非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.654151382415006341492054148211414782141493360.04
210.774172706417775341752300.09
单位质量响应值RSD%判断
389609.01387672.240.36数据可信
供试品溶液-250602批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1257637-2576375.9606.2515.575.966.2515.60
2332658-3326587.6967.70
3269503-2695036.2356.23
4300125-3001256.9436.94
5210674-2106744.8744.87
6251494-2514945.8185.82
10min1583985-58398513.51013.436.7213.5213.446.72
2635029-63502914.69114.70
3548492-54849212.68912.70
4615778-61577814.24614.26
5535157-53515712.38112.39
6563537-56353713.03713.05
15min1702697-70269716.25716.034.2116.2916.064.22
2724508-72450816.76116.80
3643974-64397414.89814.93
4715522-71552216.55316.59
5677002-67700215.66215.69
6693207-69320716.03716.07
20min1740081-74008117.12116.834.3517.1816.894.34
2755957-75595717.48917.55
3667804-66780415.44915.51
4749000-74900017.32817.39
5725055-72505516.77416.83
6727027-72702716.81916.88
30min1771195-77119517.84117.394.4517.9317.484.44
2774491-77449117.91818.01
3686124-68612415.87315.96
4768064-76806417.76917.86
5748629-74862917.31917.40
6762408-76240817.63817.72
45min1797189-79718918.44317.487.3818.5617.607.33
2806372-80637218.65518.78
3691720-69172016.00316.11
4679304-67930415.71515.84
5788321-78832118.23818.35
6771015-77101517.83717.95
60min1794303-79430318.37617.895.6418.5218.035.62
2804829-80482918.61918.77
3690626-69062615.97716.11
4759506-75950617.57117.72
5801952-80195218.55318.69
6787457-78745718.21818.36
90min1804824-80482418.61917.945.8018.8018.125.77
2797211-79721118.44318.63
3687015-68701515.89416.06
4770905-77090517.83518.01
5800763-80076318.52518.70
6791749-79174918.31718.49
120min1840188-84018819.43719.681.0919.6519.881.07
2864174-86417419.99220.21
3856817-85681719.82220.01
4841735-84173519.47319.68
5852956-85295619.73319.94
6847945-84794519.61719.82
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1834510-83451019.30619.581.3519.5519.821.32
2856225-85622519.80820.06
3864243-86424319.99420.22
4839356-83935619.41819.66
5840498-84049819.44519.68
6843728-84372819.51919.76
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.654205731420275041989164196160419394341995000.12
210.774291151429345842923040.04
单位质量响应值RSD%判断
394319.25398542.620.76数据可信
供试品溶液-250603批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1356123-3561238.0778.4110.908.088.4210.92
2426267-4262679.6689.67
3378690-3786908.5898.59
4371868-3718688.4348.43
5389138-3891388.8268.83
6303913-3039136.8936.89
10min1603591-60359113.69013.912.8213.7013.932.83
2642120-64212014.56414.58
3606855-60685513.76413.78
4623668-62366814.14514.16
5611674-61167413.87313.89
6593062-59306213.45113.46
15min1721214-72121416.35816.521.5416.3916.561.55
2740741-74074116.80016.84
3727271-72727116.49516.53
4741664-74166416.82116.86
5727578-72757816.50216.54
6712776-71277616.16616.20
20min1767315-76731517.40317.560.8617.4717.620.85
2774058-77405817.55617.62
3780375-78037517.69917.76
4782376-78237617.74517.81
5774282-77428217.56117.63
6766094-76609417.37517.44
30min1811269-81126918.40018.561.0118.4918.661.03
2829710-82971018.81818.92
3827252-82725218.76218.86
4817433-81743318.54018.64
5814274-81427418.46818.56
6810387-81038718.38018.47
45min1832432-83243218.88019.121.0919.0019.251.10
2857624-85762419.45119.58
3841540-84154019.08719.21
4850119-85011919.28119.41
5837461-83746118.99419.12
6839716-83971619.04519.17
60min1837357-83735718.99219.231.6719.1519.391.68
2867430-86743019.67419.84
3861958-86195819.55019.71
4830883-83088318.84519.00
5843842-84384219.13919.30
6845556-84555619.17819.33
90min1842769-84276919.11419.431.1619.3019.621.15
2867271-86727119.67019.86
3869036-86903619.71019.90
4853961-85396119.36819.56
5852682-85268219.33919.53
6854629-85462919.38319.57
120min1861874-86187419.54818.766.2419.7718.986.17
2845144-84514419.16819.40
3723093-72309316.40016.62
4848517-84851719.24519.47
5846045-84604519.18919.41
6837898-83789819.00419.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1858672-85867219.47518.915.0119.7319.164.94
2843195-84319519.12419.38
3750265-75026517.01617.27
4862583-86258319.56419.82
5844140-84414019.14619.40
6842706-84270619.11319.36
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.654318903431918243152984315847431287543164210.07
210.774307059430791343074860.02
单位质量响应值RSD%判断
405297.75399952.270.94数据可信
供试品溶液-250603批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1329673-3296737.3627.0611.207.367.0611.20
2374800-3748008.3708.37
3292271-2922716.5276.53
4298903-2989036.6756.68
5275095-2750956.1436.14
6325370-3253707.2667.27
10min1618310-61831013.80812.578.0313.8212.588.03
2607494-60749413.56713.58
3506893-50689311.32011.33
4539553-53955312.04912.06
5527308-52730811.77611.79
6577123-57712312.88812.90
15min1723533-72353316.15815.636.0116.1915.666.01
2729041-72904116.28116.32
3620614-62061413.86013.89
4694025-69402515.49915.53
5698394-69839415.59615.63
6733164-73316416.37316.41
20min1766960-76696017.12816.685.0317.1916.745.02
2771441-77144117.22817.29
3671867-67186715.00415.06
4760609-76060916.98617.04
5749896-74989616.74716.80
6761021-76102116.99517.06
30min1804203-80420317.95917.505.5418.0517.585.54
2806349-80634918.00718.10
3697650-69765015.58015.66
4809435-80943518.07618.16
5779622-77962217.41017.49
6803720-80372017.94918.04
45min1837986-83798618.71418.165.0318.8318.285.03
2828571-82857118.50418.63
3730661-73066116.31716.42
4834651-83465118.63918.75
5825174-82517418.42818.54
6823095-82309518.38118.50
60min1846934-84693418.91418.196.5819.0718.346.57
2822134-82213418.36018.51
3706985-70698515.78815.92
4845821-84582118.88919.04
5828665-82866518.50618.65
6836869-83686918.68918.84
90min1842187-84218718.80818.474.3918.9918.654.41
2851778-85177819.02219.21
3755041-75504116.86217.02
4848958-84895818.95919.14
5827663-82766318.48318.66
6836278-83627818.67618.86
120min1791354-79135417.67217.495.3117.8917.705.29
2804028-80402817.95618.17
3700887-70088715.65215.84
4796617-79661717.79018.00
5816655-81665518.23718.44
6790850-79085017.66117.87
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1799068-79906817.84517.484.9218.0917.714.93
2803337-80333717.94018.19
3705349-70534915.75215.96
4791875-79187517.68417.92
5806888-80688818.01918.25
6789455-78945517.63017.87
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