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%
118.152013732037282040192044522050752037290.70
2 18.072023242018772021000.16
单位质量响应值RSD%判断
11224.7411184.280.26数据可信
供试品溶液-2025010621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%
5min13033-30331.5151.511.761.521.511.68
23046-30461.5221.52
32978-29781.4881.49
42993-29931.4951.50
52960-29601.4791.48
63105-31051.5511.55
10min15931-59312.9632.883.212.982.903.23
25772-57722.8832.90
35965-59652.9803.00
45802-58022.8982.91
55454-54542.7242.74
65697-56972.8462.86
15min19917-99174.9544.852.235.004.902.24
29788-97884.8894.94
39881-98814.9364.99
49747-97474.8694.92
59339-93394.6654.71
69585-95854.7884.84
20min113456-134566.7226.552.346.836.652.36
212947-129476.4676.57
313268-132686.6286.73
413220-132206.6046.71
512583-125836.2856.38
613176-131766.5826.68
30min121372-2137210.67610.682.8810.8610.862.86
221908-2190810.94411.12
322281-2228111.13011.31
420834-2083410.40710.58
520700-2070010.34010.51
621181-2118110.58010.76
45min130491-3049115.23115.642.9115.5315.942.84
230595-3059515.28315.58
332278-3227816.12416.43
432296-3229616.13316.42
531796-3179615.88316.17
630417-3041715.19415.49
60min141333-4133320.64720.831.6221.1121.301.60
242597-4259721.27821.74
342466-4246621.21321.69
440926-4092620.44320.91
541595-4159520.77821.24
641333-4133320.64721.11
极限147661-4766123.80823.701.1724.5024.401.16
247884-4788423.91924.62
348069-4806924.01124.73
446584-4658423.27023.97
547443-4744323.69924.39
647042-4704223.49824.19
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%
118.152030032043772034812045062055162041770.48
2 18.072040522054792047660.50
单位质量响应值RSD%判断
11249.4211331.820.52数据可信
供试品溶液-2025010621批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1885-8850.4390.488.740.440.489.05
2887-8870.4400.44
31005-10050.4980.50
41066-10660.5280.53
5912-9120.4520.45
61061-10610.5260.53
10min11218-12180.6040.615.090.610.615.11
21099-10990.5450.55
31254-12540.6220.63
41266-12660.6280.63
51254-12540.6220.63
61233-12330.6110.62
15min11501-15010.7440.743.890.760.753.63
21461-14610.7240.74
31593-15930.7900.80
41426-14260.7070.72
51501-15010.7440.76
61460-14600.7240.74
20min11573-15730.7800.806.420.800.826.60
21481-14810.7340.75
31785-17850.8850.91
41579-15790.7830.80
51638-16380.8120.83
61678-16780.8320.85
30min12170-21701.0761.112.571.101.142.49
22313-23131.1471.17
32257-22571.1191.15
42300-23001.1401.17
52197-21971.0891.12
62216-22161.0991.13
45min13005-30051.4901.493.771.531.533.63
23006-30061.4901.53
33207-32071.5901.63
42892-28921.4341.48
52909-29091.4421.48
62971-29711.4731.51
60min13857-38571.9121.922.981.971.982.94
23941-39411.9542.01
34010-40101.9882.05
43674-36741.8211.88
53824-38241.8961.95
63890-38901.9281.99
极限14304-43042.1342.191.832.212.271.88
24451-44512.2062.28
34458-44582.2102.29
44349-43492.1562.23
54518-45182.2402.32
64470-44702.2162.30
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%
118.152046062042432052262053782040412046990.29
2 18.072041712059902050800.63
单位质量响应值RSD%判断
11278.1811349.200.45数据可信
供试品溶液-2025010621批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.04244.950.000.04244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5539-5390.2670.27
6-0.0000.00
10min1641-6410.3170.3616.590.320.3616.72
2627-6270.3100.31
3641-6410.3170.32
4824-8240.4080.41
5710-7100.3510.35
6921-9210.4560.46
15min1704-7040.3480.359.300.350.359.25
2658-6580.3260.33
3641-6410.3170.32
4822-8220.4070.41
5725-7250.3590.37
6676-6760.3340.34
20min1723-7230.3580.3816.900.370.3916.38
2676-6760.3340.34
3821-8210.4060.41
41000-10000.4950.50
5785-7850.3880.40
6635-6350.3140.32
30min1768-7680.3800.4010.890.390.4110.33
2699-6990.3460.36
3756-7560.3740.39
4927-9270.4590.47
5887-8870.4390.45
6769-7690.3800.39
45min1820-8200.4060.417.460.420.436.94
2752-7520.3720.39
3940-9400.4650.48
4805-8050.3980.42
5849-8490.4200.44
6850-8500.4200.44
60min1944-9440.4670.456.610.490.476.25
2849-8490.4200.44
3954-9540.4720.49
4957-9570.4730.50
5888-8880.4390.46
6817-8170.4040.43
极限1877-8770.4340.443.430.460.473.30
2925-9250.4580.48
3920-9200.4550.48
4934-9340.4620.49
5878-8780.4340.46
6862-8620.4260.45
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%
118.152049902054562051572032792061672050100.53
2 18.072049632051842050740.08
单位质量响应值RSD%判断
11295.3211348.870.34数据可信
供试品溶液-2025010621批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1954-9540.4720.4111.500.470.4011.56
2856-8560.4230.42
3828-8280.4090.41
4850-8500.4200.42
5672-6720.3320.33
6773-7730.3820.38
10min11071-10710.5290.5812.220.530.5812.20
21137-11370.5620.57
31433-14330.7080.71
41124-11240.5560.56
51031-10310.5100.51
61184-11840.5850.59
15min11314-13140.6500.655.030.660.664.71
21228-12280.6070.62
31334-13340.6590.67
41318-13180.6520.66
51235-12350.6110.62
61404-14040.6940.70
20min11522-15220.7520.744.320.770.764.17
21382-13820.6830.70
31504-15040.7430.76
41498-14980.7410.76
51548-15480.7650.78
61566-15660.7740.79
30min11757-17570.8690.892.530.900.922.47
21777-17770.8780.90
31753-17530.8670.89
41836-18360.9080.93
51868-18680.9230.95
61801-18010.8900.92
45min12125-21251.0501.1317.861.091.1717.10
22115-21151.0461.08
32105-21051.0411.08
42155-21551.0651.10
53132-31321.5481.58
62143-21431.0591.10
60min12509-25091.2401.213.781.291.263.52
22580-25801.2751.32
32362-23621.1681.22
42330-23301.1521.20
52440-24401.2061.26
62475-24751.2231.27
极限12674-26741.3221.331.821.381.391.67
22649-26491.3091.37
32621-26211.2961.36
42681-26811.3251.39
52722-27221.3461.41
62755-27551.3621.42
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