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%
114.326632096606236615866599256604676611620.20
214.326636286635356635820.01
单位质量响应值RSD%判断
46170.5346339.530.26数据可信
供试品溶液-24062001-2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%
5min1264676-26467633.20438.586.8733.2038.586.87
2313045-31304539.27239.27
3318277-31827739.92839.93
4318146-31814639.91239.91
5313657-31365739.34939.35
6317170-31717039.79039.79
10min1529461-52946166.42274.405.2866.4874.465.29
2609678-60967876.48576.55
3606463-60646376.08276.15
4607556-60755676.21976.29
5599961-59996175.26675.33
6605013-60501375.90075.97
15min1698206-69820687.59192.922.9187.7693.112.92
2752659-75265994.42394.62
3755550-75555094.78594.98
4748151-74815193.85794.05
5739241-73924192.73992.93
6750333-75033394.13194.32
20min1781463-78146398.03697.091.2098.3597.441.19
2764178-76417895.86896.22
3785259-78525998.51298.86
4777512-77751297.54097.89
5762453-76245395.65196.00
6772872-77287296.95897.31
30min1782073-78207398.11396.901.2398.5997.411.21
2764078-76407895.85596.37
3780692-78069297.93998.45
4779654-77965497.80998.32
5760743-76074395.43795.94
6767403-76740396.27296.78
45min1780661-78066197.93596.840.9798.5797.510.96
2765425-76542596.02496.69
3781366-78136698.02498.70
4771835-77183596.82897.50
5764905-76490595.95996.62
6767537-76753796.28996.96
极限1779525-77952597.79396.721.1698.6097.551.15
2762549-76254995.66396.49
3781441-78144198.03398.88
4774817-77481797.20298.04
5760146-76014695.36296.19
6767354-76735496.26697.10
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%
114.326670016653546656566668316648006659280.15
214.326665806668576667180.03
单位质量响应值RSD%判断
46503.3546558.520.09数据可信
供试品溶液-24062001-2批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1277440-27744034.59935.433.0234.6035.423.01
2290513-29051336.22936.23
3273082-27308234.05534.06
4284213-28421335.44435.44
5282539-28253935.23535.23
6296625-29662536.99136.99
10min1533421-53342166.52267.862.1066.5867.912.10
2547245-54724568.24668.31
3536492-53649266.90566.96
4535417-53541766.77166.83
5548767-54876768.43568.49
6563323-56332370.25170.31
15min1693883-69388386.53387.931.7386.7088.101.73
2706327-70632788.08488.26
3698151-69815187.06587.23
4693739-69373986.51586.68
5714543-71454389.10989.28
6723722-72372290.25490.43
20min1773434-77343496.45395.801.6996.7796.121.68
2773874-77387496.50896.83
3768290-76829095.81296.13
4742639-74263992.61392.93
5772573-77257396.34696.67
6778318-77831897.06297.39
30min1781041-78104197.40296.400.8897.8896.880.88
2775476-77547696.70897.19
3771355-77135596.19496.67
4761663-76166394.98595.45
5770726-77072696.11596.60
6777618-77761896.97597.47
45min1777261-77726196.93096.180.8297.5796.820.82
2773936-77393696.51697.16
3770189-77018996.04896.68
4759759-75975994.74895.37
5770473-77047396.08496.73
6775644-77564496.72997.38
极限1776626-77662696.85196.080.8397.6596.880.83
2774126-77412696.53997.34
3768044-76804495.78196.57
4758830-75883094.63295.42
5771887-77188796.26097.06
6773112-77311296.41397.23
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%
114.326617396625896608306609766609196614110.12
214.326592626603936598280.13
单位质量响应值RSD%判断
46187.9246077.370.17数据可信
供试品溶液-24062001-2批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1307449-30744938.67236.6415.4638.6736.6415.46
2308116-30811638.75638.76
3316355-31635539.79339.79
4310673-31067339.07839.08
5199697-19969725.11925.12
6305473-30547338.42438.42
10min1587602-58760273.91171.0612.1873.9871.1212.18
2592992-59299274.58974.65
3608885-60888576.58876.65
4582261-58226173.23973.30
5425737-42573753.55153.59
6592208-59220874.49174.55
15min1741910-74191093.32190.508.5693.5190.688.57
2735788-73578892.55192.74
3756321-75632195.13395.33
4742570-74257093.40493.59
5594561-59456174.78774.92
6745515-74551593.77493.96
20min1783053-78305398.49696.783.6798.8497.113.70
2773915-77391597.34697.69
3778478-77847897.92098.27
4784312-78431298.65499.00
5712374-71237489.60689.86
6784255-78425598.64798.99
30min1783432-78343298.54497.880.5399.0598.370.51
2773549-77354997.30097.81
3776904-77690497.72298.24
4773730-77373097.32397.83
5781289-78128998.27498.68
6780082-78008298.12298.63
45min1779877-77987798.09697.930.3298.7798.590.30
2774753-77475397.45298.12
3776395-77639597.65898.34
4779651-77965198.06898.74
5781325-78132598.27998.85
6779376-77937698.03398.71
极限1777992-77799297.85997.680.2898.6998.500.28
2772935-77293597.22398.05
3775437-77543797.53898.38
4778974-77897497.98398.82
5776805-77680597.71098.44
6777417-77741797.78798.62
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%
114.326586286584236583876574726569146579650.12
214.326594786595296595040.01
单位质量响应值RSD%判断
45947.2846054.750.17数据可信
供试品溶液-24062001-2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%
5min1279146-27914635.21333.1618.3935.2133.1618.39
2286806-28680636.17936.18
3296476-29647637.39937.40
4264225-26422533.33133.33
5284003-28400335.82535.83
6166610-16661021.01721.02
10min1556833-55683370.24166.5114.4470.3066.5614.44
2562539-56253970.96171.02
3578450-57845072.96873.03
4529603-52960366.80666.86
5560824-56082470.74570.80
6375345-37534547.34847.38
15min1725495-72549591.51786.6611.2191.6986.8211.22
2718535-71853590.63990.82
3726698-72669891.66991.85
4696192-69619287.82187.99
5723380-72338091.25091.43
6531562-53156267.05467.17
20min1784818-78481899.00095.537.0999.3395.847.11
2781264-78126498.55298.88
3767638-76763896.83397.17
4773070-77307097.51897.83
5788127-78812799.41899.75
6648857-64885781.85082.08
30min1784564-78456498.96898.271.0399.4698.741.04
2782205-78220598.67199.16
3766315-76631596.66697.16
4776850-77685097.99598.47
5788882-78888299.513100.01
6775336-77533697.80498.17
45min1781444-78144498.57598.141.0099.2398.770.98
2780693-78069398.48099.14
3763840-76384096.35497.01
4774862-77486297.74598.38
5785293-78529399.06099.72
6781955-78195598.63999.16
极限1784021-78402198.90097.941.1999.7298.741.17
2776917-77691798.00498.83
3760202-76020295.89596.72
4771879-77187997.36898.17
5783639-78363998.85299.68
6781726-78172698.61099.30
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