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500
标示量(mg)20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%
114.586643396615346646496634456644116636760.20
214.636647146622836634980.26
单位质量响应值RSD%判断
45519.6245351.880.27数据可信
长期30℃3月--供试品溶液-2025011021批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1244952-24495231.28428.529.1131.2828.529.11
2197694-19769425.24825.25
3225731-22573128.82928.83
4200774-20077425.64225.64
5243711-24371131.12531.13
6226976-22697628.98828.99
10min1516476-51647665.96159.978.2366.0160.028.23
2415931-41593153.12053.16
3469745-46974559.99360.04
4432071-43207155.18255.22
5492788-49278862.93662.99
6490367-49036762.62762.68
15min1697504-69750489.08183.465.4089.2483.615.40
2597600-59760076.32276.45
3650218-65021883.04283.19
4631940-63194080.70880.84
5671830-67183085.80285.96
6671855-67185585.80585.96
20min1772086-77208698.60695.862.0798.9296.152.07
2728335-72833593.01993.28
3762051-76205197.32597.61
4744306-74430695.05895.33
5742954-74295494.88695.19
6753751-75375196.26596.56
30min1797661-797661101.87299.892.15102.35100.342.14
2788279-788279100.674101.09
3797918-797918101.905102.35
4785847-785847100.364100.79
5758334-75833496.85097.31
6764845-76484597.68198.14
45min1790587-790587100.96999.642.01101.61100.262.00
2788017-788017100.641101.22
3798218-798218101.944102.56
4780862-78086299.727100.32
5756528-75652896.61997.24
6767017-76701797.95998.58
极限1791821-791821101.12799.352.43101.94100.132.42
2779356-77935699.535100.28
3803210-803210102.581103.37
4779095-77909599.501100.26
5751039-75103995.91896.70
6763132-76313297.46398.24
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500
标示量(mg)20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%
114.586644766635176635716638176646736640110.09
214.636659436628536643980.33
单位质量响应值RSD%判断
45542.5945413.400.21数据可信
长期30℃3月--供试品溶液-2025011121批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1256624-25662432.74431.206.1232.7431.206.12
2266582-26658234.01534.01
3237267-23726730.27430.27
4226377-22637728.88528.88
5234482-23448229.91929.92
6245859-24585931.37031.37
10min1534464-53446468.19564.934.4768.2564.984.47
2526408-52640867.16767.22
3515543-51554365.78165.83
4472802-47280260.32760.38
5492436-49243662.83262.88
6511678-51167865.28865.34
15min1700437-70043789.37287.893.2089.5488.053.20
2704470-70447089.88790.06
3696917-69691788.92389.08
4646836-64683682.53382.68
5682410-68241087.07287.23
6701880-70188089.55789.72
20min1805773-805773102.81398.643.25103.1398.943.26
2779847-77984799.50599.82
3777652-77765299.22599.53
4730334-73033493.18793.47
5762540-76254097.29697.60
6782098-78209899.792100.10
30min1786326-786326100.331100.511.80100.82100.981.80
2787803-787803100.520101.00
3784168-784168100.056100.53
4764076-76407697.49297.93
5799087-799087101.960102.42
6804815-804815102.691103.17
45min1783916-783916100.02499.941.69100.68100.581.70
2785686-785686100.250100.90
3783480-78348099.968100.61
4758644-75864496.79997.40
5798172-798172101.843102.47
6789597-789597100.749101.40
极限1785230-785230100.19299.621.66101.01100.431.66
2787246-787246100.449101.27
3776936-77693699.13399.94
4758328-75832896.75997.52
5796582-796582101.640102.44
6780405-78040599.576100.39
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500
标示量(mg)20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%
114.586655396646656608636604006600106622950.40
214.636651836625566638700.28
单位质量响应值RSD%判断
45424.9045377.310.08数据可信
长期30℃3月--供试品溶液-2025011221批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1230791-23079129.49830.964.8629.5030.964.86
2254164-25416432.48532.48
3247921-24792131.68731.69
4230597-23059729.47329.47
5255913-25591332.70932.71
6234196-23419629.93329.93
10min1491275-49127562.79064.272.0662.8464.322.06
2505878-50587864.65764.71
3508608-50860865.00665.06
4490904-49090462.74362.79
5517506-51750666.14366.20
6502849-50284964.27064.32
15min1664484-66448484.92887.021.5585.0887.171.56
2679061-67906186.79286.95
3683422-68342287.34987.51
4675607-67560786.35086.50
5695575-69557588.90289.07
6686735-68673587.77287.93
20min1749287-74928795.76797.801.2896.0698.111.29
2766059-76605997.91198.22
3764526-76452697.71598.02
4763333-76333397.56297.86
5779699-77969999.65499.97
6768481-76848198.22098.52
30min1770190-77019098.43999.291.0498.8999.761.03
2766671-76667197.98998.46
3781162-78116299.841100.31
4772909-77290998.78699.25
5785090-785090100.343100.82
6785263-785263100.365100.83
45min1768145-76814598.17799.141.0498.8099.771.04
2766011-76601197.90598.54
3781226-78122699.849100.49
4771660-77166098.62799.25
5783867-783867100.187100.83
6783183-783183100.099100.73
极限1761955-76195597.38698.531.0298.1799.331.02
2764825-76482597.75398.55
3772557-77255798.74199.54
4767197-76719798.05698.85
5775964-77596499.17799.99
6782980-782980100.074100.87
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