布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.949203391478923039168991810918630.35
210.899187992408921440.41
单位质量响应值RSD%判断
8396.988461.340.54数据可信
供试品溶液-25050701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%
5min164151-6415168.15472.383.6368.1572.383.63
270449-7044974.84574.84
368799-6879973.09273.09
467245-6724571.44171.44
570836-7083675.25675.26
667287-6728771.48671.49
10min173008-7300877.56480.272.6877.6880.392.68
272957-7295777.50977.63
376712-7671281.49981.62
477480-7748082.31582.43
576791-7679181.58381.71
676372-7637281.13881.26
15min181056-8105686.11484.002.7586.3684.262.74
281569-8156986.65986.91
375904-7590480.64080.90
479952-7995284.94185.20
577744-7774482.59582.86
678176-7817683.05483.31
20min182095-8209587.21884.543.5587.6084.933.53
279722-7972284.69785.09
380230-8023085.23685.63
474270-7427078.90479.30
581753-8175386.85487.25
679383-7938384.33684.73
30min182580-8258087.73387.491.2488.2688.031.24
282761-8276187.92588.46
383369-8336988.57189.11
480519-8051985.54386.07
582967-8296788.14488.69
681930-8193087.04287.58
45min185326-8532690.65087.872.6091.3388.552.58
282221-8222187.35188.04
379913-7991384.89985.58
484435-8443589.70490.38
583705-8370588.92889.62
680660-8066085.69386.37
60min187719-8771993.19389.304.1494.0290.134.10
282555-8255587.70688.54
385305-8530590.62891.45
486124-8612491.49892.32
584769-8476990.05890.90
677865-7786582.72483.54
极限185584-8558490.92489.882.1691.9190.862.14
287279-8727992.72593.70
382203-8220387.33288.31
483216-8321688.40989.38
585324-8532490.64891.64
684024-8402489.26790.23
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.949160591428920049175491775917130.24
210.899176591156914600.48
单位质量响应值RSD%判断
8383.278398.530.13数据可信
供试品溶液-25050702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%
5min167341-6734171.86874.852.3871.8774.862.38
270209-7020974.92974.93
369861-6986174.55874.56
469885-6988574.58374.58
572289-7228977.14977.15
671250-7125076.04076.04
10min176196-7619681.31983.972.0381.4484.102.03
279740-7974085.10185.23
380327-8032785.72785.85
478714-7871484.00684.13
577421-7742182.62682.75
679710-7971085.06985.20
15min182636-8263688.19185.173.4588.4585.443.44
279979-7997985.35685.62
379956-7995685.33185.60
482292-8229287.82488.09
578937-7893784.24484.51
675026-7502680.07080.34
20min178140-7814083.39386.993.1583.8087.403.14
279406-7940684.74485.15
384151-8415189.80890.22
483465-8346589.07689.49
583665-8366589.29089.70
680246-8024685.64186.04
30min184233-8423389.89689.712.1790.4490.262.15
284325-8432589.99490.54
385576-8557691.32991.89
485397-8539791.13891.70
580558-8055885.97486.53
684275-8427589.94190.49
45min189104-8910495.09491.392.2195.7992.092.19
284374-8437490.04690.75
383929-8392989.57190.28
486320-8632092.12392.83
585158-8515890.88391.58
684905-8490590.61391.31
60min187291-8729193.15992.251.9994.0193.101.98
285561-8556191.31392.16
388221-8822194.15295.01
486231-8623192.02892.89
587747-8774793.64694.50
683556-8355689.17390.02
极限187346-8734693.21892.890.4394.2293.900.42
287490-8749093.37294.37
387095-8709592.95093.97
487041-8704192.89393.91
586805-8680592.64193.65
686479-8647992.29393.29
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.949230391802915889245691121918540.59
210.899235891489919240.67
单位质量响应值RSD%判断
8396.168441.140.38数据可信
供试品溶液-25050703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%
5min161661-6166165.59069.645.6765.5969.645.67
269420-6942073.84373.84
360184-6018464.01964.02
466614-6661470.85870.86
566610-6661070.85470.85
668321-6832172.67472.67
10min172742-7274277.37780.172.6377.4980.282.63
276966-7696681.87081.99
376103-7610380.95281.06
477667-7766782.61682.73
573280-7328077.94978.07
675428-7542880.23480.36
15min179653-7965384.72884.521.6584.9784.771.64
278148-7814883.12783.39
381329-8132986.51186.75
479901-7990184.99285.25
577769-7776982.72482.97
679943-7994385.03785.29
20min176850-7685081.74785.652.5482.1386.042.53
281207-8120786.38186.78
382624-8262487.88988.27
480270-8027085.38585.78
580148-8014885.25585.64
682021-8202187.24787.64
30min181876-8187687.09386.741.4387.6187.271.42
279276-7927684.32784.87
382474-8247487.72988.26
481721-8172186.92887.47
581566-8156686.76387.29
682345-8234587.59288.13
45min179567-7956784.63787.763.5085.3088.443.47
285083-8508390.50491.19
384168-8416889.53190.21
478271-7827183.25883.94
583152-8315288.45089.12
684757-8475790.15790.85
60min185060-8506090.48088.712.8491.2889.532.81
285973-8597391.45192.28
382620-8262087.88488.71
479228-7922884.27685.10
583326-8332688.63589.46
684150-8415089.51290.35
极限185843-8584391.31388.762.2092.2789.732.17
283588-8358888.91489.90
381992-8199287.21688.19
485411-8541190.85391.82
581580-8158086.77887.75
682217-8221787.45688.44
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.948910489377887278878088933889840.30
210.898929589162892280.11
单位质量响应值RSD%判断
8133.828193.570.52数据可信
供试品溶液-25050704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%
5min167560-6756074.11076.432.8474.1176.432.84
268467-6846775.10475.10
371808-7180878.76978.77
468538-6853875.18275.18
572424-7242479.44579.45
669247-6924775.96075.96
10min177628-7762885.15485.051.1885.2885.181.18
276758-7675884.19984.32
378799-7879986.43886.57
476984-7698484.44784.57
578421-7842186.02386.16
676614-7661484.04184.17
15min177701-7770185.23485.535.0585.5085.805.04
277980-7798085.54085.81
381971-8197189.91890.19
476899-7689984.35484.62
581960-8196089.90690.18
671322-7132278.23678.50
20min179390-7939087.08687.744.2587.4988.154.24
273761-7376180.91281.32
383142-8314291.20291.63
481802-8180289.73290.14
582245-8224590.21890.64
679558-7955887.27187.67
30min183320-8332091.39789.982.5491.9590.532.54
279787-7978787.52288.06
383190-8319091.25591.83
484397-8439792.57993.13
582252-8225290.22690.80
679213-7921386.89287.43
45min188012-8801296.54492.922.2097.2593.632.18
284114-8411492.26892.96
384432-8443292.61793.35
482269-8226990.24590.95
584718-8471892.93193.66
684729-8472992.94393.63
60min187066-8706695.50790.237.2596.3791.107.19
284431-8443192.61693.46
382834-8283490.86491.75
485212-8521293.47394.33
583541-8354191.64092.52
670468-7046877.29978.14
极限186139-8613994.49092.853.3095.5193.863.27
285701-8570194.00995.01
388477-8847797.05498.09
480320-8032088.10789.12
583421-8342191.50892.54
683808-8380891.93392.90
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