布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.034044134038824040004043574038334040970.07
211.024045394051044048220.10
单位质量响应值RSD%判断
36636.1736735.210.20数据可信
供试品溶液-25082601批-pH4.3
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min114560-145603.5547.2265.633.557.2265.66
250949-5094912.43712.44
349799-4979912.15612.16
411296-112962.7572.76
510871-108712.6542.65
639968-399689.7569.76
15min1106980-10698026.11441.4018.7326.1541.4818.76
2176651-17665143.12143.26
3188534-18853446.02146.16
4183708-18370844.84344.87
5169393-16939341.34941.38
6192245-19224546.92747.04
30min1217492-21749253.09052.433.2053.4252.983.10
2212595-21259551.89552.51
3202871-20287149.52150.17
4219003-21900353.45953.99
5214118-21411852.26652.76
6222750-22275054.37455.00
45min1221781-22178154.13758.104.4655.0659.224.49
2236976-23697657.84659.04
3247617-24761760.44461.64
4231500-23150056.50957.63
5250671-25067161.18962.26
6239574-23957458.48059.71
60min1271280-27128066.22063.593.6467.7465.363.42
2260671-26067163.63065.47
3265101-26510164.71166.58
4266494-26649465.05166.80
5254474-25447462.11763.87
6245029-24502959.81261.70
90min1278320-27832067.93866.895.7870.2069.375.52
2278503-27850367.98370.53
3244037-24403759.57062.16
4271682-27168266.31868.79
5281964-28196468.82871.27
6289735-28973570.72573.27
120min1289383-28938370.63968.712.3473.6571.932.12
2276365-27636567.46170.76
3275836-27583667.33270.58
4279494-27949468.22571.44
5290173-29017370.83274.04
6277596-27759667.76171.10
极限1-0.0000.00-3.803.982.51
2-0.0004.05
3-0.0004.00
4-0.0003.97
5-0.0003.99
6-0.0004.09
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.034034454034744037704033824037684035680.05
211.024036534035284035900.03
单位质量响应值RSD%判断
36588.2136623.410.07数据可信
供试品溶液-25082601批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min134788-347888.51010.6210.558.5110.6210.55
246722-4672211.43011.43
343597-4359710.66510.67
443417-4341710.62110.62
544219-4421910.81710.82
647750-4775011.68111.68
15min178867-7886719.29321.8510.3119.3921.9610.28
2103150-10315025.23425.36
384883-8488320.76520.88
497265-9726523.79423.91
588577-8857721.66921.79
683057-8305720.31920.45
30min1113772-11377227.83233.1518.0628.1433.5017.87
2131232-13123232.10432.51
3126641-12664130.98131.33
4110409-11040927.01027.39
5164977-16497740.35940.72
6165917-16591740.58940.94
45min1169042-16904241.35346.3212.4341.9747.0512.27
2214875-21487552.56653.33
3177328-17732843.38044.07
4208843-20884351.09051.77
5159531-15953139.02739.84
6206405-20640550.49451.30
60min1161132-16113239.41847.8314.2140.5049.0714.02
2227946-22794655.76357.11
3171539-17153941.96443.14
4225784-22578455.23456.48
5185476-18547645.37446.62
6201190-20119049.21850.59
90min1177639-17763943.45646.2722.1644.9748.0421.61
2242136-24213659.23561.20
3120352-12035229.44231.08
4216408-21640852.94154.80
5175647-17564742.96944.72
6202549-20254949.55051.46
120min1119270-11927029.17740.1618.9231.1842.4518.25
2197157-19715748.23150.86
3179729-17972943.96845.94
4193971-19397147.45249.90
5144040-14404035.23737.46
6150742-15074236.87739.34
极限1175775-17577543.00043.2016.0245.3245.9415.45
2181651-18165144.43847.60
3123516-12351630.21632.67
4188266-18826646.05649.04
5182378-18237844.61647.23
6207997-20799750.88353.76
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.034040684039104037004036564034704037610.06
211.024025874025434025650.01
单位质量响应值RSD%判断
36605.7136530.400.15数据可信
供试品溶液-25082601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%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1336-3360.0820.0997.660.080.0996.97
2442-4420.1080.11
3-0.0000.00
4443-4430.1080.11
5950-9500.2330.23
6-0.0000.00
30min1-0.0000.36131.330.000.36131.35
25261-52611.2881.29
3395-3950.0970.10
41511-15110.3700.37
5450-4500.1100.11
61238-12380.3030.30
45min1968-9680.2370.3565.810.240.3666.14
22509-25090.6140.63
3-0.0000.00
41928-19280.4720.48
51011-10110.2480.25
62258-22580.5530.56
60min12190-21900.5360.3852.430.540.3953.00
22040-20400.5000.52
3375-3750.0920.09
42395-23950.5870.60
5767-7670.1880.19
61614-16140.3950.40
90min12759-27590.6760.5185.820.690.5384.15
22053-20530.5030.53
3606-6060.1480.15
42048-20480.5020.52
5-0.0000.01
65120-51201.2541.27
120min11212-12120.2970.5590.260.310.5788.96
22542-25420.6230.66
3893-8930.2190.22
41927-19270.4720.49
5753-7530.1840.19
66150-61501.5061.53
极限11097-10970.2690.3247.640.290.3547.67
21512-15120.3700.41
3784-7840.1920.20
42214-22140.5420.57
5539-5390.1320.14
61749-17490.4280.47
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