布瑞哌唑口服混悬液项目信息
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%
111.088365383506835268400483629836640.24
2 10.968343383585835090.13
单位质量响应值RSD%判断
7550.907619.430.64数据可信
供试品溶液-25061901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%
10min149260-4926058.15755.0134.2758.1655.0134.26
258046-5804668.53068.53
352332-5233261.78461.78
414559-1455917.18917.19
551556-5155660.86860.87
653822-5382263.54363.54
15min156039-5603966.16166.609.5766.4866.909.67
258525-5852569.09669.48
358653-5865369.24769.59
445955-4595554.25554.35
557960-5796068.42968.77
661314-6131472.38872.74
30min162148-6214873.37372.093.5474.0672.763.69
262422-6242273.69774.46
360518-6051871.44972.18
456888-5688867.16367.56
562259-6225973.50474.22
662118-6211873.33874.09
45min164812-6481276.51878.016.7177.6279.086.75
266745-6674578.80079.97
373612-7361286.90888.03
459821-5982170.62671.40
565887-6588777.78778.91
665557-6555777.39878.56
60min166849-6684978.92377.973.5880.4579.483.56
268933-6893381.38483.00
365931-6593177.83979.45
464963-6496376.69677.86
567493-6749379.68381.24
662094-6209473.30974.90
90min169059-6905981.53282.713.9583.4984.664.06
272530-7253085.63087.69
371171-7117184.02686.07
464909-6490976.63378.22
571499-7149984.41386.41
671195-7119584.05486.05
120min172043-7204385.05586.121.7687.4788.531.87
274249-7424987.66090.20
372213-7221385.25687.76
471235-7123584.10186.12
573777-7377787.10289.57
674178-7417887.57690.04
极限171809-7180984.77990.109.3687.6792.998.87
275894-7589489.60292.63
374078-7407887.45890.44
490548-90548106.903109.38
573802-7380287.13290.09
671787-7178784.75387.71
布瑞哌唑口服混悬液项目信息
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%
111.088586985865859418578885759858440.09
2 10.968387383600837360.24
单位质量响应值RSD%判断
7747.657640.150.99数据可信
供试品溶液-25061901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%
10min149038-4903857.07959.095.5157.0859.095.51
248514-4851456.46956.47
349064-4906457.10957.11
455114-5511464.15164.15
549401-4940157.50157.50
653474-5347462.24262.24
15min156468-5646865.72765.394.8166.0465.714.81
252634-5263461.26461.58
354076-5407662.94363.26
458927-5892768.58968.95
555410-5541064.49564.81
659532-5953269.29369.64
30min162306-6230672.52269.904.0573.2070.594.04
260957-6095770.95271.61
357988-5798867.49668.16
461306-6130671.35872.10
556133-5613365.33766.01
661621-6162171.72572.46
45min162581-6258172.84274.184.2273.9375.264.21
264006-6400674.50175.55
360471-6047170.38671.43
466125-6612576.96778.10
561696-6169671.81272.85
667502-6750278.57079.70
60min165184-6518475.87275.433.9777.3676.923.94
265047-6504775.71277.17
362330-6233072.55073.98
463657-6365774.09575.66
563084-6308473.42874.87
669533-6953380.93482.50
90min169395-6939580.77379.694.6582.6881.604.63
268492-6849279.72281.61
364584-6458475.17477.01
470367-7036781.90583.88
565052-6505275.71877.57
672874-7287484.82386.84
120min170926-7092682.55581.154.8684.9283.504.83
268636-6863679.89082.22
365659-6565976.42578.68
472751-7275184.68087.11
566380-6638077.26479.53
673937-7393786.06088.55
极限173057-7305785.03682.085.9187.8584.885.84
268895-6889580.19182.96
365826-6582676.61979.30
472203-7220384.04286.94
566517-6651777.42480.12
676585-7658589.14292.11
布瑞哌唑口服混悬液项目信息
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%
111.088385783467835128381383690836680.21
2 10.968347384108837900.54
单位质量响应值RSD%判断
7551.267645.070.88数据可信
供试品溶液-25062302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
15min14391-43915.1754.8213.165.184.8213.23
24790-47905.6465.65
33754-37544.4254.42
44277-42775.0415.04
54054-40544.7784.78
63245-32453.8253.82
30min117256-1725620.33817.1231.2220.3717.1531.19
221941-2194125.86025.89
311245-1124513.25413.28
49210-921010.85510.88
514051-1405116.56116.59
613455-1345515.85815.88
45min122192-2219226.15628.6117.4826.3028.7317.46
230141-3014135.52535.70
318868-1886822.23822.34
424899-2489929.34629.43
521522-2152225.36625.48
628013-2801333.01733.13
60min127202-2720232.06134.2314.0832.3534.5114.11
235147-3514741.42541.80
324387-2438728.74328.96
426886-2688631.68831.94
527718-2771832.66932.93
632897-3289738.77339.07
90min129798-2979835.12037.4311.3535.5937.9111.39
236749-3674943.31343.92
326425-2642531.14531.53
433003-3300338.89839.33
530621-3062136.09036.53
633966-3396640.03340.54
120min128760-2876033.89750.7769.2734.5651.4468.42
236012-3601242.44443.29
327515-2751532.43032.98
433308-3330839.25739.90
529219-2921934.43835.08
6103623-103623122.132122.86
极限128265-2826533.31437.379.5834.1638.339.64
235547-3554741.89642.98
328745-2874533.87934.61
434757-3475740.96541.83
530662-3066236.13936.97
632277-3227738.04239.45
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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(%)99.5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%
111.088349083618835438339983539835180.10
2 10.968368383491835870.17
单位质量响应值RSD%判断
7537.737626.550.83数据可信
供试品溶液-25062302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%
10min1-0.00012.36244.950.0012.36244.95
2-0.0000.00
362801-6280174.17574.17
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min13487-34874.1194.7227.164.124.7925.91
23911-39114.6194.62
33309-33093.9084.32
46171-61717.2897.29
53489-34894.1214.12
63601-36014.2534.25
30min115087-1508717.81917.2618.5517.8417.3618.63
218678-1867822.06122.09
315419-1541918.21118.65
413702-1370216.18416.22
510313-1031312.18112.20
614490-1449017.11417.14
45min125135-2513529.68727.4714.1229.8127.6614.04
228952-2895234.19534.34
322784-2278426.91027.45
421462-2146225.34925.48
520126-2012623.77123.86
621089-2108924.90825.03
60min132090-3209037.90235.108.7538.1935.448.74
233651-3365139.74540.08
329422-2942234.75035.43
428120-2812033.21333.48
527894-2789432.94633.17
627133-2713332.04732.30
90min133622-3362239.71137.335.9940.2137.875.92
234125-3412540.30540.86
330598-3059836.13937.02
430927-3092736.52836.98
531163-3116336.80737.21
629199-2919934.48734.92
120min130445-3044535.95935.944.1336.6836.684.26
231575-3157537.29338.08
330792-3079236.36937.45
431843-3184337.61038.27
529135-2913534.41235.02
628766-2876633.97634.60
极限132664-3266438.58038.263.7839.5039.213.99
233443-3344339.50040.49
333246-3324639.26740.55
433252-3325239.27440.14
531266-3126636.92837.73
630504-3050436.02836.84
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