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%
111.308173981535816168169281818816800.14
211.288123381222812280.01
单位质量响应值RSD%判断
7228.327201.060.27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%
10min127398-2739834.00736.8514.2734.0136.8514.27
224369-2436930.24730.25
335743-3574344.36544.36
433724-3372441.85941.86
528225-2822535.03335.03
628656-2865635.56835.57
15min149250-4925061.13065.343.9361.5165.753.91
253583-5358366.50866.84
353377-5337766.25366.75
452561-5256165.24065.70
551718-5171864.19464.58
655383-5538368.74369.14
30min154527-5452767.68069.822.5168.7470.962.56
254774-5477467.98769.06
357541-5754171.42172.65
457940-5794071.91673.11
556710-5671070.39071.49
656018-5601869.53170.69
45min158252-5825272.30476.904.0974.1178.814.04
261302-6130276.08977.92
364242-6424279.73981.76
459974-5997474.44176.43
564442-6444279.98781.87
663532-6353278.85780.79
60min160197-6019774.71878.362.8177.3381.122.85
261822-6182276.73579.41
364886-6488680.53883.45
464198-6419879.68482.50
563535-6353578.86181.63
664129-6412979.59882.41
90min162517-6251777.59783.383.7081.0487.023.66
266714-6671482.80786.34
368165-6816584.60888.41
467365-6736583.61587.32
568903-6890385.52489.17
669388-6938886.12689.82
120min164597-6459780.17984.273.2884.4888.833.26
267735-6773584.07488.52
371385-7138588.60593.35
468856-6885685.46690.10
567622-6762283.93488.53
667146-6714683.34387.99
极限162554-6255477.64383.763.7982.8489.263.72
267805-6780584.16189.54
368168-6816884.61290.34
469822-6982286.66592.24
567554-6755483.84989.38
668973-6897385.61191.19
布瑞哌唑口服混悬液项目信息
介质体积(ml)900.取样体积(ml)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%
111.308138581087813718079281132811530.30
211.288095980858809080.09
单位质量响应值RSD%判断
7181.687172.700.09数据可信
供试品溶液-25090902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%
10min121610-2161026.96328.7126.6726.9628.7126.68
221950-2195027.38727.39
322599-2259928.19728.20
432842-3284240.97740.98
513866-1386617.30117.30
625197-2519731.43831.44
15min156822-5682270.89766.973.6871.2067.293.69
255154-5515468.81669.12
352139-5213965.05465.37
453522-5352266.78067.23
551635-5163564.42564.62
652768-5276865.83966.19
30min164311-6431180.24177.742.2181.3378.812.13
262566-6256678.06479.13
361812-6181277.12378.16
461293-6129376.47577.67
563311-6331178.99379.90
660563-6056375.56576.65
45min169321-6932186.49283.202.9788.4785.122.98
266860-6686083.42185.36
367393-6739384.08685.98
467414-6741484.11386.16
563452-6345279.16980.96
665635-6563581.89383.81
60min170444-7044487.89384.244.5590.8387.104.52
268564-6856485.54888.41
367470-6747084.18387.01
470853-7085388.40491.39
563656-6365679.42482.09
664128-6412880.01382.84
90min174326-7432692.73790.531.8196.6594.321.80
272637-7263790.62994.44
372992-7299291.07294.84
472526-7252690.49194.45
572607-7260790.59294.14
670257-7025787.66091.38
120min176596-7659695.56991.674.14100.5296.464.08
273692-7369291.94696.77
375081-7508193.67998.45
475941-7594194.75299.72
569964-6996487.29491.85
669559-6955986.78991.48
极限177499-7749996.69693.262.39102.7099.082.37
276442-7644295.377101.22
374203-7420392.58398.40
473692-7369291.94697.97
573240-7324091.38296.91
673414-7341491.59997.26
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%
111.308086381379809398063880987809610.34
211.288096680846809060.11
单位质量响应值RSD%判断
7164.697172.520.08数据可信
供试品溶液-25090903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%
10min134228-3422842.75837.8814.9942.7637.8814.99
229882-2988237.32937.33
333461-3346141.79941.80
433193-3319341.46541.46
529088-2908836.33736.34
622070-2207027.57027.57
15min151745-5174564.64064.453.0165.1164.873.02
250582-5058263.18763.60
350879-5087963.55864.02
451884-5188464.81365.27
554422-5442267.98468.39
650056-5005662.53062.84
30min160147-6014775.13573.142.5276.3374.282.55
257825-5782572.23573.35
358352-5835272.89374.06
457816-5781672.22473.40
560486-6048675.55976.72
656690-5669070.81771.82
45min163904-6390479.82979.392.8881.8681.342.84
265358-6535881.64583.56
361761-6176177.15279.13
465946-6594682.38084.36
562709-6270978.33680.33
661646-6164677.00878.80
60min166061-6606182.52381.772.5685.4484.612.52
265782-6578282.17585.00
362549-6254978.13680.97
467601-6760184.44787.35
565857-6585782.26885.14
664918-6491881.09583.74
90min168807-6880785.95485.610.9189.7989.340.95
268798-6879885.94289.68
367506-6750684.32888.03
468698-6869885.81789.65
569249-6924986.50690.29
668113-6811385.08788.63
120min171150-7115088.88086.083.3693.6790.773.24
269602-6960286.94791.64
365533-6553381.86486.51
471338-7133889.11593.91
566924-6692483.60188.35
668884-6888486.05090.54
极限170552-7055288.13382.8410.2393.9188.489.64
266324-6632482.85288.51
352805-5280565.96471.52
469924-6992487.34993.13
569670-6967087.03292.70
668594-6859485.68791.13
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