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%
110.918283382729828648258382531827080.18
210.978229582045821700.22
单位质量响应值RSD%判断
7580.937490.430.85数据可信
供试品溶液-25090901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%
10min142311-4231150.28258.307.9450.2858.307.94
249454-4945458.77158.77
350633-5063360.17260.17
454089-5408964.27964.28
549976-4997659.39159.39
647870-4787056.88856.89
15min173475-7347587.31786.902.2187.8887.552.21
274255-7425588.24488.90
371644-7164485.14185.81
475596-7559689.83790.55
571483-7148384.95085.61
672310-7231085.93286.56
30min178305-7830593.05789.973.0994.5991.583.04
275055-7505589.19590.83
372935-7293586.67588.29
478309-7830993.06294.77
573394-7339487.22188.82
676224-7622490.58492.17
45min178627-7862793.43990.142.4196.0092.762.37
275857-7585790.14892.77
374224-7422488.20790.78
477398-7739891.97994.73
574120-7412088.08390.66
674892-7489289.00191.59
60min178631-7863193.44489.452.7997.0593.062.72
274839-7483988.93892.56
372882-7288286.61290.17
476540-7654090.95994.73
573508-7350887.35690.91
675213-7521389.38292.96
90min176269-7626990.63788.751.5995.2893.361.59
274917-7491789.03193.64
373366-7336687.18791.71
475819-7581990.10294.88
573961-7396187.89492.42
673756-7375687.65192.23
120min175678-7567889.93587.252.1995.5892.842.15
274114-7411488.07693.68
371577-7157785.06190.55
474459-7445988.48694.27
571842-7184285.37690.88
672830-7283086.55092.10
极限1-0.0000.00-6.656.561.93
2-0.0006.58
3-0.0006.43
4-0.0006.76
5-0.0006.45
6-0.0006.51
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%
110.918267382458825658251382752825920.15
210.978281082267825380.47
单位质量响应值RSD%判断
7570.307523.970.44数据可信
供试品溶液-25090901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%
10min12346-23462.7843.5612.842.783.5612.88
23326-33263.9463.95
32833-28333.3623.36
42969-29693.5233.52
53409-34094.0454.04
63101-31013.6803.68
15min13042-30423.6093.9710.993.644.0110.91
22830-28303.3583.40
33663-36634.3464.38
43408-34084.0444.08
53805-38054.5154.56
63320-33203.9393.98
30min13495-34954.1474.293.284.224.373.37
23665-36654.3494.43
33750-37504.4504.54
43497-34974.1494.23
53734-37344.4314.53
63533-35334.1924.28
45min13737-37374.4343.9519.624.554.0818.96
23946-39464.6824.81
32826-28263.3533.49
42402-24022.8502.98
53966-39664.7064.85
63080-30803.6553.79
60min13824-38244.5374.2226.854.704.3925.81
23468-34684.1154.30
33707-37074.3994.57
44193-41934.9755.14
54405-44055.2275.42
61733-17332.0562.23
90min13728-37284.4234.6210.924.644.8410.36
24647-46475.5145.74
34080-40804.8415.06
43650-36504.3314.55
53446-34464.0894.34
63787-37874.4934.69
120min13620-36204.2954.2412.414.564.5111.69
24175-41754.9545.24
33355-33553.9814.26
44011-40114.7595.02
53095-30953.6723.97
63186-31863.7804.02
极限1-0.0000.00-0.310.325.93
2-0.0000.34
3-0.0000.32
4-0.0000.32
5-0.0000.34
6-0.0000.29
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%
110.918219682435825098233182995824930.37
210.978272282782827520.06
单位质量响应值RSD%判断
7561.237543.480.17数据可信
供试品溶液-25090901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%
10min150332-5033259.68063.654.9059.6863.654.90
256031-5603166.43766.44
357547-5754768.23568.23
452691-5269162.47762.48
552587-5258762.35462.35
652881-5288162.70262.70
15min155546-5554665.86267.282.6566.5367.992.67
258477-5847769.33870.08
358377-5837769.21969.98
455675-5567566.01566.71
557296-5729667.93768.63
655093-5509365.32566.02
30min159107-5910770.08572.846.4971.4874.296.42
266920-6692079.34980.86
364395-6439576.35577.88
458874-5887469.80871.24
562962-6296274.65676.10
656314-5631466.77368.20
45min160858-6085872.16174.814.0074.3377.074.01
265929-6592978.17480.56
365996-6599678.25380.63
462399-6239973.98876.19
563377-6337775.14877.42
659970-5997071.10873.27
60min166472-6647278.81778.214.3581.7981.304.32
267648-6764880.21283.47
369663-6966382.60185.85
464323-6432376.26979.29
566304-6630478.61881.73
661333-6133372.72475.68
90min168557-6855781.29080.166.1685.1484.125.88
272654-7265486.14890.30
361084-6108472.42976.59
468396-6839681.09984.97
570360-7036083.42887.41
664552-6455276.54180.30
120min172681-7268186.18079.219.2690.9384.078.82
273985-7398587.72692.83
367610-6761080.16785.13
456997-5699767.58372.36
564467-6446776.44081.35
665101-6510177.19281.80
极限169653-6965382.58981.595.1688.3087.335.06
274625-7462588.48594.57
370424-7042483.50389.36
466654-6665479.03384.56
566857-6685779.27485.04
664649-6464976.65682.13
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