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%
110.073124283098983095523096103093773101730.42
210.143088833094253091540.13
单位质量响应值RSD%判断
30801.6930488.560.73数据可信
供试品溶液-24032601批-pH4.5(内含0.45%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min119277-1927712.54616.0317.6312.5516.0317.62
227859-2785918.13118.13
330608-3060819.92019.92
423952-2395215.58815.59
520408-2040813.28213.28
625712-2571216.73416.73
10min165990-6599042.94844.962.3943.0945.142.43
270061-7006145.59745.80
370642-7064245.97546.20
469037-6903744.93145.10
569854-6985445.46345.61
668911-6891144.84945.03
15min181590-8159053.10155.352.8753.7256.032.88
288905-8890557.86158.57
384793-8479355.18555.92
484366-8436654.90755.58
586379-8637956.21756.87
684240-8424054.82555.51
20min189503-8950358.25160.972.4759.4662.262.47
293969-9396961.15762.51
394220-9422061.32062.67
493057-9305760.56461.85
596131-9613162.56463.84
695214-9521461.96763.26
30min1103497-10349767.35869.002.1269.2170.972.09
2106360-10636069.22171.25
3104610-10461068.08270.11
4109453-10945371.23473.19
5107667-10766770.07272.04
6104530-10453068.03070.01
45min1115421-11542175.11975.431.4777.7278.171.42
2115410-11541075.11177.91
3113430-11343073.82376.61
4116073-11607375.54378.29
5118659-11865977.22679.98
6116434-11643475.77878.52
60min1121151-12115178.84880.301.2682.2883.871.27
2123303-12330380.24883.88
3122648-12264879.82283.43
4123145-12314580.14583.73
5125756-12575681.84585.45
6124270-12427080.87884.46
极限1126442-12644282.29183.470.8586.6087.940.89
2128367-12836783.54488.07
3128359-12835983.53988.03
4127924-12792483.25687.73
5129768-12976884.45688.97
6128687-12868783.75288.23
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%
110.073110323085423084043083073089563090480.37
210.143091213092213091710.03
单位质量响应值RSD%判断
30689.9730490.240.47数据可信
供试品溶液-24032601批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min187468-8746857.02862.145.1457.0362.145.14
2100318-10031865.40665.41
395845-9584562.48962.49
492446-9244660.27360.27
595507-9550762.26962.27
6100283-10028365.38365.38
10min1218929-218929142.738145.131.69143.37145.821.70
2220189-220189143.559144.29
3226120-226120147.426148.12
4218833-218833142.675143.34
5224138-224138146.134146.83
6227339-227339148.221148.95
15min1257995-257995168.208169.221.27170.43171.521.27
2254204-254204165.737168.06
3263139-263139171.562173.89
4258576-258576168.587170.84
5261633-261633170.580172.90
6261723-261723170.639173.01
20min1278790-278790181.766182.341.17185.85186.521.16
2273715-273715178.457182.62
3283252-283252184.675188.91
4280795-280795183.073187.20
5281353-281353183.437187.65
6280083-280083182.609186.88
30min1300512-300512195.929196.250.90202.04202.460.88
2296959-296959193.612199.76
3303266-303266197.724204.01
4304674-304674198.642204.80
5300199-300199195.724201.97
6300397-300397195.854202.15
45min1311127-311127202.849203.061.28211.13211.451.22
2309961-309961202.089210.39
3312115-312115203.494211.98
4318925-318925207.934216.30
5308511-308511201.144209.57
6308050-308050200.843209.32
60min1312433-312433203.701203.941.45214.24214.591.38
2312298-312298203.613214.16
3312582-312582203.798214.55
4321357-321357209.519220.20
5308860-308860201.371212.03
6309291-309291201.652212.36
极限1312675-312675203.859203.751.30216.66216.661.24
2312166-312166203.527216.33
3312620-312620203.823216.84
4319875-319875208.553221.56
5308377-308377201.056213.95
6309335-309335201.681214.63
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