.390.4023.63
2650-6500.2470.25
31043-10430.3970.45
41244-12440.4730.53
51024-10240.3900.39
6947-9470.3600.36
20min11135-11350.4320.436.250.440.4511.12
2997-9970.3790.38
31201-12010.4570.51
41159-11590.4410.50
51119-11190.4260.43
61093-10930.4160.42
30min11389-13890.5290.543.430.540.566.01
21378-13780.5240.53
31456-14560.5540.61
41403-14030.5340.59
51487-14870.5660.57
61364-13640.5190.53
45min11689-16890.6430.678.620.650.708.18
22059-20590.7840.79
31742-17420.6630.72
41692-16920.6440.71
51647-16470.6270.64
61712-17120.6520.66
60min12157-21570.8210.839.870.830.869.84
22014-20140.7660.78
32226-22260.8470.91
42104-21040.8010.87
52020-20200.7690.78
62593-25930.9871.00
极限12266-22660.8620.862.310.880.904.17
22255-22550.8580.88
32205-22050.8390.91
42330-23300.8870.96
52194-21940.8350.85
62294-22940.8730.89
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