依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159438939436999437229424589438879435320.07
211.179410159419869415000.08
单位质量响应值RSD%判断
84621.7084288.270.28数据可信
供试品溶液-2024092721批-依折麦布-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%
5min134718-347183.6914.8514.113.694.8514.12
253441-534415.6815.68
348557-485575.1625.16
442519-425194.5204.52
546023-460234.8924.89
648631-486315.1695.17
10min167257-672577.1497.411.987.197.472.06
269847-698477.4257.49
370073-700737.4497.51
469581-695817.3967.45
571510-715107.6017.66
669978-699787.4397.50
15min171500-715007.6007.681.937.727.821.91
272616-726167.7197.86
374817-748177.9538.09
472220-722207.6777.81
571131-711317.5617.70
671188-711887.5677.71
20min171222-712227.5717.641.387.787.861.38
271165-711657.5657.80
373373-733737.8008.03
471248-712487.5747.79
572803-728037.7397.96
671208-712087.5697.79
30min170517-705177.4967.561.167.787.861.19
271050-710507.5537.87
372312-723127.6878.00
470258-702587.4687.77
570531-705317.4977.81
671821-718217.6357.94
45min170814-708147.5287.562.717.907.952.59
269125-691257.3487.75
372857-728577.7458.15
469352-693527.3727.76
570605-706057.5057.90
673950-739507.8618.25
60min170010-700107.4427.581.037.908.051.08
271514-715147.6028.08
371209-712097.5698.06
471055-710557.5538.02
572087-720877.6638.14
671839-718397.6368.12
极限169779-697797.4177.611.857.968.171.79
272815-728157.7408.31
370972-709727.5448.12
471169-711697.5658.12
573364-733647.7998.36
671189-711897.5678.13
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.162538722547942551412543452545272545360.19
210.192548792543072545930.16
单位质量响应值RSD%判断
25052.7624984.590.20数据可信
供试品溶液-2024092721批-贝派度酸-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%
5min13028-30281.2071.6918.931.211.6918.88
25076-50762.0232.02
34939-49391.9691.97
43595-35951.4331.43
54203-42031.6751.68
64634-46341.8471.85
10min17503-75032.9913.023.343.003.043.39
27961-79613.1733.20
37215-72152.8762.90
47616-76163.0363.05
57437-74372.9642.98
67695-76953.0673.09
15min18346-83463.3273.303.103.373.363.07
28719-87193.4753.53
38381-83813.3413.39
48054-80543.2103.26
58020-80203.1973.25
68214-82143.2743.33
20min18387-83873.3433.371.723.433.461.77
28562-85623.4133.51
38299-82993.3083.40
48269-82693.2963.38
58609-86093.4313.52
68542-85423.4053.50
30min18567-85673.4153.441.543.543.561.39
28422-84223.3573.49
38761-87613.4923.62
48762-87623.4923.61
58555-85553.4103.54
68656-86563.4503.58
45min18151-81513.2493.342.173.413.502.12
28478-84783.3793.55
38274-82743.2983.46
48470-84703.3763.54
58265-82653.2943.46
68645-86453.4463.61
60min18285-82853.3023.362.483.503.562.33
28503-85033.3893.60
38341-83413.3253.53
48669-86693.4553.65
58145-81453.2463.45
68641-86413.4443.65
极限17966-79663.1753.144.503.413.384.13
27669-76693.0573.30
38040-80403.2053.44
48477-84773.3793.62
57557-75573.0123.25
67583-75833.0223.27
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