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%
111.163948243949833935323941583945203944030.15
211.183864893883933874410.35
单位质量响应值RSD%判断
35340.7734654.831.39数据可信
供试品溶液-24042201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%
5min1135880-13588034.94635.703.8334.9535.703.83
2141779-14177936.46336.46
3143596-14359636.93136.93
4129706-12970633.35833.36
5143063-14306336.79336.79
6138783-13878335.69335.69
10min1250301-25030164.37363.663.9364.5763.863.93
2257499-25749966.22566.43
3255478-25547865.70565.91
4230335-23033559.23859.42
5245823-24582363.22263.43
6245765-24576563.20763.41
15min1304998-30499878.44180.913.1878.9981.463.17
2322602-32260282.96883.54
3313665-31366580.67081.24
4301478-30147877.53578.05
5317609-31760981.68482.24
6327245-32724584.16284.71
20min1341891-34189187.92990.421.9088.9291.431.89
2362335-36233593.18794.22
3354180-35418091.08992.11
4349849-34984989.97590.92
5350946-35094690.25891.27
6350376-35037690.11191.13
30min1365144-36514493.90996.001.1795.3997.511.16
2372593-37259395.82597.37
3377921-37792197.19598.72
4375122-37512296.47597.92
5374955-37495596.43297.94
6373970-37397096.17997.70
45min1347589-34758989.39494.612.8291.3996.652.78
2373771-37377196.12898.21
3366551-36655194.27196.34
4372207-37220795.72697.71
5374960-37496096.43498.48
6372232-37223295.73297.78
60min1339208-33920887.23990.112.0189.7392.681.98
2350903-35090390.24792.86
3345656-34565688.89791.49
4352680-35268090.70493.22
5358955-35895592.31794.90
6354870-35487091.26793.85
极限1331357-33135785.22089.492.5488.2092.552.50
2349777-34977789.95793.07
3345164-34516488.77191.85
4353983-35398391.03994.06
5354441-35444191.15694.25
6352958-35295890.77593.87
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%
111.163763563764813764423762933766483764440.04
211.183828113830733829420.05
单位质量响应值RSD%判断
33731.5434252.421.09数据可信
供试品溶液-2024050921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%
5min1129163-12916334.20036.163.8434.2036.163.84
2141724-14172437.52637.53
3133716-13371635.40635.41
4137680-13768036.45536.46
5134155-13415535.52235.52
6142917-14291737.84237.84
10min1220986-22098658.51461.693.6558.7061.893.65
2243768-24376864.54664.75
3239069-23906963.30263.50
4225280-22528059.65159.85
5235007-23500762.22662.42
6233860-23386061.92262.13
15min1311343-31134382.43980.632.5282.9581.172.49
2301622-30162279.86580.43
3315774-31577483.61284.16
4295151-29515178.15178.69
5303232-30323280.29180.83
6299922-29992279.41579.97
20min1351820-35182093.15688.473.0394.1389.472.99
2331029-33102987.65188.66
3337624-33762489.39790.41
4326388-32638886.42287.39
5334635-33463588.60689.60
6323320-32332085.61086.61
30min1353446-35344693.58791.803.2695.0893.283.20
2349872-34987292.64094.14
3326521-32652186.45887.97
4352452-35245293.32494.77
5357063-35706394.54596.03
6340796-34079690.23791.71
45min1359469-35946995.18294.482.0797.1996.482.03
2359441-35944195.17497.19
3363528-36352896.25698.25
4359422-35942295.16997.14
5356571-35657194.41496.42
6342499-34249990.68892.66
60min1346420-34642091.72690.883.4394.2793.393.32
2324496-32449685.92188.46
3334055-33405588.45290.98
4356582-35658294.41796.91
5347754-34775492.08094.61
6349923-34992392.65495.13
极限1347438-34743891.99690.822.8895.0493.842.79
2345870-34587091.58194.60
3327541-32754186.72889.74
4357153-35715394.56897.59
5339915-33991590.00493.05
6340129-34012990.06193.05
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