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%
111.339794797798977679786797878978510.08
211.299789697964979300.05
单位质量响应值RSD%判断
8636.458674.050.31数据可信
供试品溶液-25062301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%
10min156774-5677458.74055.067.5658.7455.067.56
256137-5613758.08158.08
354238-5423856.11756.12
454887-5488756.78856.79
551294-5129453.07153.07
646000-4600047.59347.59
15min163983-6398366.19964.634.0166.5364.943.98
261969-6196964.11564.44
361904-6190464.04864.36
458452-5845260.47760.79
562494-6249464.65964.95
665986-6598668.27268.54
20min171017-7101773.47769.673.9774.1770.333.94
267448-6744869.78470.46
362764-6276464.93865.61
468429-6842970.79971.45
567188-6718869.51570.17
667154-6715469.48070.12
30min173679-7367976.23173.114.2577.3374.164.20
269791-6979172.20873.27
366391-6639168.69169.72
473136-7313675.66976.71
568189-6818970.55171.59
672810-7281075.33276.36
45min174799-7479977.39073.734.0878.9275.194.05
269664-6966472.07773.54
366972-6697269.29270.70
474033-7403376.59778.06
570358-7035872.79574.23
671766-7176674.25275.70
60min175713-7571378.33575.854.8280.2977.724.75
273328-7332875.86877.74
366337-6633768.63570.43
475249-7524977.85579.75
574115-7411576.68278.52
675151-7515177.75479.61
极限177241-7724179.91675.433.5982.3177.723.56
271700-7170074.18376.47
369468-6946871.87474.05
471873-7187374.36276.69
573330-7333075.87078.13
673823-7382376.38078.67
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%
111.339789797795979429784498021979000.09
211.299854198306984240.17
单位质量响应值RSD%判断
8640.788717.800.63数据可信
供试品溶液-25062301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%
10min153500-5350055.20153.164.7155.2053.164.71
251539-5153953.17753.18
352212-5221253.87253.87
453874-5387455.58655.59
550836-5083652.45252.45
647159-4715948.65848.66
15min158281-5828160.13463.536.6860.4463.836.64
263667-6366765.69165.99
366912-6691269.03969.34
460074-6007461.98462.29
556073-5607357.85558.15
664451-6445166.50066.77
20min167809-6780969.96470.652.0470.6171.302.03
269931-6993172.15472.81
369340-6934071.54472.23
466061-6606168.16168.81
568447-6844770.62371.24
669246-6924671.44772.09
30min168661-6866170.84472.363.2871.8773.403.25
272631-7263174.94076.00
372362-7236274.66275.74
466974-6697469.10370.13
571300-7130073.56674.57
668871-6887171.06072.10
45min170078-7007872.30674.893.5573.7376.333.52
273796-7379676.14277.62
376598-7659879.03380.53
469898-6989872.12073.54
573559-7355975.89777.31
671563-7156373.83875.27
60min173030-7303075.35178.308.0577.1880.157.91
286938-8693889.70191.60
378299-7829980.78882.72
469722-6972271.93873.75
574770-7477077.14778.98
672545-7254574.85176.69
极限173539-7353975.87776.101.3178.1278.401.26
274047-7404776.40178.80
372555-7255574.86177.24
472968-7296875.28777.50
575252-7525277.64479.91
674191-7419176.54978.81
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%
111.339783197761979099773298017978500.12
211.299765397676976640.02
单位质量响应值RSD%判断
8636.368650.490.12数据可信
供试品溶液-25062302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%
10min149653-4965351.44351.286.9851.4451.286.98
244100-4410045.69045.69
354964-5496456.94556.95
449798-4979851.59351.59
548869-4886950.63150.63
649567-4956751.35451.35
15min164144-6414466.45665.684.6066.7465.974.58
266532-6653268.93069.18
365736-6573668.10668.42
459228-5922861.36361.65
564269-6426966.58666.87
660486-6048662.66662.95
20min161728-6172863.95369.814.7964.6170.464.74
269965-6996572.48773.12
369201-6920171.69672.39
467367-6736769.79570.42
565874-6587468.24968.90
670174-7017472.70473.34
30min166050-6605068.43174.004.3869.4475.044.34
273368-7336876.01377.05
372032-7203274.62975.72
471312-7131273.88374.90
570503-7050373.04574.07
675299-7529978.01379.05
45min162204-6220464.44673.186.9965.8474.636.90
270786-7078673.33874.80
374026-7402676.69578.20
469253-6925371.74973.18
570788-7078873.34074.78
676724-7672479.49080.96
60min156085-5608558.10774.2611.2759.8676.1211.07
275910-7591078.64680.52
373881-7388176.54478.48
471127-7112773.69175.52
574025-7402576.69378.54
679053-7905381.90383.82
极限165049-6504967.39477.106.3869.4779.376.32
276189-7618978.93581.24
377565-7756580.36182.72
474859-7485977.55879.79
575163-7516377.87280.14
677708-7770880.50982.88
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%
111.339747697630973759745297615975100.12
211.299784397408976260.32
单位质量响应值RSD%判断
8606.358647.120.34数据可信
供试品溶液-25062302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%
10min151577-5157753.54050.3111.2853.5450.3011.29
251736-5173653.70553.70
348734-4873450.58950.59
450845-5084552.78052.78
537526-3752638.95438.95
650358-5035852.27452.27
15min159363-5936361.62262.914.2361.9263.194.25
261268-6126863.60063.90
358231-5823160.44760.73
463795-6379566.22366.52
557738-5773859.93560.15
663217-6321765.62365.91
20min165453-6545367.94468.323.3868.5868.943.39
263515-6351565.93266.58
366193-6619368.71269.33
467728-6772870.30670.97
563218-6321865.62466.17
668763-6876371.38072.03
30min169077-6907771.70672.214.0872.7273.224.09
271341-7134174.05675.07
369124-6912471.75572.75
470641-7064173.32974.38
564500-6450066.95567.87
672682-7268275.44876.50
45min169397-6939772.03872.616.9973.4574.026.94
273255-7325576.04377.47
371176-7117673.88575.28
470089-7008972.75674.22
560871-6087163.18864.47
674877-7487777.72779.20
60min172071-7207174.81475.393.6076.6377.213.63
275330-7533078.19780.05
371785-7178574.51776.32
471976-7197674.71576.58
568757-6875771.37473.01
675856-7585678.74380.65
极限168210-6821070.80674.025.3573.0476.265.28
275603-7560378.48080.77
366356-6635668.88171.10
473060-7306075.84078.12
569569-6956972.21774.25
675051-7505177.90780.25
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