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%
111.668847588349880658782187787880990.35
211.498726887141872040.11
单位质量响应值RSD%判断
7555.667589.560.32数据可信
供试品溶液-1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%
10min144249-4424952.32753.622.6952.3353.622.69
244307-4430752.39652.40
345724-4572454.07154.07
444778-4477852.95352.95
545515-4551553.82453.82
647501-4750156.17356.17
15min164889-6488976.73578.233.2377.0378.533.23
263391-6339174.96475.25
367121-6712179.37479.67
466656-6665678.82579.12
565318-6531877.24277.54
669568-6956882.26882.58
30min164817-6481776.65080.533.6477.3781.273.62
265293-6529377.21377.92
370773-7077383.69384.43
470029-7002982.81383.55
568994-6899481.58982.32
668698-6869881.23982.01
45min171447-7144784.49083.382.1685.6384.562.13
270312-7031283.14884.28
370773-7077383.69384.90
472276-7227685.47186.66
567777-6777780.15081.33
670490-7049083.35884.58
60min170560-7056083.44180.675.6385.0582.325.53
263849-6384975.50577.10
372501-7250185.73787.41
463201-6320174.73976.41
568669-6866981.20582.83
670533-7053383.40985.09
90min171632-7163284.70985.091.6186.7887.181.60
270161-7016182.96984.99
372323-7232385.52687.67
473744-7374487.20789.29
571995-7199585.13887.22
671857-7185784.97587.12
120min171839-7183984.95484.842.2387.5087.402.18
270449-7044983.31085.79
371996-7199685.13987.76
474722-7472288.36390.93
570563-7056383.44586.00
670875-7087583.81486.43
极限1-0.0000.00-3.023.041.91
2-0.0002.94
3-0.0003.10
4-0.0003.06
5-0.0003.01
6-0.0003.08
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%
111.668755287925875578745388166877310.35
211.498766388249879560.48
单位质量响应值RSD%判断
7524.107655.001.22数据可信
供试品溶液-1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%
10min150778-5077859.91852.5924.2059.9252.5924.20
245358-4535853.52253.52
350313-5031359.36959.37
448573-4857357.31657.32
522906-2290627.02927.03
649459-4945958.36258.36
15min153068-5306862.62058.843.9562.9559.133.96
247477-4747756.02356.32
350753-5075359.88960.22
450066-5006659.07859.40
549536-4953658.45258.60
648289-4828956.98157.31
30min144157-4415752.10559.887.2052.7960.507.07
253140-5314062.70563.31
352534-5253461.99062.65
453673-5367363.33463.98
552146-5214661.53262.01
648819-4881957.60658.25
45min156773-5677366.99269.103.2367.9670.053.26
260716-6071671.64572.60
359915-5991570.70071.71
459779-5977970.53971.54
556014-5601466.09666.91
658148-5814868.61569.58
60min155774-5577465.81369.965.5967.1671.305.54
264841-6484176.51277.87
359519-5951970.23271.63
461049-6104972.03873.43
556796-5679667.01968.20
657751-5775168.14669.49
90min159890-5989070.67073.344.5272.3875.064.38
259649-5964970.38672.17
365938-6593877.80779.60
459521-5952170.23572.03
564379-6437975.96777.52
663513-6351374.94576.67
120min164084-6408475.61976.481.7777.7278.611.79
265352-6535277.11579.29
366770-6677078.78981.01
463749-6374975.22477.40
563959-6395975.47277.45
664980-6498076.67678.81
极限165851-6585177.70473.0510.9780.2275.6110.57
261754-6175472.87075.47
367362-6736279.48782.15
448644-4864457.40060.00
564604-6460476.23378.63
663245-6324574.62977.19
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%
111.668791587716880398691387541876250.51
211.498787287718877950.13
单位质量响应值RSD%判断
7515.017640.991.18数据可信
供试品溶液-1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%
10min113154-1315415.54516.6328.5815.5516.6328.57
211695-1169513.82113.82
310548-1054812.46612.47
410822-1082212.78912.79
518557-1855721.93121.93
619665-1966523.24023.24
15min123711-2371128.02119.9325.6728.1120.0225.62
214797-1479717.48717.56
311583-1158313.68913.76
414282-1428216.87816.95
517130-1713020.24420.37
619663-1966323.23823.37
30min114906-1490617.61621.1828.7017.8621.3828.54
218170-1817021.47321.65
315249-1524918.02118.17
414947-1494717.66417.83
516131-1613119.06319.30
628112-2811233.22333.48
45min122151-2215126.17823.5015.9326.5223.8215.50
223302-2330227.53827.83
319444-1944422.97923.22
421575-2157525.49725.76
518172-1817221.47621.82
614659-1465917.32417.77
60min115646-1564618.49018.0423.3718.9818.4923.05
219437-1943722.97023.42
311827-1182713.97714.35
410576-1057612.49912.90
515320-1532018.10518.56
618761-1876122.17222.71
90min113698-1369816.18815.9323.5316.7816.4822.67
210927-1092712.91313.49
39964-996411.77512.23
418823-1882322.24522.72
514874-1487417.57818.14
612567-1256714.85215.51
120min17665-76659.05814.4124.639.7415.0523.23
210759-1075912.71513.36
315063-1506317.80118.32
414856-1485617.55718.15
514299-1429916.89817.56
610532-1053212.44713.19
极限18492-849210.03610.1426.2210.7610.8624.44
212041-1204114.23014.95
38131-81319.60910.22
46494-64947.6758.37
510225-1022512.08412.84
66115-61157.2278.04
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