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对照品来源自制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50
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%
110.222975022977702975072979182974972976390.07
210.302979652982012980830.06
单位质量响应值RSD%判断
29123.1928940.100.45数据可信
供试品溶液-2025102921批-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%
5min151335-5133535.26630.5916.9735.2730.5916.98
252777-5277736.25736.26
348325-4832533.19833.20
440701-4070127.96127.96
533210-3321022.81522.81
640823-4082328.04528.04
10min187519-8751960.12457.815.3860.5258.155.44
287400-8740060.04260.45
387474-8747460.09360.46
481690-8169056.12056.43
576209-7620952.35452.61
684606-8460658.12358.43
15min1101160-10116069.49568.202.5370.5569.182.62
2102196-10219670.20771.28
3100945-10094569.34770.38
497884-9788467.24468.18
595825-9582565.83066.67
697668-9766867.09668.05
20min1106456-10645673.13374.532.9474.9776.272.95
2110419-11041975.85677.71
3109948-10994875.53277.34
4110761-11076176.09177.77
5102865-10286570.66672.23
6110489-11048975.90477.61
30min1118298-11829881.26982.451.0483.9185.021.05
2120186-12018682.56685.26
3120698-12069882.91785.56
4120640-12064082.87785.40
5118744-11874481.57583.93
6121532-12153283.49086.04
45min1125150-12515085.97687.711.3889.5291.191.29
2127071-12707187.29590.91
3126736-12673687.06590.63
4129731-12973189.12392.57
5127770-12777087.77691.03
6129585-12958589.02292.50
60min1128851-12885188.51890.171.3993.0294.631.24
2129675-12967589.08493.66
3130494-13049489.64794.18
4132616-13261691.10595.54
5132937-13293791.32595.56
6132963-13296391.34395.81
90min1130706-13070689.79392.201.6495.2897.661.51
2134424-13442492.34797.92
3132534-13253491.04896.58
4135564-13556493.13098.58
5135465-13546593.06298.31
6136544-13654493.80399.28
120min1131007-13100789.99992.281.4696.4898.761.31
2133551-13355191.74798.34
3134490-13449092.39298.93
4135258-13525892.92099.40
5136874-13687494.030100.31
6134743-13474392.56699.09
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1136567-13656793.81995.321.64101.30102.831.45
2136919-13691994.061101.68
3139008-13900895.496103.07
4137682-13768294.585102.10
5142693-14269398.027105.35
6139638-13963895.929103.48
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对照品来源自制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50
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%
110.222985802984682980412984912983072983770.08
210.302966622971002968810.11
单位质量响应值RSD%判断
29195.4028823.400.91数据可信
供试品溶液-2024090421批-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%
5min127049-2704918.59717.5725.5018.6017.5725.50
235936-3593624.70724.71
329360-2936020.18620.19
419504-1950413.41013.41
522216-2221615.27415.27
619238-1923813.22713.23
10min177352-7735253.18252.464.3653.3952.654.43
282047-8204756.41056.68
375464-7546451.88452.11
472889-7288950.11350.26
576694-7669452.72952.90
673357-7335750.43550.58
15min191602-9160262.97962.962.7063.7863.742.74
294453-9445364.93965.84
390799-9079962.42763.23
493315-9331564.15764.86
591989-9198963.24564.00
687279-8727960.00760.71
20min1102063-10206370.17169.471.7771.6770.951.80
2103304-10330471.02572.65
398899-9889967.99669.49
4102425-10242570.42071.84
599582-9958268.46669.92
6100009-10000968.75970.13
30min1114666-11466678.83677.501.8481.1179.751.73
2110434-11043475.92778.34
3109885-10988575.54977.80
4114554-11455478.75980.96
5113604-11360478.10680.33
6113168-11316877.80679.94
45min1122922-12292284.51383.722.6487.6786.832.49
2117824-11782481.00784.26
3117830-11783081.01284.10
4125011-12501185.94989.02
5122377-12237784.13887.22
6124647-12464785.69888.70
60min1125811-12581186.49985.962.6290.5990.002.50
2123278-12327884.75788.91
3121841-12184183.76987.76
4131044-13104490.09794.13
5123183-12318384.69288.71
6125015-12501585.95289.91
90min1128790-12879088.54789.663.8793.6094.663.65
2124893-12489385.86890.97
3126833-12683387.20192.12
4138395-13839595.151100.18
5129186-12918688.81993.78
6134374-13437492.38697.30
120min1130742-13074289.88991.832.9295.9397.822.75
2129292-12929288.89294.94
3130266-13026689.56295.45
4137328-13732894.417100.51
5135681-13568193.28599.23
6138065-13806594.924100.86
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1130715-13071589.87093.382.0896.91100.401.94
2135224-13522492.970100.01
3135897-13589793.433100.32
4138865-13886595.474102.61
5136620-13662093.930100.92
6137613-13761394.613101.60
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