替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.237618987600397597757605757601667604910.12
211.327596217598157597180.02
单位质量响应值RSD%判断
67719.5967112.900.64数据可信
供试品溶液-2024070321批-pH7.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1173997-17399723.22923.317.7523.2323.327.75
2176349-17634923.54323.54
3185599-18559924.77824.78
4174879-17487923.34723.35
5187384-18738425.01625.02
6149580-14958019.96919.97
10min1291958-29195838.97743.855.7439.1143.985.72
2338574-33857445.20045.33
3332079-33207944.33344.47
4344361-34436145.97346.10
5336909-33690944.97845.12
6326779-32677943.62643.74
15min1387010-38701051.66659.657.5252.0160.027.49
2460570-46057061.48761.87
3435104-43510458.08758.47
4484083-48408364.62665.01
5448822-44882259.91860.31
6465334-46533462.12362.48
20min1451705-45170560.30370.709.1560.9471.419.10
2556594-55659474.30675.03
3506916-50691667.67468.38
4583978-58397877.96278.71
5513998-51399868.62069.34
6564521-56452175.36576.06
30min1623990-62399083.30483.545.3684.2784.645.32
2654129-65412987.32788.46
3584831-58483178.07679.16
4661908-66190888.36689.54
5586710-58671078.32779.43
6643015-64301585.84486.96
45min1608101-60810181.18388.535.3982.6190.095.38
2680885-68088590.89992.52
3637081-63708185.05186.57
4696513-69651392.98694.65
5658432-65843287.90289.44
6697907-69790793.17294.77
60min1647993-64799386.50890.603.1588.3992.663.19
2691744-69174492.34994.48
3666316-66631688.95490.94
4702185-70218593.74395.93
5667098-66709889.05991.09
6696580-69658092.99595.11
极限1697792-69779293.15694.121.0795.5296.681.06
2709130-70913094.67097.31
3717026-71702695.72498.21
4700667-70066793.54096.25
5698313-69831393.22695.75
6707018-70701894.38897.02
替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.237702477700697688217694817686647694560.10
211.327606877625487616180.18
单位质量响应值RSD%判断
68517.9067280.741.29数据可信
供试品溶液-2024070321批-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%
5min1168222-16822222.30021.778.8722.3021.778.87
2173329-17332922.97722.98
3139397-13939718.47818.48
4157155-15715520.83220.83
5166058-16605822.01322.01
6181266-18126624.02924.03
10min1266146-26614635.28038.4612.4535.4038.5812.43
2295922-29592239.22739.36
3259318-25931834.37534.48
4291697-29169738.66738.78
5270087-27008735.80335.93
6357596-35759647.40347.54
15min1344404-34440445.65450.6214.3645.9750.9614.33
2382397-38239750.69151.04
3346844-34684445.97846.27
4397228-39722852.65752.99
5337551-33755144.74645.07
6482857-48285764.00864.40
20min1399527-39952752.96160.3815.9653.5360.9915.92
2443474-44347458.78759.41
3425281-42528156.37556.92
4480152-48015263.64964.27
5394993-39499352.36052.93
6589485-58948578.14278.89
30min1485466-48546664.35373.6414.9365.2274.6014.90
2550854-55085473.02173.98
3521421-52142169.12069.98
4598678-59867879.36180.34
5478341-47834163.40964.27
6698506-69850692.59493.78
45min1547982-54798272.64181.5210.0873.8782.8810.11
2619487-61948782.11983.48
3596177-59617779.02980.28
4676847-67684789.72391.14
5552871-55287173.28974.50
6696480-69648092.32694.03
60min1595425-59542578.93083.967.1580.5685.787.27
2639782-63978284.81086.63
3615234-61523481.55683.24
4658028-65802887.22889.14
5584640-58464077.50079.12
6707238-70723893.75295.97
极限1641562-64156285.04686.343.4087.1188.623.56
2657903-65790387.21289.50
3618628-61862882.00584.14
4656697-65669787.05289.45
5647158-64715885.78787.84
6685829-68582990.91493.65
替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.237633077615517592957602477590297606860.24
211.327581547577237579380.05
单位质量响应值RSD%判断
67736.9566955.650.83数据可信
供试品溶液-2024070321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%
5min130906-309064.1303.4412.214.133.4412.24
227697-276973.7013.70
323943-239433.2003.20
422025-220252.9432.94
524418-244183.2633.26
625441-254413.4003.40
10min181570-8157010.90110.0812.2210.9210.1012.19
281584-8158410.90310.92
365688-656888.7798.80
464352-643528.6008.62
572768-727689.7259.74
686575-8657511.57011.59
15min1126663-12666316.92815.6111.8417.0115.6811.82
2124497-12449716.63816.72
396525-9652512.90012.97
4102970-10297013.76113.83
5119474-11947415.96716.04
6130534-13053417.44517.53
20min1154278-15427820.61819.208.8020.8019.368.82
2156675-15667520.93821.11
3128709-12870917.20117.34
4127416-12741617.02817.17
5146738-14673819.61019.77
6148123-14812319.79519.98
30min1171497-17149722.91922.286.1523.2122.546.20
2176249-17624923.55423.84
3154358-15435820.62920.86
4153018-15301820.45020.68
5173945-17394523.24623.52
6171071-17107122.86223.15
45min1170857-17085722.83423.332.7123.2523.722.77
2178774-17877423.89224.31
3172813-17281323.09523.44
4167863-16786322.43422.78
5179098-17909823.93524.33
6178020-17802023.79124.21
60min1173801-17380123.22723.781.5523.7724.301.56
2177910-17791023.77624.33
3177242-17724223.68724.16
4177501-17750123.72224.20
5178817-17881723.89724.43
6182321-18232124.36624.92
极限1170960-17096022.84723.351.4223.5224.011.32
2176175-17617523.54424.23
3174298-17429823.29423.90
4178219-17821923.81824.42
5175339-17533923.43324.10
6173452-17345223.18023.87
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