氨溴酸替格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.716751696750506750576749366750206750460.02
214.766736166739006737580.03
单位质量响应值RSD%判断
45890.2845647.560.38数据可信
加速2月-供试品溶液-24041501-bz1批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1240318-24031830.46930.692.6730.4730.692.66
2246621-24662131.26831.27
3252464-25246432.00932.01
4236357-23635729.96629.97
5235648-23564829.87729.88
6240747-24074730.52330.52
10min1455840-45584057.79458.213.0157.8458.263.01
2473203-47320359.99560.05
3477879-47787960.58860.64
4448407-44840756.85156.90
5442719-44271956.13056.18
6456549-45654957.88357.93
15min1603689-60368976.53977.472.8376.6977.622.83
2629644-62964479.82979.98
3633443-63344380.31180.47
4604656-60465676.66176.81
5587977-58797774.54774.69
6606650-60665076.91477.06
20min1698655-69865588.57989.272.1588.8589.552.16
2720731-72073191.37891.66
3718692-71869291.11991.41
4708567-70856789.83690.11
5680334-68033486.25686.52
6697676-69767688.45588.73
30min1737759-73775993.53793.091.5093.9693.521.50
2744460-74446094.38694.82
3734333-73433393.10293.54
4745801-74580194.55694.98
5717531-71753190.97291.38
6725715-72571592.01092.43
45min1732843-73284392.91392.911.5693.4993.491.56
2741373-74137393.99594.59
3735351-73535193.23193.83
4747744-74774494.80395.38
5718285-71828591.06891.63
6721104-72110491.42592.00
极限1730078-73007892.56392.801.4293.3093.531.42
2739140-73914093.71294.46
3733846-73384693.04193.79
4746225-74622594.61095.35
5716848-71684890.88591.60
6725374-72537491.96692.70
氨溴酸替格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.716751006739296746186736326734896741540.11
214.766716596729206722900.14
单位质量响应值RSD%判断
45829.6445548.100.44数据可信
加速2月-供试品溶液-24041501-bz2批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1196242-19624224.92428.126.8024.9228.116.81
2241989-24198930.73430.73
3220155-22015527.96127.96
4227139-22713928.84828.85
5216780-21678027.53327.53
6225911-22591128.69228.69
10min1396457-39645750.35354.494.6650.3954.544.67
2453738-45373857.62857.68
3420300-42030053.38153.43
4438430-43843055.68455.73
5424436-42443653.90653.95
6440827-44082755.98856.04
15min1555021-55502170.49273.993.1770.6274.133.17
2607032-60703277.09777.24
3571825-57182572.62672.76
4595202-59520275.59575.74
5577448-57744873.34073.48
6588952-58895274.80174.94
20min1663256-66325684.23886.762.5884.4887.022.58
2705686-70568689.62789.90
3672671-67267185.43485.69
4702957-70295789.28189.55
5671311-67131185.26185.52
6682907-68290786.73487.00
30min1752145-75214595.52893.122.1495.9193.522.13
2738523-73852393.79894.22
3744318-74431894.53494.93
4730630-73063092.79593.21
5707610-70761089.87290.27
6725905-72590592.19592.61
45min1755119-75511995.90693.212.3396.4593.782.31
2739369-73936993.90594.49
3745641-74564194.70295.26
4729040-72904092.59393.16
5706012-70601289.66990.22
6728334-72833492.50493.07
极限1757479-75747996.20592.962.5896.9193.682.56
2735952-73595293.47194.21
3746839-74683994.85495.57
4723279-72327991.86292.59
5704583-70458389.48790.19
6723661-72366191.91092.63
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