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%
111.239770289756109751129793759763829767010.18
211.299770279760639765450.07
单位质量响应值RSD%判断
86972.4886496.460.39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%
5min1276088-27608828.57721.0922.7128.5821.0922.72
2245169-24516925.37725.38
3191796-19179619.85219.85
4160180-16018016.58016.58
5170529-17052917.65117.65
6178965-17896518.52418.52
10min1541084-54108456.00651.629.9556.3251.869.97
2555910-55591057.54057.82
3475243-47524349.19149.41
4466850-46685048.32248.51
5428292-42829244.33144.53
6525174-52517454.35954.56
15min1801073-80107382.91676.746.7283.8677.556.78
2788485-78848581.61382.53
3753834-75383478.02778.79
4695959-69595972.03672.76
5675531-67553169.92270.61
6733795-73379575.95276.76
20min1841556-84155687.10687.211.9288.9788.871.83
2826392-82639285.53787.36
3834949-83494986.42388.06
4828442-82844285.74987.27
5859250-85925088.93890.40
6864948-86494889.52891.18
30min1839459-83945986.88987.901.8189.7290.521.78
2845550-84555087.52090.30
3846037-84603787.57090.16
4849851-84985187.96590.44
5835443-83544386.47488.93
6878708-87870890.95293.60
45min1801537-80153782.96486.231.9586.7689.841.81
2842948-84294887.25091.00
3835530-83553086.48390.05
4839315-83931586.87490.33
5832853-83285386.20689.62
6846281-84628187.59591.25
60min1824389-82438985.32985.472.1990.0590.042.03
2811462-81146283.99188.71
3804128-80412883.23287.76
4820358-82035884.91289.33
5849243-84924387.90292.27
6844950-84495087.45892.09
极限1879206-87920691.00390.922.0296.6796.431.80
2862398-86239889.26494.92
3861381-86138189.15894.61
4893998-89399892.53497.89
5904452-90445293.61798.97
6868769-86876989.92395.53
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%
19.922530422521372529792520462526772525760.19
29.932526642528652527640.06
单位质量响应值RSD%判断
25461.2925454.580.02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%
5min135101-3510113.7499.9625.7013.759.9725.68
232264-3226412.63812.64
322383-223838.7688.77
419424-194247.6087.61
522252-222528.7168.72
621206-212068.3068.31
10min173709-7370928.87225.8113.8929.0225.9213.91
277738-7773830.45030.59
360678-6067823.76823.87
460300-6030023.62023.70
553750-5375021.05421.15
669219-6921927.11327.21
15min1115556-11555645.26441.058.0645.7441.458.14
2113961-11396144.63945.12
3101759-10175939.86040.22
495967-9596737.59137.94
596470-9647037.78838.12
6105104-10510441.17041.56
20min1126815-12681549.67448.593.6950.6549.443.73
2125005-12500548.96549.94
3118427-11842746.38847.19
4119778-11977846.91847.68
5123407-12340748.33949.09
6130785-13078551.22952.08
30min1131529-13152951.52151.955.8453.0553.355.76
2133156-13315652.15853.68
3125317-12531749.08750.41
4131615-13161551.55452.84
5126984-12698449.74051.03
6147166-14716657.64659.07
45min1127898-12789850.09852.776.7052.2054.746.54
2135616-13561653.12155.22
3127665-12766550.00751.87
4135908-13590853.23655.09
5129724-12972450.81452.65
6151539-15153959.35961.42
60min1133454-13345452.27554.158.7254.9356.718.42
2132150-13215051.76454.45
3123990-12399048.56750.99
4135762-13576253.17955.63
5145896-14589657.14859.55
6158194-15819461.96564.69
极限1175860-17586068.88570.562.2372.1273.712.24
2180390-18039070.66073.92
3175093-17509368.58571.55
4183067-18306771.70874.75
5181009-18100970.90273.94
6185322-18532272.59276.00
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