阿齐沙坦片片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20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%
110.081029241026741028241031121027621028590.17
210.931108231108471108350.02
单位质量响应值RSD%判断
10204.2710140.440.45数据可信
半片--供试品溶液-2023111921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%
5min163528-6352856.03860.1417.2256.0460.1417.22
262190-6219054.85854.86
360046-6004652.96752.97
491701-9170180.89080.89
565430-6543057.71657.72
666165-6616558.36558.36
10min190379-9037979.72479.876.0680.0480.206.09
286766-8676676.53776.84
390709-9070980.01580.31
4101148-10114889.22389.67
587305-8730577.01277.33
686966-8696676.71377.04
15min197320-9732085.84786.404.4686.6087.184.51
295285-9528584.05184.78
399259-9925987.55788.30
4106137-10613793.62494.57
594738-9473883.56984.32
694974-9497483.77784.53
20min1100131-10013188.32689.864.6889.5691.124.70
297771-9777186.24487.44
3106384-10638493.84295.07
4108806-10880695.97897.44
5101225-10122589.29190.50
696905-9690585.48086.70
30min1104471-10447192.15490.814.1793.8892.564.19
2100939-10093989.03990.71
3106506-10650693.95095.70
4108101-10810195.35697.35
5101307-10130789.36391.07
696325-9632584.96986.66
45min1105896-10589693.41193.472.5995.6595.732.66
2102243-10224390.18992.36
3107230-10723094.58896.86
4110446-11044697.42599.95
5104995-10499592.61794.82
6104952-10495292.57994.74
60min1106628-10662894.05792.654.5496.8195.434.55
2102644-10264490.54393.21
3107976-10797695.24698.04
4111933-11193398.737101.81
5102482-10248290.40093.12
698513-9851386.89989.58
极限1109176-10917696.30594.992.3399.5898.292.36
2104742-10474292.39395.57
3106775-10677594.18797.51
4110135-11013597.151100.77
5110244-11024497.247100.47
6105039-10503992.65595.82
阿齐沙坦片片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20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%
110.081024731024731025451028211027051026030.16
210.931104301099721102010.30
单位质量响应值RSD%判断
10178.8710082.430.68数据可信
半片--供试品溶液-b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%
5min164014-6401456.70058.4510.2156.7058.4510.21
256716-5671650.23650.24
372721-7272164.41264.41
461476-6147654.45254.45
566620-6662059.00959.01
674401-7440165.90165.90
10min191122-9112280.71182.098.2381.0382.418.23
281537-8153772.22172.50
388327-8832778.23578.59
492758-9275882.16082.46
5100349-10034988.88489.21
6101975-10197590.32490.69
15min1103735-10373591.88391.473.5792.6592.263.57
2102054-10205490.39491.07
396613-9661385.57586.37
4104997-10499793.00193.76
5104980-10498092.98693.81
6107256-10725695.00295.87
20min1109624-10962497.09994.112.8098.3795.402.77
2107488-10748895.20796.39
3100904-10090489.37690.64
4105436-10543693.39094.67
5106342-10634294.19295.53
6107683-10768395.38096.78
30min1112457-11245799.60995.432.90101.4297.242.82
2109671-10967197.14198.85
3104499-10449992.56094.32
4107378-10737895.11096.90
5108146-10814695.79097.65
6104291-10429192.37694.30
45min1108191-10819195.83094.592.2298.2096.942.19
2107340-10734095.07697.33
3102526-10252690.81293.09
4107348-10734895.08397.41
5109343-10934396.85099.24
6106018-10601893.90596.34
60min1111573-11157398.82694.612.54101.7297.472.48
2107810-10781095.49298.27
3103653-10365391.81094.59
4105261-10526193.23596.09
5106308-10630894.16297.09
6106246-10624694.10797.07
极限1109705-10970597.17193.083.00100.6296.472.95
2106144-10614494.01797.33
3100486-10048689.00592.30
4103004-10300491.23694.60
5106367-10636794.21497.67
6104789-10478992.81796.30
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