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%
117.401922431938091937281937691946201936340.45
217.411940061951691945880.43
单位质量响应值RSD%判断
11128.3911176.790.31数据可信
供试品溶液-2024122421批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115951-159518.0058.034.678.008.024.68
214833-148337.4447.44
315793-157937.9267.93
416404-164048.2328.23
517098-170988.5818.58
615888-158887.9737.97
10min128696-2869614.4017.60104.4614.497.69103.26
2754-7540.3780.46
3772-7720.3870.48
430551-3055115.33215.42
5616-6160.3090.40
629477-2947714.79314.88
15min1707-7070.3550.384.640.600.5517.71
2727-7270.3650.45
3753-7530.3780.47
4800-8000.4010.66
5746-7460.3740.47
6788-7880.3950.65
20min1897-8970.4500.456.930.700.6313.03
2897-8970.4500.54
3910-9100.4570.55
4942-9420.4730.74
5973-9730.4880.59
6790-7900.3960.65
30min11040-10400.5220.585.420.780.7610.68
21163-11630.5840.68
31173-11730.5890.69
41158-11580.5810.85
51209-12090.6070.72
61212-12120.6080.87
45min11409-14090.7070.692.580.970.8811.74
21324-13240.6640.77
31334-13340.6690.78
41403-14030.7040.98
51374-13740.6900.80
61377-13770.6910.96
60min11568-15680.7870.824.871.061.028.55
21608-16080.8070.92
31619-16190.8120.93
41718-17180.8621.15
51742-17420.8741.00
61547-15470.7761.05
极限11685-16850.8460.926.591.131.137.74
22045-20451.0261.15
31771-17710.8891.01
41886-18860.9461.24
51824-18240.9151.05
61814-18140.9101.20
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%
117.401918741946091936061945791954581940250.71
217.411940101937721938910.09
单位质量响应值RSD%判断
11150.8611136.760.09数据可信
供试品溶液-2024122421批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115429-154297.7498.243.707.758.243.72
216056-160568.0648.06
317044-170448.5608.56
416975-169758.5268.53
516578-165788.3268.33
616361-163618.2178.22
10min1735-7350.3692.70213.030.462.79206.00
2644-6440.3230.41
3689-6890.3460.44
4750-7500.3770.47
5685-6850.3440.44
628740-2874014.43414.53
15min1800-8000.4020.437.920.490.5517.14
2813-8130.4080.50
3822-8220.4130.51
4892-8920.4480.55
5851-8510.4270.52
6981-9810.4930.74
20min1967-9670.4860.496.490.580.6212.42
21079-10790.5420.64
3900-9000.4520.56
4949-9490.4770.58
5925-9250.4650.57
6993-9930.4990.76
30min11158-11580.5820.614.050.680.7411.19
21154-11540.5800.68
31257-12570.6310.74
41219-12190.6120.72
51196-11960.6010.71
61272-12720.6390.90
45min11516-15160.7610.727.310.870.867.02
21514-15140.7600.87
31367-13670.6870.80
41329-13290.6670.78
51562-15620.7850.90
61334-13340.6700.94
60min11722-17220.8650.874.870.981.028.95
21648-16480.8280.95
31747-17470.8771.00
41637-16370.8220.95
51842-18420.9251.05
61817-18170.9131.19
极限12103-21031.0560.984.271.181.146.64
21867-18670.9381.07
31910-19100.9591.09
41911-19110.9601.09
51993-19931.0011.13
61961-19610.9851.27
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%
117.401944611945461947261946781948891946600.09
217.411938111945741941920.28
单位质量响应值RSD%判断
11187.3611154.050.22数据可信
供试品溶液-12461045批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1989-9890.4960.547.970.500.548.19
21116-11160.5590.56
31168-11680.5850.59
41162-11620.5820.58
51108-11080.5550.56
6966-9660.4840.48
10min11365-13650.6840.705.680.690.705.52
21547-15470.7750.78
31348-13480.6750.68
41343-13430.6730.68
51362-13620.6820.69
61359-13590.6810.69
15min11417-14170.7100.764.240.720.774.23
21593-15930.7980.81
31546-15460.7750.79
41530-15300.7670.78
51556-15560.7800.79
61468-14680.7360.75
20min11586-15860.7950.856.030.820.885.59
21646-16460.8250.85
31667-16670.8350.86
41750-17500.8770.90
51665-16650.8340.86
61878-18780.9410.96
30min11915-19150.9590.981.750.991.011.88
21920-19200.9620.99
31966-19660.9851.02
41956-19560.9801.01
51960-19600.9821.01
62008-20081.0061.04
45min12102-21021.0531.135.041.091.175.02
22174-21741.0891.13
32318-23181.1611.20
42333-23331.1691.21
52406-24061.2051.25
62211-22111.1081.15
60min12300-23001.1521.255.051.201.304.89
22490-24901.2481.30
32434-24341.2201.28
42462-24621.2341.29
52568-25681.2871.34
62671-26711.3381.39
极限12507-25071.2561.323.221.321.393.24
22614-26141.3101.38
32642-26421.3241.39
42653-26531.3291.40
52606-26061.3061.38
62769-27691.3871.46
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%
117.401934761940391948101945521946341943020.28
217.411936281943101939690.25
单位质量响应值RSD%判断
11166.7811141.240.17数据可信
供试品溶液-12461045批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11119-11190.5610.628.110.560.628.23
21273-12730.6390.64
31247-12470.6260.63
41244-12440.6240.62
51388-13880.6960.70
61127-11270.5660.57
10min11465-14650.7350.766.130.740.766.02
21589-15890.7970.80
31563-15630.7840.79
41397-13970.7010.71
51621-16210.8130.82
61427-14270.7160.72
15min11557-15570.7810.803.890.800.814.02
21696-16960.8510.87
31590-15900.7980.81
41551-15510.7780.79
51620-16200.8130.83
61524-15240.7650.78
20min11822-18220.9140.894.080.940.914.23
21859-18590.9330.96
31722-17220.8640.89
41771-17710.8890.91
51764-17640.8850.91
61656-16560.8310.85
30min12098-20981.0531.064.291.091.094.20
22053-20531.0301.07
32101-21011.0541.09
42071-20711.0391.07
52277-22771.1431.18
62022-20221.0151.05
45min12387-23871.1981.192.801.241.232.88
22430-24301.2191.27
32364-23641.1861.23
42420-24201.2141.26
52327-23271.1681.22
62252-22521.1301.17
60min12601-26011.3051.302.111.361.352.08
22633-26331.3211.38
32638-26381.3241.38
42596-25961.3031.36
52529-25291.2691.33
62507-25071.2581.31
极限12817-28171.4141.403.871.491.473.78
22902-29021.4561.53
32694-26941.3521.43
42811-28111.4111.48
52852-28521.4311.51
62612-26121.3111.38
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