贝派度酸依折麦布片项目信息
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%
111.159721709735889724319726419715609724780.08
211.179675079645329660200.22
单位质量响应值RSD%判断
87217.7686483.440.60数据可信
供试品溶液-2024092721批-依折麦布-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1205904-20590421.28430.0235.4921.2830.0235.49
2252762-25276226.12826.13
3377351-37735139.00639.01
4364697-36469737.69837.70
5146926-14692615.18815.19
6394698-39469840.80040.80
10min1525103-52510354.27970.7227.5454.5271.0627.57
2582206-58220660.18260.47
3893698-89369892.38192.81
4834400-83440086.25186.67
5447189-44718946.22546.39
6822412-82241285.01285.47
15min1720305-72030574.45789.0410.8175.3090.1610.99
2794157-79415782.09183.05
3947746-94774697.96899.43
4946530-94653097.84299.22
5837946-83794686.61887.30
6921720-92172095.27796.68
20min1824032-82403285.17990.479.5186.8592.589.69
2893334-89333492.34394.21
3938873-93887397.05099.60
4945206-94520697.705100.17
5731132-73113275.57677.22
6918967-91896794.99397.45
30min1873682-87368290.31292.666.1092.9295.776.35
2916985-91698594.78897.68
3951856-95185698.392102.02
4935144-93514496.665100.21
5799433-79943382.63785.12
6901316-90131693.16896.68
45min1888781-88878191.87293.124.6995.4997.275.01
2908362-90836293.89697.85
3945035-94503597.687102.41
4930289-93028996.163100.79
5824373-82437385.21588.62
6908313-90831393.89198.44
60min1880544-88054491.02192.823.3795.6698.003.70
2920600-92060095.162100.16
3915102-91510294.593100.40
4930311-93031196.165101.86
5849132-84913287.77492.12
6891859-89185992.19197.78
极限1906097-90609793.66293.412.1799.3199.622.37
2921735-92173595.279101.33
3917809-91780994.873101.73
4917790-91779094.871101.63
5878029-87802990.76196.09
6880751-88075191.04297.66
贝派度酸依折麦布片项目信息
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%
110.162598202596412589672602522592442595850.20
210.192573292576762575020.10
单位质量响应值RSD%判断
25549.7025270.070.78数据可信
供试品溶液-2024092721批-贝派度酸-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min127152-2715210.65616.9734.6110.6616.9734.60
240436-4043615.86915.87
355284-5528421.69721.70
454325-5432521.32021.32
524161-241619.4829.48
658093-5809322.79922.80
10min185953-8595333.73343.1725.9833.8543.3626.01
295463-9546337.46537.64
3138860-13886054.49754.74
4133236-13323652.28952.53
573040-7304028.66528.77
6133512-13351252.39852.65
15min1127995-12799550.23360.7811.1350.7361.4411.26
2141765-14176555.63756.23
3167793-16779365.85266.70
4169487-16948766.51667.33
5152869-15286959.99560.42
6169250-16925066.42367.26
20min1156766-15676661.52466.4810.1362.5867.8210.27
2169690-16969066.59667.81
3180489-18048970.83472.41
4183775-18377572.12473.68
5141642-14164255.58856.68
6183930-18393072.18573.76
30min1185493-18549372.79875.566.1074.5377.646.32
2193173-19317375.81277.76
3203266-20326679.77382.14
4201303-20130379.00381.36
5172552-17255267.71969.43
6199452-19945278.27680.65
45min1209152-20915282.08382.924.4984.6385.844.73
2208127-20812781.68184.47
3219327-21932786.07789.33
4216392-21639284.92588.16
5194815-19481576.45778.92
6219845-21984586.28089.53
60min1217346-21734685.29987.152.7088.7591.003.01
2222314-22231487.24990.95
3224492-22449288.10492.31
4227393-22739389.24293.42
5212779-21277983.50786.82
6228086-22808689.51493.72
极限1233291-23329191.55791.150.9995.9695.961.30
2231273-23127390.76595.43
3233214-23321491.52796.71
4232699-23269991.32496.50
5228185-22818589.55393.79
6234791-23479192.14697.34
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