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101566-202301对照品来源中检院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)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%
111.124153854145604143394148704144334147170.11
211.184149614149084149340.01
单位质量响应值RSD%判断
37294.6937113.950.35数据可信
供试品溶液-6031001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%
5min110436-1043612.61015.5523.2012.6115.5623.19
211749-1174914.19714.20
310527-1052712.72012.72
418491-1849122.34322.34
512660-1266015.29815.30
613375-1337516.16116.16
10min127743-2774333.52336.3115.5833.6636.4915.61
227264-2726432.94433.10
326481-2648131.99832.14
439173-3917347.33447.58
529384-2938435.50635.68
630271-3027136.57736.76
15min137467-3746745.27348.3411.7545.7948.9111.82
239120-3912047.27047.79
335794-3579443.25143.75
449074-4907459.29860.07
538241-3824146.20846.77
640313-4031348.71249.30
20min144389-4438953.63757.3010.4754.6558.4110.52
250063-5006360.49361.54
341757-4175750.45651.43
455713-5571367.32068.75
544970-4497054.33955.42
647632-4763257.55558.68
30min157650-5765069.66069.708.7371.2771.458.73
264101-6410177.45579.18
350864-5086461.46163.00
462578-6257875.61577.80
553853-5385365.07266.75
657060-5706068.94870.71
45min167553-6755381.62780.696.0984.0183.216.12
272760-7276087.91890.50
362392-6239275.39077.61
470066-7006684.66387.68
563830-6383077.12879.53
664050-6405077.39479.93
60min176240-7624092.12387.783.5195.4291.203.57
273685-7368589.03692.59
369329-6932983.77386.83
474258-7425889.72893.69
570680-7068085.40588.67
671666-7166686.59689.99
90min180340-8034097.07896.021.83101.39100.411.86
280327-8032797.062101.61
379544-7954496.116100.11
479681-7968196.281101.24
576594-7659492.55196.76
680281-8028197.006101.36
120min180894-8089497.74797.800.99103.14103.260.88
279951-7995196.608102.23
381297-8129798.234103.29
480598-8059897.389103.42
580600-8060097.392102.63
682284-8228499.427104.86
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限181200-8120098.11796.771.24104.60103.321.26
279485-7948596.044102.74
378924-7892495.367101.52
479886-7988696.529103.64
579639-7963996.231102.55
681397-8139798.355104.89
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101566-202301对照品来源中检院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)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%
111.124140704136874137744140994142864139830.06
211.184154644157944156290.06
单位质量响应值RSD%判断
37228.6937176.120.10数据可信
供试品溶液-6031002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%
5min112335-1233514.90519.4427.9714.9119.4427.97
219263-1926323.27723.28
322299-2229926.94626.95
411998-1199814.49814.50
518501-1850122.35622.36
612105-1210514.62814.63
10min128749-2874934.74044.9225.8334.9145.1425.82
248207-4820758.25358.51
341929-4192950.66750.97
428846-2884634.85735.02
547022-4702256.82157.07
628280-2828034.17334.34
15min138457-3845746.47157.0120.6147.0257.7220.67
259635-5963572.06272.97
352519-5251963.46364.33
439479-3947947.70648.25
555217-5521766.72467.60
637756-3775645.62446.17
20min145915-4591555.48364.3216.7456.5565.6616.87
264743-6474378.23579.94
357795-5779569.83971.41
444947-4494754.31455.39
560751-6075173.41175.03
645204-4520454.62455.67
30min156626-5662668.42675.8812.4770.1177.9412.68
273088-7308888.31990.89
366012-6601279.76882.11
455018-5501866.48368.17
569765-6976584.30386.74
656250-5625067.97269.63
45min165054-6505478.61186.027.3081.0688.927.65
276767-7676792.76496.32
374520-7452090.04993.28
466933-6693380.88183.30
576135-7613592.00195.37
667690-6769081.79684.21
60min172820-7282087.99592.373.6891.3196.234.12
278079-7807994.35098.94
379073-7907395.55199.78
474818-7481890.40993.73
579531-7953196.104100.50
674319-7431989.80693.13
90min181147-8114798.05798.921.33102.35103.821.33
280955-8095597.825103.46
380987-8098797.864103.16
481648-8164898.663102.99
583220-83220100.562106.03
683233-83233100.578104.90
120min182735-8273599.97698.872.14105.36104.851.81
278965-7896595.421102.14
380544-8054497.329103.71
482544-8254499.745105.17
583776-83776101.234107.82
682332-8233299.489104.92
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限180273-8027397.00197.611.49103.50104.691.34
279300-7930095.825103.61
379658-7965896.258103.72
481467-8146798.444104.97
582255-8225599.396107.10
681695-8169598.719105.26
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