达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.389966999252996459937399523994920.18
2 12.469984899819998340.03
单位质量响应值RSD%判断
8036.518012.360.22数据可信
供试品溶液-STLH批-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%
5min177428-7742877.57874.645.9777.5874.645.97
273657-7365773.80073.80
372534-7253472.67572.67
477422-7742277.57277.57
566939-6693967.06967.07
678968-7896879.12179.12
10min183941-8394184.10480.935.4584.2281.045.46
277955-7795578.10678.22
378603-7860378.75678.86
482463-8246382.62382.74
574856-7485675.00175.10
686799-8679986.96887.09
15min184929-8492985.09481.934.9085.3482.164.91
278652-7865278.80579.03
380041-8004180.19680.42
483291-8329183.45383.69
576609-7660976.75876.97
687109-8710987.27887.53
20min185972-8597286.13982.954.9086.5183.314.90
279802-7980279.95780.30
380991-8099181.14881.50
484228-8422884.39284.76
577511-7751177.66277.99
688243-8824388.41488.79
30min186813-8681386.98283.954.3887.4884.434.38
281039-8103981.19681.66
382348-8234882.50882.98
484817-8481784.98285.47
578993-7899379.14679.59
688715-8871588.88789.40
45min188164-8816488.33585.334.4488.9785.944.45
282671-8267182.83283.42
383677-8367783.83984.43
486410-8641086.57887.20
579911-7991180.06680.63
690138-9013890.31390.96
极限195959-9595996.14595.910.6196.9196.640.62
294810-9481094.99495.71
396339-9633996.52697.24
496163-9616396.35097.10
595273-9527395.45896.14
695793-9579395.97996.76
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.3810239499212991729874899201997451.50
2 12.469972099499996100.16
单位质量响应值RSD%判断
8056.957994.380.56数据可信
供试品溶液-STLH批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min174501-7450174.63574.803.8174.6474.803.81
270768-7076870.89570.90
376713-7671376.85176.85
478821-7882178.96378.96
574443-7444374.57774.58
672735-7273572.86672.87
10min181181-8118181.32782.423.6181.4482.543.61
279178-7917879.32179.43
384565-8456584.71784.83
487127-8712787.28487.40
580598-8059880.74380.86
680997-8099781.14381.25
15min183090-8309083.24084.323.2083.4784.563.20
281812-8181281.95982.18
386409-8640986.56586.81
488554-8855488.71488.96
582264-8226482.41282.65
682908-8290883.05783.29
20min183812-8381283.96385.103.2884.3285.463.28
282694-8269482.84383.19
386944-8694487.10187.47
489622-8962289.78390.17
582587-8258782.73683.09
684020-8402084.17184.53
30min185155-8515585.30886.063.0285.7986.563.02
283630-8363083.78184.25
387930-8793088.08888.59
490107-9010790.26990.79
583594-8359483.74584.23
685043-8504385.19685.68
45min186557-8655786.71387.182.9287.3387.802.93
285077-8507785.23085.83
388457-8845788.61689.25
491354-9135491.51992.17
584393-8439384.54585.15
686288-8628886.44387.05
极限198361-9836198.53897.730.8799.2898.480.86
296451-9645196.62597.35
396567-9656796.74197.51
497692-9769297.86898.66
597905-9790598.08198.81
698327-9832798.50499.24
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