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%
1 11.088091880836810778111580822809540.17
2 11.028122281045811340.16
单位质量响应值RSD%判断
7306.327362.430.55数据可信
供试品溶液-2821374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%
10min126533-2653332.39631.908.2532.4031.908.25
224168-2416829.50929.51
327540-2754033.62633.63
429029-2902935.44435.44
526316-2631632.13132.13
623168-2316828.28828.29
15min136760-3676044.88345.045.4245.2445.405.44
234921-3492142.63842.97
338643-3864347.18247.56
439940-3994048.76649.16
535685-3568543.57143.93
635397-3539743.21943.53
30min145792-4579255.91156.855.2856.7757.715.28
242582-4258251.99252.79
348969-4896959.79060.69
449348-4934860.25361.19
546497-4649756.77257.61
646198-4619856.40757.20
45min152837-5283764.51366.072.3565.9967.562.41
252833-5283364.50865.89
354571-5457166.63068.19
456177-5617768.59170.20
554536-5453666.58768.06
653727-5372765.60067.02
60min158855-5885571.86172.521.3174.0674.741.39
258909-5890971.92774.02
360101-6010173.38275.68
460628-6062874.02676.39
558788-5878871.77973.99
659097-5909772.15674.31
90min165147-6514779.54378.851.1082.5481.881.12
264148-6414878.32381.22
364233-6423378.42781.55
465148-6514879.54482.73
565269-6526979.69282.70
663543-6354377.58580.54
120min169453-6945384.80182.391.5988.6886.301.56
266486-6648681.17884.94
366937-6693781.72985.72
467827-6782782.81586.89
567358-6735882.24386.14
666818-6681881.58385.40
极限170683-7068386.30384.711.7391.1289.531.56
270346-7034685.89190.56
367316-6731682.19287.09
468947-6894784.18389.18
569596-6959684.97589.78
669394-6939484.72989.45
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%
1 11.088108880933809478094080531808880.26
2 11.028141981239813290.16
单位质量响应值RSD%判断
7300.367380.130.77数据可信
供试品溶液-2821374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%
10min126226-2622631.99629.0616.0432.0029.0616.04
229456-2945635.93735.94
325558-2555831.18131.18
420536-2053625.05425.05
520148-2014824.58124.58
620983-2098325.60025.60
15min138227-3822746.63845.195.8346.9945.515.90
240627-4062749.56649.97
336649-3664944.71345.06
434585-3458542.19442.47
535377-3537743.16143.43
636762-3676244.85045.13
30min147011-4701157.35456.953.5658.2357.783.63
249608-4960860.52361.47
346727-4672757.00857.85
444642-4464254.46455.21
545812-4581255.89256.64
646299-4629956.48657.27
45min153611-5361165.40765.642.8066.9267.102.88
256214-5621468.58270.20
354727-5472766.76868.24
451918-5191863.34164.69
552805-5280564.42365.80
653535-5353565.31466.72
60min157806-5780670.52571.752.4972.7673.942.53
260585-6058573.91576.30
359984-5998473.18275.40
456643-5664369.10671.16
559390-5939072.45774.55
658444-5844471.30373.44
90min162766-6276676.57677.952.1479.6080.942.11
264486-6448678.67481.88
364113-6411378.21981.25
461990-6199075.62978.45
565889-6588980.38683.28
664126-6412678.23581.16
120min163077-6307776.95580.334.9280.8384.184.80
268017-6801782.98287.06
368409-6840983.46187.36
460554-6055473.87777.54
567659-6765982.54686.33
667323-6732382.13685.93
极限165718-6571880.17782.962.3984.9087.702.39
269668-6966884.99790.00
370067-7006785.48390.31
467305-6730582.11486.60
567374-6737482.19886.90
667860-6786082.79187.50
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%
1 11.088181781603814628136281613815710.22
2 11.028105380980810160.07
单位质量响应值RSD%判断
7362.007351.720.10数据可信
供试品溶液-2810778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%
10min124141-2414129.38531.228.5729.3931.228.56
222137-2213726.94626.95
325671-2567131.24831.25
427239-2723933.15633.16
528133-2813334.24434.24
626551-2655132.31932.32
15min134604-3460442.12143.124.3242.4543.464.33
233566-3356640.85841.16
336731-3673144.71045.06
436136-3613643.98644.35
537350-3735045.46445.84
634144-3414441.56141.92
30min145313-4531355.15657.072.9255.9557.902.96
245353-4535355.20555.96
347801-4780158.18559.03
447373-4737357.66458.52
548738-4873859.32560.21
646757-4675756.91457.73
45min152961-5296164.46666.022.5165.8767.482.55
252376-5237663.75465.12
354873-5487366.79368.28
454251-5425166.03667.53
556052-5605268.22869.77
654915-5491566.84468.30
60min157944-5794470.53172.321.7072.6574.511.74
258622-5862271.35773.43
359649-5964972.60774.84
459326-5932672.21374.45
560467-6046773.60275.91
660460-6046073.59475.79
90min163159-6315976.87978.562.0879.7981.552.07
263681-6368177.51580.38
366019-6601980.36083.40
463332-6333277.09080.12
564888-6488878.98482.10
666141-6614180.50983.52
120min167724-6772482.43683.661.2886.2087.531.32
268054-6805482.83786.57
369121-6912184.13688.07
468115-6811582.91286.80
569613-6961384.73588.73
669761-6976184.91588.82
极限169696-6969684.83685.291.8789.5190.091.75
270458-7045885.76490.41
371282-7128286.76791.63
469313-6931384.37089.18
568095-6809582.88787.83
671577-7157787.12691.98
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%
1 11.088049781367809098109981403810550.46
2 11.028088280642807620.22
单位质量响应值RSD%判断
7315.437328.680.13数据可信
供试品溶液-2810778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%
10min122184-2218427.13132.069.9027.1332.069.90
226510-2651032.42232.42
328944-2894435.39935.40
425187-2518730.80430.80
525404-2540431.07031.07
629064-2906435.54635.55
15min134264-3426441.90643.364.0342.2143.724.07
235569-3556943.50243.86
337291-3729145.60846.00
433570-3357041.05741.40
535247-3524743.10843.45
636796-3679645.00245.40
30min139873-3987348.76555.646.4349.5356.476.42
246767-4676757.19758.04
347431-4743158.00958.91
444998-4499855.03355.83
546109-4610956.39257.22
647767-4776758.42059.31
45min154288-5428866.39567.081.5867.7068.531.61
253501-5350165.43366.91
355818-5581868.26669.81
455119-5511967.41268.82
554743-5474366.95268.40
655594-5559467.99269.54
60min158293-5829371.29371.721.9873.3473.922.00
258836-5883671.95874.16
359909-5990973.27075.57
456528-5652869.13571.29
559186-5918672.38674.58
659093-5909372.27274.57
90min165224-6522479.77080.091.3382.6183.091.25
264677-6467779.10182.11
364538-6453878.93182.05
466102-6610280.84483.77
566806-6680681.70584.70
665588-6558880.21583.32
120min169113-6911384.52684.373.0388.2588.262.85
269306-6930684.76388.65
370135-7013585.77689.77
471960-7196088.00891.83
567411-6741182.44586.35
665986-6598680.70284.70
极限169786-6978685.35086.741.6090.0191.571.58
269325-6932584.78689.61
371973-7197388.02492.97
471915-7191587.95392.76
571625-7162587.59992.42
670929-7092986.74791.64
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