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%
110.222999722995462990412991122994992994340.13
210.303009322991633000480.42
单位质量响应值RSD%判断
29298.8329130.870.41数据可信
供试品溶液-2025102721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%
5min135735-3573524.39526.508.1024.4026.508.10
243183-4318329.48029.48
337318-3731825.47625.48
435869-3586924.48724.49
538869-3886926.53526.53
641967-4196728.65028.65
10min179649-7964954.37455.872.7254.6556.162.74
284320-8432057.56357.89
379269-7926954.11554.40
480803-8080355.16255.43
582963-8296356.63756.93
684009-8400957.35157.67
15min194039-9403964.19865.912.0165.0766.832.04
297709-9770966.70367.67
394816-9481664.72865.61
495898-9589865.46766.35
597873-9787366.81567.74
698988-9898867.57668.53
20min1103674-10367470.77570.761.5472.3672.411.53
2105101-10510171.75073.46
3101966-10196669.60971.21
4104854-10485471.58173.19
5101478-10147869.27670.94
6104879-10487971.59873.30
30min1114506-11450678.17078.800.9180.5481.230.95
2116167-11616779.30481.81
3113939-11393977.78380.16
4115254-11525478.68181.09
5116087-11608779.24981.69
6116588-11658879.59182.09
45min1124480-12448084.97985.090.7888.2288.400.70
2123178-12317884.09087.48
3125619-12561985.75789.00
4125527-12552785.69488.98
5125124-12512485.41988.74
6123920-12392084.59787.98
60min1130610-13061089.16488.300.9693.3592.550.87
2127194-12719486.83291.15
3129838-12983888.63792.83
4129369-12936988.31792.55
5130253-13025388.92093.19
6128791-12879187.92292.25
90min1131530-13153089.79289.911.3694.9795.151.26
2128764-12876487.90493.19
3131816-13181689.98795.17
4134185-13418591.60496.82
5132621-13262190.53795.79
6131318-13131889.64794.95
120min1135811-13581192.71491.491.9798.8997.721.81
2129248-12924888.23494.50
3136947-13694793.49099.67
4134264-13426491.65897.89
5133982-13398291.46697.73
6133848-13384891.37497.67
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1135298-13529892.36492.170.8199.5799.420.77
2133115-13311590.87498.12
3134493-13449391.81599.03
4135870-13587092.755100.01
5135195-13519592.29499.57
6136083-13608392.900100.21
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%
110.222984972985542988922990573002772990550.25
210.303006672978552992610.67
单位质量响应值RSD%判断
29261.7429054.470.51数据可信
供试品溶液-2025102821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%
5min139084-3908426.73426.756.1426.7326.756.15
239656-3965627.12527.12
341897-4189728.65828.66
441197-4119728.17928.18
537309-3730925.51925.52
635483-3548324.27124.27
10min182300-8230056.29455.301.9056.5955.601.90
281277-8127755.59455.90
382462-8246256.40456.72
479715-7971554.52554.84
578489-7848953.68753.97
680869-8086955.31555.58
15min196784-9678466.20165.801.4367.1266.711.42
294678-9467864.76065.68
396458-9645865.97866.92
497024-9702466.36567.28
594401-9440164.57165.45
697876-9787666.94867.83
20min1107529-10752973.55071.142.8475.2172.792.79
2100077-10007768.45370.09
3103160-10316070.56272.24
4103600-10360070.86372.52
5102263-10226369.94871.55
6107447-10744773.49475.12
30min1115320-11532078.87978.891.5581.3581.321.53
2112435-11243576.90679.31
3115361-11536178.90781.37
4116326-11632679.56782.01
5114729-11472978.47580.85
6117807-11780780.58083.03
45min1124801-12480185.36484.832.7988.7288.142.69
2122181-12218183.57286.83
3124014-12401484.82688.17
4119011-11901181.40484.73
5124591-12459185.22188.47
6129508-12950888.58491.92
60min1128136-12813687.64688.392.3691.9592.642.29
2125820-12582086.06190.24
3128134-12813487.64491.93
4130904-13090489.53993.77
5127841-12784187.44491.64
6134470-13447091.97896.30
90min1128691-12869188.02589.302.1993.3094.532.13
2128164-12816487.66592.80
3129742-12974288.74494.00
4130990-13099089.59894.82
5129718-12971888.72893.89
6136025-13602593.04298.39
120min1130599-13059989.33090.332.2095.5896.562.14
2129270-12927088.42194.53
3130406-13040689.19895.44
4133307-13330791.18297.41
5131467-13146789.92496.07
6137311-13731193.921100.30
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1133315-13331591.18892.711.8898.4399.941.83
2133583-13358391.37198.47
3134913-13491392.28199.51
4135209-13520992.48399.72
5135865-13586592.932100.08
6140320-14032095.979103.40
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