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%
111.219449294391943619427094226943480.12
211.279462994604946160.02
单位质量响应值RSD%判断
8416.418395.390.18数据可信
供试品溶液-25061901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%
10min163472-6347267.61866.311.4467.6266.311.44
262064-6206466.11866.12
363012-6301267.12867.13
461762-6176265.79765.80
560975-6097564.95864.96
662184-6218466.24666.25
15min176850-7685081.87079.412.9181.9879.522.90
272342-7234277.06877.18
375837-7583780.79180.90
473195-7319577.97678.09
572298-7229877.02177.13
676720-7672081.73281.84
30min177176-7717682.21883.012.5182.4783.262.50
279778-7977884.98985.23
375773-7577380.72380.97
475765-7576580.71480.95
578975-7897584.13484.37
680079-8007985.31085.56
45min183125-8312588.55589.171.3088.9489.551.29
283538-8353888.99589.38
385407-8540790.98691.37
483550-8355089.00889.38
582246-8224687.61988.00
684352-8435289.86290.25
60min185231-8523190.79990.123.8691.3390.653.84
285674-8567491.27191.80
382788-8278888.19688.73
478953-7895384.11184.63
587365-8736593.07293.59
687550-8755093.26993.81
90min187559-8755993.27992.472.1493.9693.152.13
283745-8374589.21689.90
388135-8813593.89294.57
485790-8579091.39492.06
588911-8891194.71995.40
686657-8665792.31893.01
120min188036-8803693.78793.391.4794.6394.231.46
285614-8561491.20792.04
389508-8950895.35596.19
487198-8719892.89493.71
587495-8749593.21194.05
688131-8813193.88894.74
极限1-0.0000.00-1.000.991.28
2-0.0000.98
3-0.0001.00
4-0.0000.97
5-0.0000.99
6-0.0001.00
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%
111.219452594596945479444594511945250.06
211.279445494431944420.02
单位质量响应值RSD%判断
8432.208379.950.44数据可信
供试品溶液-25061901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
15min11749-17491.8631.4881.111.861.4881.10
22207-22072.3512.35
31729-17291.8421.84
4-0.0000.00
5-0.0000.00
62633-26332.8052.80
30min115136-1513616.12512.4118.3716.1312.4118.39
29864-986410.50810.51
310515-1051511.20211.20
412327-1232713.13213.13
59436-943610.05210.05
612591-1259113.41313.42
45min110107-1010710.76712.8110.9510.8012.8310.91
211575-1157512.33112.35
311851-1185112.62512.65
412239-1223913.03813.06
512182-1218212.97812.99
614186-1418615.11315.14
60min119043-1904320.28715.8117.1620.3315.8517.11
216171-1617117.22717.27
314591-1459115.54415.59
411976-1197612.75812.80
512692-1269213.52113.56
614566-1456615.51715.57
90min112632-1263213.45718.6515.5513.5418.7215.46
219262-1926220.52020.59
318974-1897420.21320.28
420215-2021521.53521.60
517225-1722518.35018.41
616729-1672917.82217.90
120min130006-3000631.96625.0727.2432.0725.1727.14
218095-1809519.27719.38
325862-2586227.55127.65
431499-3149933.55633.66
518551-1855119.76319.85
617187-1718718.31018.42
极限117269-1726918.39723.4421.6918.5523.5821.58
217365-1736518.49918.64
327869-2786929.68929.84
427349-2734929.13529.29
519463-1946320.73420.86
622698-2269824.18024.32
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%
111.219432694348943039424494239942920.06
211.279477994769947740.01
单位质量响应值RSD%判断
8411.428409.410.02数据可信
供试品溶液-25061901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%
10min153904-5390457.39456.466.4157.3956.466.41
251951-5195155.31555.31
349826-4982653.05253.05
449322-4932252.51652.52
558387-5838762.16862.17
654759-5475958.30558.30
15min157597-5759761.32762.383.6961.4262.473.69
257246-5724660.95361.04
355568-5556859.16659.25
459983-5998363.86763.95
559659-5965963.52263.63
661473-6147365.45365.55
30min165472-6547269.71170.582.0669.9170.782.06
267392-6739271.75671.95
363996-6399668.14068.33
467427-6742771.79371.99
567196-6719671.54771.76
666239-6623970.52870.73
45min171903-7190376.55977.101.5476.8777.411.54
273310-7331078.05778.37
371217-7121775.82876.13
474206-7420679.01179.32
571891-7189176.54676.87
671934-7193476.59276.92
60min176055-7605580.98081.141.3781.4281.591.37
275813-7581380.72281.17
374783-7478379.62580.05
477987-7798783.03783.48
576272-7627281.21181.67
676345-7634581.28881.74
90min179328-7932884.46588.7410.1985.0489.3210.12
2100513-100513107.021107.60
378951-7895184.06384.62
482013-8201387.32387.91
579122-7912284.24584.84
680151-8015185.34185.93
120min181907-8190787.21187.431.2887.9388.161.27
281766-8176687.06087.82
381673-8167386.96187.66
484162-8416289.61290.34
582037-8203787.34988.08
681139-8113986.39387.12
极限183378-8337888.77788.980.8789.6489.850.87
283524-8352488.93289.83
382672-8267288.02588.87
484861-8486190.35691.23
583260-8326088.65189.53
683723-8372389.14490.02
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