布瑞派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%
111.098077580430803598037480456804790.22
211.128033880631804840.26
单位质量响应值RSD%判断
7256.907237.770.19数据可信
供试品溶液-2025091551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
15min1-0.0003.2179.310.003.2179.30
23819-38194.7194.72
34003-40034.9464.95
44584-45845.6645.66
5-0.0000.00
63196-31963.9493.95
20min14095-40955.0606.8814.365.066.9214.50
25213-52136.4416.49
35907-59077.2997.35
46140-61407.5877.65
55941-59417.3417.34
66134-61347.5797.62
30min13036-30363.7518.3428.553.818.4628.47
26482-64828.0098.13
37082-70828.7518.89
47990-79909.87310.02
57733-77339.5559.64
68198-819810.13010.26
45min15080-50806.2779.8018.346.3710.0018.51
27757-77579.5859.80
38498-849810.50010.73
48622-862210.65410.91
58635-863510.67010.86
68990-899011.10811.35
60min13367-33674.1609.8831.224.3310.1930.93
27023-70238.6789.00
38561-856110.57810.93
49610-961011.87412.25
59591-959111.85112.16
69805-980512.11512.48
极限15904-59047.29511.4618.637.5111.8818.84
29718-971812.00812.42
39110-911011.25711.72
410367-1036712.81013.32
59967-996712.31612.75
610562-1056213.05113.55
布瑞派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%
111.098042780497805488031080305804170.14
211.127998180214800980.21
单位质量响应值RSD%判断
7251.317203.060.48数据可信
供试品溶液-2025091551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
15min13160-31603.9165.7919.653.925.7919.62
24084-40845.0605.06
34730-47305.8615.86
45394-53946.6846.68
55015-50156.2146.21
65640-56406.9886.99
20min13717-37174.6067.8421.214.657.9021.18
26119-61197.5827.64
37251-72518.9859.05
47200-72008.9219.00
56918-69188.5728.64
66748-67488.3618.44
30min16699-66998.3019.737.878.409.888.02
27761-77619.6179.76
37842-78429.7179.88
48408-840810.41810.59
58082-808210.01410.18
68308-830810.29410.46
45min15606-56066.94610.0515.837.1310.3015.81
28110-811010.04910.30
38210-821010.17310.45
49068-906811.23611.53
58739-873910.82811.10
68909-890911.03911.32
60min15563-55636.89310.8619.377.1611.2319.18
28310-831010.29710.66
310356-1035612.83213.22
49496-949611.76612.18
59465-946511.72812.12
69378-937811.62012.03
极限14579-45795.67410.1723.926.0110.6623.55
27555-75559.3619.83
38455-845510.47611.01
49320-932011.54812.09
59403-940311.65112.18
69918-991812.28912.83
布瑞派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%
111.098026180627802658042380077803310.26
211.128017380042801080.12
单位质量响应值RSD%判断
7243.557203.960.39数据可信
供试品溶液-2025091551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%
10min144430-4443055.07950.425.7355.0850.425.73
241685-4168551.67651.68
341027-4102750.86050.86
439377-3937748.81448.81
539926-3992649.49549.50
637575-3757546.58146.58
15min163198-6319878.34576.151.9278.9676.711.94
260137-6013774.55075.12
361989-6198976.84677.41
461057-6105775.69076.23
561939-6193976.78477.33
660246-6024674.68575.20
20min166584-6658482.54280.262.0284.0281.672.02
265052-6505280.64382.05
365028-6502880.61382.03
462615-6261577.62279.01
564995-6499580.57281.98
664178-6417879.55980.91
30min171923-7192389.16185.302.3691.5687.602.35
268230-6823084.58386.88
368479-6847984.89187.21
467323-6732383.45885.70
567958-6795884.24586.54
668962-6896285.49087.72
45min174109-7410991.87188.832.1695.2692.082.15
271968-7196889.21792.45
372662-7266290.07793.33
470432-7043287.31290.49
570338-7033887.19690.43
670427-7042787.30690.49
60min175361-7536193.42389.122.6497.8393.362.62
271390-7139088.50092.73
372296-7229689.62393.88
469790-6979086.51790.66
570851-7085187.83292.04
671673-7167388.85193.00
极限170223-7022387.05387.211.6192.5092.431.51
269649-6964986.34291.55
369799-6979986.52891.78
468990-6899085.52590.63
571642-7164288.81293.99
671776-7177688.97994.12
布瑞派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%
111.098022380330801738017480248802300.09
211.127999880142800700.13
单位质量响应值RSD%判断
7234.457200.540.34数据可信
供试品溶液-2025091551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%
10min143361-4336153.80052.645.0153.8052.645.01
244559-4455955.28655.29
344837-4483755.63155.63
440989-4098950.85750.86
541183-4118351.09751.10
639646-3964649.19049.19
15min161555-6155576.37475.612.0176.9776.192.00
259225-5922573.48374.10
362788-6278877.90478.52
461288-6128876.04376.61
560417-6041774.96275.53
660343-6034374.87075.42
20min165637-6563781.43981.971.0382.8883.401.04
265656-6565681.46282.89
367127-6712783.28784.77
466707-6670782.76684.18
565799-6579981.64083.04
665486-6548681.25182.63
30min169779-6977986.57886.351.7288.9388.681.71
268355-6835584.81187.15
371406-7140688.59691.01
470467-7046787.43189.76
569043-6904385.66587.97
668514-6851485.00887.29
45min174059-7405991.88889.552.3395.2092.842.31
271902-7190289.21292.49
374214-7421492.08095.47
471880-7188089.18592.49
571041-7104188.14491.40
669943-6994386.78190.01
60min174271-7427192.15190.103.5696.4994.393.48
273532-7353291.23495.50
375536-7553693.72198.14
472708-7270890.21294.50
571502-7150288.71692.95
668147-6814784.55388.74
极限172620-7262090.10390.631.5295.4695.921.54
273763-7376391.52196.80
374768-7476892.76898.23
473204-7320490.82796.12
572087-7208789.44194.67
671811-7181189.09994.23
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