非奈利酮卡格列净片项目信息
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D250501对照品来源原料对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
120.146538536545036550986549066546676546050.08
220.236553726550456552080.04
单位质量响应值RSD%判断
32502.7332387.940.26数据可信
供试品溶液-5122201批-非奈利酮-pH4.5(内含0.75%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1498522-49852269.07372.9414.4269.0772.9414.43
2539359-53935974.73274.73
3525530-52553072.81672.82
4590354-59035481.79781.80
5396012-39601254.87054.87
6608699-60869984.33984.34
10min1689907-68990795.59197.192.9995.7197.313.00
2680070-68007094.22894.35
3713356-71335698.84098.96
4723639-723639100.265100.40
5678786-67878694.05094.14
6722893-722893100.162100.30
15min1707230-70723097.99199.601.7498.2799.881.75
2706049-70604997.82898.11
3722524-722524100.110100.40
4727538-727538100.805101.11
5712170-71217098.67698.92
6737444-737444102.178102.49
20min1710606-71060698.459100.021.4598.90100.471.45
2715595-71559599.15099.60
3720190-72019099.787100.24
4726853-726853100.710101.18
5718062-71806299.49299.90
6740087-740087102.544103.02
30min1711267-71126798.551100.391.6499.15101.011.65
2717923-71792399.473100.08
3719504-71950499.692100.31
4727139-727139100.750101.39
5725676-725676100.547101.13
6745748-745748103.328103.98
45min1709755-70975598.341100.572.0399.11101.352.02
2716791-71679199.316100.09
3717317-71731799.389100.17
4723864-723864100.296101.10
5747867-747867103.622104.37
6739271-739271102.431103.25
60min1716181-71618199.232100.151.22100.16101.101.23
2718516-71851699.555100.50
3716197-71619799.234100.18
4721870-721870100.020100.99
5724487-724487100.382101.30
6739450-739450102.456103.45
极限1706128-70612897.83999.631.5698.93100.751.56
2713577-71357798.87199.98
3713092-71309298.80499.92
4721719-72171999.999101.14
5721514-72151499.970101.06
6738513-738513102.326103.49
非奈利酮卡格列净片项目信息
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101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.121633521163538216364211635513163547316352620.07
211.131635338163417416347560.06
单位质量响应值RSD%判断
147055.94146878.350.09数据可信
供试品溶液-5122201批-卡格列净-pH4.5(内含0.75%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1691771-69177141.47344.5820.3741.4744.5820.37
2630856-63085637.82137.82
31011354-101135460.63360.63
4605140-60514036.27936.28
5699153-69915341.91641.92
6823685-82368549.38249.38
10min11125616-112561667.48372.2712.6467.5572.3412.64
21072508-107250864.29964.36
31478328-147832888.62988.73
41199395-119939571.90671.97
51089189-108918965.29965.37
61267331-126733175.97976.06
15min11376134-137613482.50287.938.6782.6888.138.68
21335634-133563480.07480.24
31636315-163631598.10198.35
41537273-153727392.16392.34
51353703-135370381.15781.34
61561280-156128093.60293.81
20min11558140-155814093.41495.453.8593.7395.793.88
21538945-153894592.26392.57
31661904-166190499.635100.05
41638371-163837198.22498.56
51516901-151690190.94291.26
61638259-163825998.21798.58
30min11632056-163205697.84599.271.7498.3299.771.77
21634257-163425797.97798.43
31677189-1677189100.551101.13
41660467-166046799.549100.05
51630571-163057197.75698.22
61700351-1700351101.940102.47
45min11644521-164452198.593100.401.5599.23101.061.55
21661068-166106899.585100.21
31673502-1673502100.330101.08
41656993-165699399.340100.00
51706209-1706209102.291102.92
61705564-1705564102.252102.95
60min11660576-166057699.55599.801.14100.36100.631.16
21664585-166458599.796100.58
31671449-1671449100.207101.12
41651633-165163399.01999.85
51642350-164235098.46299.26
61697106-1697106101.745102.61
极限11633224-163322497.91599.201.3898.88100.201.40
21651765-165176599.02799.98
31663757-166375799.746100.83
41647289-164728998.75999.75
51636856-163685698.13399.10
61695383-1695383101.642102.68
非奈利酮卡格列净片项目信息
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D250501对照品来源原料对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
120.146564236547066559176557326560706557700.10
220.236523546519826521680.05
单位质量响应值RSD%判断
32560.5832237.670.71数据可信
供试品溶液-5122201批-非奈利酮-pH4.5(内含0.75%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1248967-24896734.54639.897.6034.5539.907.60
2309643-30964342.96542.97
3287539-28753939.89839.90
4278428-27842838.63438.63
5300853-30085341.74641.75
6299558-29955841.56641.57
10min1496618-49661868.90977.478.8468.9777.548.83
2533177-53317773.98274.05
3528620-52862073.35073.42
4596928-59692882.82882.89
5563310-56331078.16378.23
6631356-63135687.60587.67
15min1680373-68037394.40795.363.7294.5895.563.72
2656653-65665391.11591.31
3670504-67050493.03793.23
4707936-70793698.23198.43
5681690-68169094.58994.79
6726378-726378100.790101.01
20min1706376-70637698.01597.192.3898.3497.542.39
2678750-67875094.18194.53
3685006-68500695.05095.39
4707674-70767498.19598.56
5699884-69988497.11497.47
6724777-724777100.568100.95
30min1707673-70767398.19597.831.6298.6998.341.63
2692955-69295596.15396.66
3693912-69391296.28596.79
4707612-70761298.18698.72
5703884-70388497.66998.19
6724059-724059100.468101.02
45min1704986-70498697.82298.021.8398.4898.691.83
2696516-69651696.64797.31
3695375-69537596.48897.15
4706847-70684798.08098.77
5703679-70367997.64198.32
6730876-730876101.414102.13
60min1703015-70301597.54897.651.3598.3798.491.36
2696191-69619196.60297.43
3693786-69378696.26897.09
4707123-70712398.11898.98
5701936-70193697.39998.24
6720397-72039799.960100.85
极限1705034-70503497.82997.681.1298.8198.681.13
2703086-70308697.55898.54
3695949-69594996.56897.55
4700435-70043597.19098.21
5700409-70040997.18798.19
6718660-71866099.719100.77
非奈利酮卡格列净片项目信息
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101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.121662725163288316383121637310163862316419710.73
211.131628127162707516276010.05
单位质量响应值RSD%判断
147659.26146235.490.69数据可信
供试品溶液-5122201批-卡格列净-pH4.5(内含0.75%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11346940-134694080.76574.659.0680.7674.659.06
21340222-134022280.36280.36
31060897-106089763.61363.61
41193570-119357071.56871.57
51322606-132260679.30679.31
61205934-120593472.31072.31
10min11567520-156752093.99191.845.2294.1391.965.22
21602144-160214496.06796.20
31423247-142324785.34085.45
41511454-151145490.62990.75
51461255-146125587.61987.75
61623968-162396897.37697.50
15min11597870-159787095.81194.913.6796.1095.193.67
21650213-165021398.94999.24
31536348-153634892.12292.37
41541825-154182592.45092.72
51521608-152160891.23891.52
61649436-164943698.90399.19
20min11600330-160033095.95895.602.6196.4196.042.61
21631153-163115397.80798.27
31556248-155624893.31593.72
41572133-157213394.26894.69
51552418-155241893.08693.52
61653543-165354399.14999.60
30min11601011-160101195.99996.441.8596.6197.041.86
21632217-163221797.87098.49
31577411-157741194.58495.14
41583276-158327694.93695.52
51601958-160195896.05696.64
61654780-165478099.22399.84
45min11595684-159568495.68096.582.2796.4597.332.27
21631567-163156797.83198.62
31581273-158127394.81695.53
41589813-158981395.32896.07
51589561-158956195.31396.06
61675996-1675996100.495101.27
60min11591761-159176195.44596.681.8596.3797.601.85
21627564-162756497.59198.54
31578016-157801694.62095.49
41641092-164109298.40399.30
51588816-158881695.26896.17
61647293-164729398.77499.72
极限11602934-160293496.11596.681.2397.2097.751.24
21625373-162537397.46098.57
31587234-158723495.17396.20
41614258-161425896.79497.86
51601380-160138096.02197.08
61642758-164275898.50299.61
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