替米沙坦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2500
标示量(mg)40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%
111.113839683839323838693840733840143839710.03
211.033791113791873791490.02
单位质量响应值RSD%判断
34560.8534374.340.39数据可信
供试品溶液-24042201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%
5min1180886-18088647.23243.7710.1347.2343.7710.13
2194350-19435050.74850.75
3148799-14879938.85438.85
4165355-16535543.17743.18
5155739-15573940.66640.67
6160534-16053441.91841.92
10min1255903-25590366.82169.465.6967.0869.705.68
2276517-27651772.20372.49
3281414-28141473.48273.70
4276942-27694272.31472.55
5242224-24222463.24963.47
6263013-26301368.67768.91
15min1334438-33443887.32781.527.3187.9682.157.29
2331647-33164786.59987.28
3307609-30760980.32280.95
4326964-32696485.37686.02
5277667-27766772.50473.08
6294938-29493877.01377.63
20min1360038-36003894.01289.336.4795.1390.416.43
2330863-33086386.39487.56
3356965-35696593.21094.28
4363983-36398395.04296.16
5307132-30713280.19781.18
6333578-33357887.10388.15
30min1351205-35120591.70691.023.7993.3592.603.80
2345824-34582490.30091.94
3360931-36093194.24595.83
4359803-35980393.95195.59
5324550-32455084.74586.17
6349185-34918591.17892.70
45min1351660-35166091.82491.541.7693.9793.621.70
2339675-33967588.69590.84
3348006-34800690.87092.98
4355825-35582592.91295.08
5351858-35185891.87693.77
6356408-35640893.06495.10
60min1353361-35336192.26892.400.7694.9395.000.76
2352012-35201291.91694.55
3352391-35239192.01594.63
4358592-35859293.63496.32
5355336-35533692.78495.19
6351557-35155791.79794.35
极限1351955-35195591.90191.091.7395.0794.201.69
2354050-35405092.44895.60
3345836-34583690.30493.43
4350741-35074191.58494.79
5352557-35255792.05994.98
6337988-33798888.25491.31
替米沙坦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2500
标示量(mg)40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%
111.113784003786063782593781033777753782290.09
211.033773853776833775340.06
单位质量响应值RSD%判断
34044.0134227.920.39数据可信
供试品溶液-24042201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%
5min1144390-14439038.06942.715.5338.0742.715.52
2167857-16785744.25644.26
3167739-16773944.22544.22
4161902-16190242.68642.69
5163620-16362043.13943.14
6166455-16645543.88643.89
10min1253380-25338066.80570.003.8867.0270.243.87
2256153-25615367.53667.78
3276931-27693173.01473.26
4276515-27651572.90473.14
5260363-26036368.64668.89
6269565-26956571.07271.32
15min1316276-31627683.38786.413.1683.9787.033.15
2317914-31791483.81984.44
3327696-32769686.39887.05
4326025-32602585.95886.60
5343652-34365290.60591.23
6334785-33478588.26788.91
20min1342617-34261790.33291.102.6591.3892.212.63
2337583-33758389.00590.09
3348455-34845591.87193.00
4361982-36198295.43896.56
5337340-33734088.94190.07
6345238-34523891.02392.15
30min1360337-36033795.00491.384.8796.5592.994.77
2341599-34159990.06491.64
3315199-31519983.10384.75
4359112-35911294.68196.33
5354032-35403293.34294.96
6349321-34932192.10093.73
45min1354262-35426293.40292.023.1195.4894.143.04
2359064-35906494.66896.75
3329370-32937086.84088.94
4348259-34825991.82094.00
5357065-35706594.14196.28
6346150-34615091.26493.41
60min1348950-34895092.00292.463.6194.6095.093.54
2353916-35391693.31195.92
3327163-32716386.25888.84
4360024-36002494.92297.61
5351357-35135792.63695.30
6362633-36263395.60998.26
极限1353682-35368293.24991.134.1796.3694.284.02
2345286-34528691.03694.16
3352450-35245092.92595.99
4357144-35714494.16297.38
5347832-34783291.70794.88
6317568-31756883.72886.91
替米沙坦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2500
标示量(mg)40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%
111.113826953825473822363823483822253824100.06
211.033809543816053812800.13
单位质量响应值RSD%判断
34420.3434567.540.31数据可信
供试品溶液-2024050921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%
5min1133647-13364734.87139.116.1134.8739.116.11
2154982-15498240.43740.44
3160828-16082841.96341.96
4147650-14765038.52438.52
5150400-15040039.24239.24
6151951-15195139.64739.65
10min1260619-26061968.00067.734.3268.1967.954.31
2272567-27256771.11771.34
3271281-27128170.78271.01
4252985-25298566.00866.22
5256937-25693767.03967.26
6243158-24315863.44463.66
15min1323169-32316984.32081.934.1184.8982.524.09
2333431-33343186.99887.62
3305384-30538479.68080.31
4307314-30731480.18380.76
5316414-31641482.55883.15
6298308-29830877.83378.41
20min1350259-35025991.38887.203.0792.4388.253.04
2328289-32828985.65686.76
3338300-33830088.26889.34
4339075-33907588.47089.50
5322376-32237684.11385.16
6326924-32692485.30086.31
30min1347729-34772990.72891.811.6292.2893.351.56
2350573-35057391.47093.05
3345605-34560590.17491.73
4355651-35565192.79594.31
5350544-35054491.46392.98
6361234-36123494.25295.73
45min1349710-34971091.24590.671.5793.3092.711.54
2352224-35222491.90193.99
3347362-34736290.63292.69
4336976-33697687.92389.96
5350557-35055791.46693.49
6348152-34815290.83992.84
60min1337639-33763988.09689.282.1490.6591.832.06
2337900-33790088.16490.76
3336717-33671787.85590.42
4355553-35555392.77095.29
5345631-34563190.18192.71
6339673-33967388.62691.13
极限1337774-33777488.13189.962.0491.1893.001.95
2336336-33633687.75690.84
3341644-34164489.14192.19
4351229-35122991.64194.68
5350864-35086491.54694.58
6350867-35086791.54794.55
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