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%
111.219580795842959639588495477957950.20
211.279585095927958880.06
单位质量响应值RSD%判断
8545.508508.250.31数据可信
供试品溶液-25061301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%
10min166850-6685070.20773.836.8770.2173.836.87
276406-7640680.24380.24
373658-7365877.35777.36
466858-6685870.21570.22
573538-7353877.23177.23
664504-6450467.74367.74
15min169184-6918472.65880.065.7472.7880.195.74
280922-8092284.98585.12
376340-7634080.17380.30
479518-7951883.51183.63
578232-7823282.16082.29
673211-7321176.88777.00
30min171106-7110674.67783.068.0474.9183.318.03
287338-8733891.72492.00
385019-8501989.28889.55
476902-7690280.76481.02
580388-8038884.42584.69
673754-7375477.45777.70
45min170953-7095374.51684.557.7174.8884.957.70
287925-8792592.34092.77
385938-8593890.25390.66
476722-7672280.57580.97
581795-8179585.90286.31
679733-7973383.73784.11
60min169675-6967573.17485.918.4373.6686.458.42
288606-8860693.05593.64
387243-8724391.62492.19
479441-7944183.43083.96
584729-8472988.98489.53
681145-8114585.22085.73
90min167321-6732170.70185.8010.0171.3186.489.98
290727-9072795.28396.02
387348-8734891.73492.45
479343-7934383.32783.99
580936-8093685.00085.70
684539-8453988.78489.44
120min164120-6412067.34084.0712.6168.0784.8912.55
289978-8997894.49695.39
387195-8719591.57392.44
471533-7153375.12575.93
585438-8543889.72890.57
682036-8203686.15586.96
极限1-0.0000.00-0.840.967.83
2-0.0001.05
3-0.0001.02
4-0.0000.93
5-0.0000.99
6-0.0000.94
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%
111.219608795942957989575095675958500.18
211.279613796258961980.09
单位质量响应值RSD%判断
8550.408535.760.13数据可信
供试品溶液-25061302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%
10min141420-4142043.41753.6210.3843.4253.6210.38
253174-5317455.73855.74
357315-5731560.07960.08
450230-5023052.65252.65
552250-5225054.76954.77
652548-5254855.08255.08
15min160546-6054663.46570.815.8163.5470.905.81
266153-6615369.34369.44
371973-7197375.44375.54
468873-6887372.19472.28
569585-6958572.94073.03
668186-6818671.47471.57
30min170876-7087674.29378.233.3074.4778.433.31
275129-7512978.75278.96
378212-7821281.98382.21
473650-7365077.20177.41
575911-7591179.57179.78
673985-7398577.55277.76
45min169052-6905272.38281.925.8272.6882.265.82
280171-8017184.03784.38
378948-7894882.75583.12
481375-8137585.29985.64
579058-7905882.87083.22
680311-8031184.18384.52
60min174597-7459778.19486.035.4378.6286.505.43
278989-7898982.79883.28
384371-8437188.43988.94
483112-8311287.11987.60
586576-8657690.75091.23
684765-8476588.85289.33
90min175529-7552979.17187.294.6679.7287.914.66
285615-8561589.74390.36
384631-8463188.71289.36
485503-8550389.62690.25
584926-8492689.02189.66
683447-8344787.47188.10
120min180855-8085584.75488.562.7885.4489.322.80
284803-8480388.89289.66
387420-8742091.63592.43
484200-8420088.26089.03
586455-8645590.62491.41
683197-8319787.20987.98
极限1-0.0000.00-0.830.914.58
2-0.0000.92
3-0.0000.95
4-0.0000.92
5-0.0000.93
6-0.0000.92
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%
111.219593796076965419634196271962330.25
211.279631796542964300.17
单位质量响应值RSD%判断
8584.578556.340.24数据可信
供试品溶液-25061301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%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min12893-28933.0234.6044.133.024.6044.18
25254-52545.4905.49
37537-75377.8757.88
45141-51415.3725.37
52468-24682.5792.58
63093-30933.2323.23
30min117035-1703517.79916.6914.2917.8016.7014.30
215414-1541416.10616.11
318681-1868119.51919.53
417844-1784418.64518.65
514123-1412314.75714.76
612756-1275613.32813.33
45min121076-2107622.02220.7610.9222.0620.7910.93
217599-1759918.38918.42
322045-2204523.03423.08
422224-2222423.22123.26
518644-1864419.48119.51
617608-1760818.39818.43
60min123818-2381824.88725.465.9624.9625.535.96
222980-2298024.01124.08
326528-2652827.71827.80
425574-2557426.72226.80
522897-2289723.92423.99
624396-2439625.49125.55
90min125050-2505026.17425.569.4326.2925.689.42
223759-2375924.82524.93
323987-2398725.06325.19
428782-2878230.07330.20
522672-2267223.68923.79
622554-2255423.56623.67
120min125898-2589827.06026.727.8227.2226.887.82
226077-2607727.24727.40
327299-2729928.52428.70
427779-2777929.02529.20
523701-2370124.76424.91
622699-2269923.71823.86
极限128938-2893830.23627.666.1430.4427.866.09
226046-2604627.21527.41
325308-2530826.44426.66
425801-2580126.95927.18
524786-2478625.89826.08
627981-2798129.23729.42
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%
111.219594896345955779604396048959920.29
211.279578495507956460.21
单位质量响应值RSD%判断
8563.078486.780.64数据可信
供试品溶液-25061302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%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0001.86154.990.001.86154.99
25201-52015.4635.46
3-0.0000.00
4-0.0000.00
55445-54455.7205.72
6-0.0000.00
30min110225-1022510.74111.5222.6810.7411.5222.71
211186-1118611.75111.76
39405-94059.8809.88
412023-1202312.63012.63
515108-1510815.87115.88
67863-78638.2608.26
45min111590-1159012.17513.306.6712.1913.326.69
213032-1303213.69013.72
313342-1334214.01514.03
413656-1365614.34514.37
512598-1259813.23413.27
611757-1175712.35012.36
60min113394-1339414.07014.079.2814.1114.129.24
213355-1335514.02914.08
312561-1256113.19513.23
415723-1572316.51716.56
512146-1214612.75912.82
613188-1318813.85413.89
90min111886-1188612.48615.5711.2012.5515.6411.17
215626-1562616.41516.49
315716-1571616.50916.57
416692-1669217.53417.61
514439-1443915.16815.25
614588-1458815.32415.38
120min114552-1455215.28617.5513.4115.3717.6513.34
215514-1551416.29716.40
320636-2063621.67821.77
418038-1803818.94819.05
515656-1565616.44616.55
615872-1587216.67316.76
极限115352-1535216.12718.618.1216.2318.738.09
217954-1795418.86018.99
317457-1745718.33818.46
418943-1894319.89920.03
517186-1718618.05318.19
619403-1940320.38220.49
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%
111.219643196575963249581695867962030.36
211.279667096643966560.02
单位质量响应值RSD%判断
8581.898576.400.05数据可信
供试品溶液-25061301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%
10min124587-2458725.66452.5125.7325.6652.5025.74
260542-6054263.19463.19
356396-5639658.86758.87
451676-5167653.94053.94
554703-5470357.10057.10
653905-5390556.26756.27
15min132345-3234533.76258.4722.1533.8058.5622.16
267131-6713170.07270.18
363939-6393966.74066.84
455915-5591558.36558.45
560821-6082163.48663.58
655949-5594958.40058.49
30min149708-4970851.88667.3513.4151.9867.5313.43
270445-7044573.53173.75
369863-6986372.92473.13
471528-7152874.66274.85
567037-6703769.97470.17
658556-5855661.12161.31
45min156024-5602458.47871.2414.1658.6671.5414.16
278662-7866282.10882.45
371369-7136974.49674.83
472374-7237475.54575.86
574674-7467477.94678.26
656393-5639358.86459.16
60min163060-6306065.82375.6410.0566.1176.0610.08
279700-7970083.19283.67
378691-7869182.13882.59
474152-7415277.40177.84
575363-7536378.66579.11
663842-6384266.63967.03
90min167977-6797770.95577.977.6471.3578.527.68
281717-8171785.29785.92
379706-7970683.19883.79
474590-7459077.85878.42
575957-7595779.28579.86
668258-6825871.24871.75
120min165626-6562668.50181.329.2669.0182.009.30
284961-8496188.68389.45
382588-8258886.20686.94
480118-8011883.62884.32
581028-8102884.57885.29
673140-7314076.34476.97
极限174366-7436677.62482.205.2378.2583.015.27
286218-8621889.99590.91
377294-7729480.68081.55
480313-8031383.83284.67
577341-7734180.72981.58
676997-7699780.37081.12
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