非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.143123873135533131033121603121153126640.21
211.203097703120183108940.52
单位质量响应值RSD%判断
28066.7927758.390.79数据可信
供试品溶液-25112403批-恩格列净-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%
5min134631-3463154.88435.2329.3854.8835.2329.37
220937-2093733.18133.18
318416-1841629.18629.19
421459-2145934.00934.01
515708-1570824.89424.89
622221-2222135.21635.22
10min156985-5698590.31180.8316.4990.9281.2216.49
242174-4217466.83867.21
355748-5574888.35088.67
457554-5755491.21391.59
538449-3844960.93561.21
655107-5510787.33587.73
15min157109-5710990.50790.942.2092.1292.242.33
256457-5645789.47490.59
357788-5778891.58392.89
459405-5940594.14695.54
555768-5576888.38289.34
657779-5777991.56992.93
20min156001-5600188.75190.791.6091.3793.091.56
257337-5733790.86992.97
356895-5689590.16892.49
458666-5866692.97595.41
556960-5696090.27192.21
657871-5787191.71594.09
30min155410-5541087.81590.491.8091.4293.801.69
256901-5690190.17893.29
357105-5710590.50193.83
457436-5743691.02694.50
557157-5715790.58393.52
658590-5859092.85496.25
45min154736-5473686.74787.851.5791.3392.161.64
254771-5477186.80290.92
355520-5552087.98992.32
456376-5637689.34693.83
554619-5461986.56190.51
656564-5656489.64494.07
60min153983-5398385.55387.601.4691.1092.891.42
255042-5504287.23292.31
355292-5529287.62892.94
456350-5635089.30494.78
555129-5512987.36992.28
655855-5585588.52093.95
极限151737-5173781.99490.806.8788.4997.076.42
257536-5753691.18497.23
355624-5562488.15494.44
463889-63889101.252107.72
557753-5775391.52897.41
657241-5724190.71797.13
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号250201对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.074109334117884115284108454102194110630.15
211.164076984102564089770.45
单位质量响应值RSD%判断
37133.0636646.680.94数据可信
供试品溶液-25112403批-非奈利酮-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%
5min118340-1834022.3738.26116.3322.378.26116.33
2-0.0000.00
311664-1166414.22914.23
4-0.0000.00
5-0.0000.00
610619-1061912.95412.95
10min157955-5795570.69953.9835.8470.9554.0735.92
226963-2696332.89232.89
357852-5785270.57470.73
451482-5148262.80362.80
521762-2176226.54726.55
649492-4949260.37560.52
15min164230-6423078.35473.0620.2579.3973.7520.40
253361-5336165.09565.46
369492-6949284.77385.72
468338-6833883.36684.06
538105-3810546.48446.78
665814-6581480.28681.10
20min166234-6623480.79980.8314.8182.7082.3415.00
264033-6403378.11479.20
373803-7380390.03291.92
473369-7336989.50391.13
547983-4798358.53459.35
672142-7214288.00689.71
30min169931-6993185.30988.539.6488.1190.949.87
273373-7337389.50891.46
377692-7769294.77697.66
476530-7653093.35995.98
559778-5977872.92374.39
678146-7814695.33098.01
45min173258-7325889.36790.986.3193.1294.366.67
274864-7486491.32794.28
376855-7685593.75597.69
477579-7757994.63998.29
565909-6590980.40282.67
678991-7899196.361100.11
60min173278-7327889.39291.983.8294.1496.384.22
275687-7568792.33196.30
376950-7695093.87198.85
477568-7756894.62599.33
570720-7072086.27189.44
678183-7818395.375100.19
极限170874-7087486.45995.665.8492.20101.085.51
278865-7886596.207101.20
376876-7687693.78199.80
484939-84939103.617109.38
579090-7909096.482100.61
679876-7987697.441103.32
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.143135343115133129213128033125503126640.24
211.203128683137673133180.21
单位质量响应值RSD%判断
28066.7927974.820.24数据可信
供试品溶液-25112403批-恩格列净-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%
5min143901-4390169.30451.9245.0569.3051.9245.05
214963-1496323.62123.62
312855-1285520.29420.29
443523-4352368.70868.71
542954-4295467.80967.81
639125-3912561.76561.76
10min159110-5911093.31477.6128.2594.0878.1828.35
239160-3916061.82062.08
325394-2539440.08840.31
454902-5490286.67187.43
556839-5683989.72990.48
659550-5955094.00994.70
15min159155-5915593.38587.339.7895.1988.7710.14
253426-5342684.34185.29
345421-4542171.70472.37
455767-5576788.03789.76
558171-5817191.83293.58
659975-5997594.68096.41
20min158675-5867592.62790.733.8295.4793.143.79
254004-5400485.25487.14
359871-5987194.51695.98
455890-5589088.23190.94
557396-5739690.60893.38
658995-5899593.13395.92
30min157686-5768691.06690.824.2194.9494.244.03
254086-5408685.38388.22
360945-6094596.21198.73
456434-5643489.09092.77
556612-5661289.37193.15
659429-5942993.81897.64
45min157369-5736990.56690.594.1895.4595.024.10
254471-5447185.99189.77
359528-5952893.97497.56
455694-5569487.92192.60
556425-5642589.07593.85
660821-6082196.015100.88
60min156749-5674989.58789.683.3695.4895.113.28
254070-5407085.35890.10
359219-5921993.48698.12
455328-5532887.34493.00
557049-5704990.06195.82
658425-5842592.23398.16
极限154990-5499086.81088.822.0193.7095.252.10
255524-5552487.65393.34
356357-5635788.96894.64
457036-5703690.04096.66
555619-5561987.80394.56
658041-5804191.62798.58
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号250201对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.074114644102904120134112254114654112910.16
211.164110834111294111060.01
单位质量响应值RSD%判断
37153.6636837.460.61数据可信
供试品溶液-25112403批-非奈利酮-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%
5min122510-2251027.38110.26102.1227.3810.26102.11
2-0.0000.00
3-0.0000.00
412898-1289815.68915.69
59784-978411.90111.90
65431-54316.6066.61
10min140181-4018148.87659.2452.7649.1859.3552.74
225186-2518630.63630.64
314475-1447517.60717.61
475103-7510391.35491.53
571076-7107686.45686.59
666178-6617880.49880.57
15min152383-5238363.71877.9429.1664.5778.7229.32
256475-5647568.69569.04
335872-3587243.63443.83
478769-7876995.81397.00
580123-8012397.46098.55
680848-8084898.34299.31
20min158563-5856371.23586.0915.9472.7987.7316.28
263306-6330677.00478.11
359905-5990572.86873.55
480168-8016897.51599.77
581896-8189699.617101.79
680808-8080898.294100.35
30min163165-6316576.83391.699.9679.1894.2910.19
269843-6984384.95686.92
376001-7600192.44693.94
480249-8024997.614100.95
580400-8040097.797101.08
682618-82618100.495103.65
45min167611-6761182.24194.368.0985.4497.978.32
273562-7356289.48092.38
378399-7839995.36397.88
479528-7952896.737101.16
580519-8051997.942102.31
685821-85821104.391108.66
60min169431-6943184.45593.485.6288.5798.145.90
273939-7393989.93893.84
378984-7898496.07599.65
478443-7844395.417100.91
580704-8070498.167103.62
679618-7961896.846102.28
极限176603-7660393.17994.381.1598.23100.081.80
278261-7826195.195100.09
376479-7647993.02897.67
478467-7846795.446102.00
577455-7745594.215100.76
678301-7830195.244101.75
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