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250201对照品来源原料对照品使用方法直接使用
对照品含量(%)99.40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%
122.027509717526337506887513947528427517060.14
222.067673177683277678220.10
单位质量响应值RSD%判断
34137.4234806.071.38数据可信
供试品溶液-25091801批-非奈利酮-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%
5min1134647-13464717.47314.2723.3317.4714.2723.31
283440-8344010.82810.83
3111907-11190714.52214.52
10min190474-9047411.74112.547.5011.7712.577.45
2104635-10463513.57913.60
394890-9489012.31412.34
15min1345335-34533544.81437.6718.5044.8637.7218.49
2238045-23804530.89130.93
3287560-28756037.31737.36
20min1221313-22131328.72033.3323.6628.8433.4323.54
2326937-32693742.42742.52
3222156-22215628.82928.94
30min1450977-45097758.52454.079.2558.6954.239.22
2375032-37503248.66848.83
3424053-42405355.03055.18
45min1361439-36143946.90451.3315.2647.1751.5815.18
2465250-46525060.37660.62
3360002-36000246.71846.96
60min1508968-50896866.04963.675.4666.4064.015.43
2459919-45991959.68460.03
3503005-50300565.27565.60
极限1449837-44983758.37661.679.3558.8362.119.29
2526487-52648768.32368.77
3449235-44923558.29858.73
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c031-5250311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%
110.761694038169304116915611693118169779216939100.14
210.811729722173135417305380.07
单位质量响应值RSD%判断
157426.58160086.771.19数据可信
供试品溶液-25091801批-卡格列净-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%
5min1187449-18744910.6178.5723.9710.628.5723.98
2114950-1149506.5116.51
3151420-1514208.5768.58
10min1123393-1233936.9897.536.827.017.556.74
2141397-1413978.0088.02
3134304-1343047.6077.62
15min1465125-46512526.34422.8315.4626.3722.8515.45
2340530-34053019.28719.31
3403361-40336122.84522.87
20min1321447-32144718.20620.2616.5018.2820.3216.41
2425753-42575324.11424.17
3325807-32580718.45318.52
30min1576814-57681432.66930.926.4332.7731.026.41
2507797-50779728.76128.86
3553344-55334431.34031.44
45min1493508-49350827.95129.428.8328.1129.578.77
2572328-57232832.41532.56
3492303-49230327.88328.03
60min1552908-55290831.31631.587.2631.5231.787.20
2519564-51956429.42729.63
3600093-60009333.98834.18
极限1568830-56883032.21730.855.8432.4731.105.80
2556545-55654531.52131.77
3508710-50871028.81229.06
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250201对照品来源原料对照品使用方法直接使用
对照品含量(%)99.40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%
122.027694127685697692867709067702957696940.12
222.067740717745957743330.05
单位质量响应值RSD%判断
34954.3135101.220.30数据可信
供试品溶液-25091802批-非奈利酮-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%
5min1129190-12919016.49720.8740.2216.5020.8740.21
2121921-12192115.56915.57
3239218-23921830.54830.55
10min1175615-17561522.42627.8237.8522.4527.8637.86
2165094-16509421.08221.11
3312887-31288739.95540.01
15min1374441-37444147.81648.838.1247.8848.918.17
2356073-35607345.47045.53
3416615-41661553.20153.32
20min1402146-40214651.35454.187.6751.5054.357.72
2409122-40912252.24552.38
3461628-46162858.95059.16
30min1474052-47405260.53661.056.8960.7761.306.93
2447383-44738357.13057.35
3512812-51281265.48665.79
45min1492962-49296262.95164.993.8063.2865.353.85
2503542-50354264.30264.62
3530397-53039767.73168.14
60min1532263-53226367.97067.876.8068.4168.346.82
2495003-49500363.21263.64
3567207-56720772.43272.96
极限1546582-54658269.79871.252.3970.3571.832.44
2554715-55471570.83771.37
3572545-57254573.11473.76
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c031-5250311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%
110.761733342173381517368041738410173711317358970.13
210.811743835174747317456540.15
单位质量响应值RSD%判断
161328.72161485.110.07数据可信
供试品溶液-25091802批-卡格列净-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%
5min161000-610003.3983.2024.123.403.2024.17
242212-422122.3512.35
369256-692563.8583.86
10min158736-587363.2724.4525.813.284.4625.73
281134-811344.5194.52
399946-999465.5675.57
15min1239853-23985313.36112.407.6213.3712.427.58
2222275-22227512.38212.39
3205944-20594411.47211.49
20min1249751-24975113.91217.1416.8113.9517.1816.76
2349153-34915319.44919.48
3324224-32422418.06118.10
30min1384755-38475521.43220.922.1421.4920.982.11
2370958-37095820.66420.73
3370717-37071720.65020.72
45min1413442-41344223.03024.796.7423.1224.896.73
2448691-44869124.99425.09
3473041-47304126.35026.45
60min1478872-47887226.67526.920.7826.8127.060.80
2485628-48562827.05127.19
3485106-48510627.02227.17
极限1511817-51181728.51026.977.6928.6927.167.64
2441904-44190424.61624.80
3499037-49903727.79827.99
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250201对照品来源原料对照品使用方法直接使用
对照品含量(%)99.40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%
122.027681257676987675967687367683757681060.07
222.067776087772717774400.04
单位质量响应值RSD%判断
34882.2035242.070.73数据可信
供试品溶液-25091803批-非奈利酮-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%
5min168206-682068.7027.3916.308.707.3916.28
255848-558487.1257.12
349670-496706.3376.34
10min164537-645378.2337.6723.828.257.6923.83
271753-717539.1549.17
344140-441405.6315.64
15min1182321-18232123.26021.657.3523.2921.687.36
2169439-16943921.61721.64
3157388-15738820.07920.10
20min1176951-17695122.57521.6813.5922.6421.7413.57
2188742-18874224.07924.14
3144191-14419118.39518.45
30min1327656-32765641.80139.455.1941.9139.555.19
2298544-29854438.08738.19
3301512-30151238.46638.55
45min1306364-30636439.08538.5910.7239.2638.7610.71
2332848-33284842.46442.63
3268350-26835034.23534.38
60min1443071-44307156.52653.724.9456.7753.954.93
2401733-40173351.25251.49
3418410-41841053.37953.58
极限1418571-41857153.40052.288.6953.7352.598.66
2440138-44013856.15156.47
3370643-37064347.28547.58
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c031-5250311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%
110.761729235172899617292641732401173054717300890.09
210.811752902175216617525340.03
单位质量响应值RSD%判断
160788.94162121.550.59数据可信
供试品溶液-25091803批-卡格列净-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%
5min1155655-1556558.6687.879.428.677.879.45
2138921-1389217.7367.74
3129361-1293617.2047.20
10min1145004-1450048.0757.6812.548.097.6912.55
2150361-1503618.3738.39
3118121-1181216.5786.59
15min1296229-29622916.49615.685.6316.5215.705.61
2283487-28348715.78715.81
3264757-26475714.74414.77
20min1293758-29375816.35915.6311.0716.4115.6811.03
2303091-30309116.87916.93
3245261-24526113.65813.71
30min1457454-45745425.47525.031.5725.5625.111.58
2446541-44654124.86724.95
3444345-44434524.74524.82
45min1455933-45593325.39024.447.3225.5224.567.32
2458962-45896225.55925.68
3401890-40189022.38122.49
60min1428326-42832623.85325.357.6624.0225.517.63
2494610-49461027.54427.71
3442753-44275324.65624.80
极限1449294-44929425.02024.574.8725.2324.774.80
2416832-41683223.21323.42
3457436-45743625.47425.66
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250201对照品来源原料对照品使用方法直接使用
对照品含量(%)99.40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%
122.027713197701157704407709457718467709330.09
222.067655547657147656340.02
单位质量响应值RSD%判断
35010.5834706.890.62数据可信
供试品溶液批-非奈利酮-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%
5min1139443-13944317.89319.517.2217.8919.517.23
2159187-15918720.42720.43
3157580-15758020.22120.22
10min1344405-34440544.19444.783.5844.2244.813.59
2339464-33946443.56043.59
3363110-36311046.59446.63
15min1498194-49819463.92862.504.6764.0362.604.66
2460907-46090759.14459.25
3502011-50201164.41864.53
20min1594400-59440076.27473.505.4876.4873.715.48
2536774-53677468.87969.08
3587100-58710075.33775.56
30min1680588-68058887.33383.385.6387.6783.715.62
2609373-60937378.19578.51
3659322-65932284.60484.95
45min1715786-71578691.85088.095.0292.3388.565.02
2648541-64854183.22183.67
3695204-69520489.20989.69
60min1730192-73019293.69889.944.7694.3390.564.75
2664652-66465285.28885.88
3707816-70781690.82791.46
极限1735553-73555394.38692.891.7795.1893.671.79
2710214-71021491.13591.87
3725997-72599793.16093.95
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c031-5250311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%
110.761737053173448417367101736900173697317364240.07
210.811726097172640817262520.02
单位质量响应值RSD%判断
161377.70159690.290.75数据可信
供试品溶液批-卡格列净-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%
5min1129684-1296847.2638.0639.107.268.0639.10
2205956-20595611.53511.54
396156-961565.3865.39
10min1306449-30644917.16418.3519.0717.1818.3619.08
2397835-39783522.28222.30
3278425-27842515.59415.60
15min1418392-41839223.43323.444.4623.4723.484.50
2437202-43720224.48724.54
3399909-39990922.39822.43
20min1453458-45345825.39724.995.3125.4825.085.25
2419823-41982323.51423.61
3465520-46552026.07326.15
30min1440374-44037424.66523.963.7324.7924.093.66
2409941-40994122.96023.10
3433267-43326724.26724.38
45min1414826-41482623.23423.222.3623.4023.382.32
2404588-40458822.66022.83
3424122-42412223.75423.91
60min1435396-43539624.38623.513.3024.5923.713.26
2409162-40916222.91623.13
3414735-41473523.22923.42
极限1405872-40587222.73222.790.3622.9723.030.38
2408587-40858722.88423.13
3406369-40636922.76022.99
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