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%
111.107613777603177581677585657583597593570.19
211.167560617602127581360.39
单位质量响应值RSD%判断
68410.5467933.330.50数据可信
中间条件6月-供试品溶液-2024070521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%
5min1292152-29215238.57038.034.5938.5738.034.59
2265336-26533635.03035.03
3291346-29134638.46438.46
4303939-30393940.12640.13
5281601-28160137.17737.18
6293917-29391738.80338.80
10min1477131-47713162.99163.765.0663.2163.975.05
2445529-44552958.81959.01
3507930-50793067.05767.27
4511709-51170967.55667.78
5473592-47359262.52462.73
6481624-48162463.58463.80
15min1606412-60641280.05984.053.7280.6284.623.72
2611614-61161480.74681.27
3654270-65427086.37786.96
4661712-66171287.36087.96
5654008-65400886.34386.90
6631886-63188683.42283.99
20min1698761-69876192.25192.042.4793.2693.072.44
2698516-69851692.21993.19
3691208-69120891.25492.32
4694740-69474091.72092.80
5726401-72640195.90096.93
6673141-67314188.86989.90
30min1707607-70760793.41989.716.3994.9491.266.29
2709427-70942793.65995.14
3669244-66924488.35489.93
4731046-73104696.51398.11
5635928-63592883.95685.52
6624057-62405782.38883.91
45min1702534-70253492.74992.771.8794.7994.821.85
2703791-70379192.91594.92
3704295-70429592.98295.05
4699674-69967492.37194.50
5723553-72355395.52497.56
6682340-68234090.08392.07
60min1680996-68099689.90692.361.9392.4694.921.89
2691926-69192691.34993.87
3710488-71048893.79996.38
4696285-69628591.92494.57
5718874-71887494.90697.47
6698806-69880692.25794.74
极限1704208-70420892.97091.604.4096.0394.674.25
2643753-64375384.98988.02
3679323-67932389.68592.79
4688237-68823790.86294.01
5723886-72388695.56898.66
6723614-72361495.53298.53
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%
111.107586937589297571857581027564957578810.14
211.167529267516227522740.13
单位质量响应值RSD%判断
68277.5767408.060.91数据可信
中间条件6月-供试品溶液-2024070521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%
5min1303741-30374140.29638.394.8940.3038.394.90
2289992-28999238.47238.47
3281727-28172737.37537.38
4297192-29719239.42739.43
5298393-29839339.58639.59
6265021-26502135.15935.16
10min1492745-49274565.37064.732.1165.5964.952.11
2496304-49630465.84266.06
3468514-46851462.15562.36
4495462-49546265.73065.95
5487429-48742964.66564.88
6487254-48725464.64264.84
15min1660752-66075287.65980.967.3688.2581.547.32
2599222-59922279.49680.08
3586995-58699577.87478.43
4600658-60065879.68680.27
5665145-66514588.24188.82
6549006-54900672.83473.39
20min1717510-71751095.18891.495.2396.2692.525.18
2617461-61746181.91582.94
3699050-69905092.73993.73
4698660-69866092.68893.71
5704548-70454893.46994.54
6700647-70064792.95193.91
30min1722128-72212895.80189.125.8397.4090.655.74
2710075-71007594.20295.68
3633599-63359984.05685.56
4681795-68179590.45091.99
5629734-62973483.54485.13
6653340-65334086.67588.15
45min1634969-63496984.23889.934.6886.3791.964.56
2678635-67863590.03192.03
3648761-64876186.06888.04
4710348-71034894.23896.28
5713388-71338894.64296.69
6681339-68133990.39092.35
60min1664268-66426888.12590.263.3390.7392.793.24
2656793-65679387.13389.63
3705466-70546693.59196.04
4698927-69892792.72395.29
5697879-69787992.58495.16
6658940-65894087.41889.88
极限1711295-71129594.36492.073.7697.4695.103.62
2679466-67946690.14193.13
3680723-68072390.30893.27
4708151-70815193.94797.03
5656903-65690387.14890.24
6727603-72760396.52799.47
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