厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检院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10000
标示量(mg)12.5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%
112.909452494379950019504494560947020.32
212.869496595157950610.15
单位质量响应值RSD%判断
7341.247391.990.49数据可信
供试品溶液-6033001批-氢氯噻嗪-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%
5min129242-2924231.66130.0018.7231.6630.0018.72
221640-2164023.43023.43
324165-2416526.16426.16
425394-2539427.49527.49
536320-3632039.32539.32
629481-2948131.92031.92
10min179684-7968486.27785.873.9686.4386.023.98
275199-7519981.42181.54
377393-7739383.79683.93
477822-7782284.26184.40
582259-8225989.06589.26
683491-8349190.39990.56
15min187930-8793095.20595.521.1995.7996.101.20
286434-8643493.58594.11
389388-8938896.78497.33
488472-8847295.79296.35
589053-8905396.42197.06
688068-8806895.35495.97
20min186338-8633893.48196.411.8694.5597.471.84
288428-8842895.74496.74
391231-9123198.77999.81
489812-8981297.24398.28
589763-8976397.19098.31
688711-8871196.05197.14
30min188410-8841095.72596.711.4297.2698.251.39
288929-8892996.28797.76
391318-9131898.873100.40
489396-8939696.79298.32
587757-8775795.01896.63
690091-9009197.54599.11
45min187880-8788095.15196.651.2497.1698.681.22
288595-8859595.92597.88
390974-9097498.501100.52
489744-8974497.16999.18
588671-8867196.00798.09
689748-8974897.17399.23
60min187381-8738194.61095.981.6697.1098.491.63
287495-8749594.73497.17
391057-9105798.591101.11
489771-8977197.19899.69
588370-8837095.68198.25
687806-8780695.07197.61
极限189572-8957296.98396.320.7899.9499.300.75
288739-8873996.08198.99
389959-8995997.402100.41
488376-8837695.68898.67
588182-8818295.47898.52
688907-8890796.26399.28
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-202305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1000
标示量(mg)150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%
115.432605002619292613262615392613622613310.20
215.522621202630632625920.26
单位质量响应值RSD%判断
16936.5516919.590.08数据可信
供试品溶液-6033001批-厄贝沙坦-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%
5min130723-3072312.09911.8918.3612.1011.8918.37
224156-241569.5139.51
327493-2749310.82710.83
427352-2735210.77210.77
540209-4020915.83515.84
631258-3125812.31012.31
10min199337-9933739.12139.335.4339.1839.395.44
295089-9508937.44837.50
395656-9565637.67237.73
496309-9630937.92937.98
5108302-10830242.65242.73
6104570-10457041.18241.24
15min1137414-13741454.11754.782.6154.3755.032.63
2135139-13513953.22153.46
3137689-13768954.22554.47
4138434-13843454.51954.76
5145704-14570457.38257.67
6140139-14013955.19055.46
20min1156308-15630861.55863.522.3062.0864.052.31
2159966-15996662.99863.50
3163584-16358464.42364.94
4159428-15942862.78663.30
5167049-16704965.78866.37
6161410-16141063.56764.11
30min1184569-18456972.68874.321.4473.5275.171.44
2188307-18830774.16074.98
3191868-19186875.56276.40
4186971-18697173.63474.46
5189461-18946174.61475.52
6191171-19117175.28876.15
45min1208028-20802881.92683.501.0683.1284.721.07
2211865-21186583.43784.62
3213963-21396384.26485.48
4211647-21164783.35284.55
5214257-21425784.37985.66
6212352-21235283.62984.87
60min1221320-22132087.16188.401.6588.7790.041.63
2221672-22167287.30088.90
3230716-23071690.86192.50
4226064-22606489.02990.64
5225392-22539288.76590.47
6221687-22168787.30688.96
极限1237255-23725593.43792.980.5895.4895.060.56
2236618-23661893.18695.23
3237573-23757393.56295.65
4234053-23405392.17694.24
5234926-23492692.51994.67
6236138-23613892.99795.09
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