艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.203712423733093726253711713713233719340.27
214.313713603717983715790.09
单位质量响应值RSD%判断
26192.5425966.390.62数据可信
供试品溶液-B111406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%
5min1302833-30283380.18778.822.6280.1978.822.62
2289368-28936876.62176.62
3301890-30189079.93779.94
4290148-29014876.82876.83
5293440-29344077.70077.70
6308382-30838281.65681.66
10min1350723-35072392.86790.462.6093.0090.592.60
2334860-33486088.66788.79
3348946-34894692.39792.53
4332788-33278888.11988.25
5333097-33309788.20088.33
6349354-34935492.50592.64
15min1358407-35840794.90292.832.1795.1993.112.17
2348627-34862792.31292.59
3352070-35207093.22493.51
4341264-34126490.36390.64
5343452-34345290.94291.22
6359627-35962795.22595.52
20min1360708-36070895.51193.901.6095.9694.331.61
2353758-35375893.67194.10
3355114-35511494.03094.47
4347046-34704691.89492.32
5349883-34988392.64593.07
6361145-36114595.62796.08
30min1364974-36497496.64194.671.8597.2595.261.86
2352914-35291493.44894.03
3358449-35844994.91395.51
4350907-35090792.91693.49
5352090-35209093.22993.81
6365746-36574696.84597.45
45min1365080-36508096.66995.011.6697.4495.761.67
2353918-35391893.71394.45
3359844-35984495.28396.04
4353637-35363793.63994.37
5353766-35376693.67394.41
6366585-36658597.06897.84
60min1366390-36639097.01695.071.7197.9495.981.71
2354578-35457893.88894.79
3361026-36102695.59696.51
4353367-35336793.56894.46
5353166-35316693.51494.41
6365638-36563896.81797.75
极限1368873-36887397.67395.701.9598.7696.771.95
2355142-35514294.03895.09
3361864-36186495.81896.89
4355589-35558994.15695.20
5356199-35619994.31795.37
6370935-37093598.21999.31
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.203723083731063734363713123708223721970.31
214.313756793742313749550.28
单位质量响应值RSD%判断
26211.0626202.310.03数据可信
供试品溶液-B111406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%
5min1300419-30041979.16078.951.8479.1678.951.84
2308299-30829981.23681.24
3291885-29188576.91176.91
4297298-29729878.33878.34
5297803-29780378.47178.47
6302099-30209979.60379.60
10min1345146-34514690.94591.221.7691.0891.351.76
2351741-35174192.68392.82
3346212-34621291.22691.35
4339543-33954389.46989.60
5354481-35448193.40593.54
6339916-33991689.56789.70
15min1356745-35674594.00293.621.6694.2993.911.66
2358552-35855294.47894.77
3352625-35262592.91693.20
4349169-34916992.00592.29
5364710-36471096.10096.39
6350040-35004092.23592.52
20min1359083-35908394.61894.331.7395.0694.781.73
2360186-36018694.90895.36
3356000-35600093.80594.24
4352146-35214692.79093.22
5368542-36854297.11097.56
6352094-35209492.77693.21
30min1361304-36130495.20394.991.8295.8095.581.81
2359160-35916094.63895.24
3357783-35778394.27594.87
4353253-35325393.08293.67
5372652-37265298.19398.80
6358721-35872194.52295.11
45min1362093-36209395.41195.191.3696.1795.941.36
2361964-36196495.37796.14
3358043-35804394.34495.09
4354004-35400493.27994.02
5368598-36859897.12597.90
6362723-36272395.57796.32
60min1365059-36505996.19295.271.1897.1196.181.18
2360026-36002694.86695.79
3361260-36126095.19196.10
4355661-35566193.71694.61
5367642-36764296.87397.81
6359648-35964894.76795.67
极限1361695-36169595.30694.741.1396.3895.811.13
2360360-36036094.95496.03
3357752-35775294.26795.33
4353840-35384093.23694.29
5365687-36568796.35897.45
6357974-35797494.32695.39
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.203720373729753723853740893736553730280.23
214.313763673791173777420.52
单位质量响应值RSD%判断
26269.5826397.060.35数据可信
供试品溶液-Z005796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%
5min1191201-19120150.13952.7218.4350.1452.7218.43
2188388-18838849.40149.40
3209586-20958654.96054.96
4270301-27030170.88270.88
5163287-16328742.81942.82
6183458-18345848.10948.11
10min1329616-32961686.43688.221.3486.5288.311.35
2339348-33934888.98889.07
3335942-33594288.09588.19
4342973-34297389.93990.06
5335500-33550087.97988.05
6335197-33519787.90087.98
15min1348435-34843591.37193.081.2291.6093.321.21
2356651-35665193.52693.76
3353608-35360892.72892.97
4353483-35348392.69592.96
5361411-36141194.77494.99
6356225-35622593.41493.64
20min1354178-35417892.87794.611.4093.2695.001.39
2364751-36475195.65096.04
3358380-35838093.97994.37
4356808-35680893.56793.99
5366938-36693896.22396.60
6363658-36365895.36395.75
30min1358224-35822493.93894.640.9894.4795.190.96
2361830-36183094.88495.43
3358657-35865794.05294.60
4357506-35750693.75094.33
5366789-36678996.18496.72
6362391-36239195.03195.57
45min1359812-35981294.35494.930.9095.0595.630.88
2362689-36268995.10995.81
3361001-36100194.66695.37
4357394-35739493.72094.46
5365725-36572595.90596.60
6365376-36537695.81496.51
60min1359644-35964494.31094.600.6295.1695.470.61
2362475-36247595.05395.92
3358933-35893394.12494.99
4357933-35793393.86294.75
5362085-36208594.95195.81
6363509-36350995.32496.18
极限1360720-36072094.59394.420.5295.6095.440.50
2360087-36008794.42795.45
3361343-36134394.75695.78
4356380-35638093.45494.50
5361202-36120294.71995.73
6360685-36068594.58395.60
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.203715453711603706693727183707643713710.23
214.313756693737923747300.36
单位质量响应值RSD%判断
26152.8926186.580.10数据可信
供试品溶液-Z005796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%
5min1213967-21396756.46061.0515.3356.4661.0515.34
2176231-17623146.50246.50
3269891-26989171.21671.22
4219754-21975457.98757.99
5266154-26615470.23070.23
6242184-24218463.90563.91
10min1331536-33153687.48389.181.2587.5889.281.26
2338968-33896889.44489.52
3340527-34052789.85589.97
4334259-33425988.20188.30
5342736-34273690.43890.55
6339783-33978389.65989.77
15min1349338-34933892.18093.221.1892.4293.471.16
2361260-36126095.32695.55
3352362-35236292.97893.25
4351106-35110692.64792.89
5353269-35326993.21793.49
6352360-35236092.97793.23
20min1353611-35361193.30894.611.2893.7095.021.27
2366399-36639996.68297.07
3357397-35739794.30794.73
4355089-35508993.69894.10
5360786-36078695.20195.62
6357993-35799394.46494.87
30min1358941-35894194.71494.661.5395.2695.221.51
2369040-36904097.37997.93
3357907-35790794.44195.02
4354305-35430593.49194.04
5353976-35397693.40493.99
6358189-35818994.51595.08
45min1362383-36238395.62294.631.6396.3395.351.61
2368348-36834897.19697.91
3355182-35518293.72294.46
4354025-35402593.41794.13
5353403-35340393.25393.99
6358356-35835694.56095.29
60min1360076-36007695.01394.491.4095.8895.371.38
2367411-36741196.94997.82
3355807-35580793.88794.78
4355467-35546793.79794.66
5355532-35553293.81494.71
6354269-35426993.48194.36
极限1360868-36086895.22294.271.5896.2595.301.56
2366882-36688296.80997.84
3354123-35412393.44394.49
4351650-35165092.79093.81
5354192-35419293.46194.51
6355785-35578593.88194.92
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