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 12.269866099061991389884199192989780.23
2 12.339945098847991480.44
单位质量响应值RSD%判断
8073.258041.200.29数据可信
供试品溶液-STGC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%
5min189024-8902488.83481.016.3188.8381.016.31
277591-7759177.42577.43
379487-7948779.31779.32
486141-8614185.95785.96
576728-7672876.56476.56
678136-7813677.96977.97
10min194021-9402193.82098.062.3393.9598.182.32
2100123-10012399.909100.03
398927-9892798.71698.83
497785-9778597.57697.71
5100211-10021199.997100.11
698544-9854498.33498.45
15min194044-9404493.84398.462.5994.1298.732.58
2100968-100968100.753101.02
399283-9928399.07199.34
497616-9761697.40897.68
5100572-100572100.357100.62
699562-9956299.35099.61
20min194040-9404093.83998.432.5094.2598.842.49
2100339-100339100.125100.54
399514-9951499.30299.72
497814-9781497.60598.03
5100673-100673100.458100.87
699463-9946399.25199.66
30min197570-9757097.36298.841.3397.9299.411.32
2100586-100586100.371100.94
399021-9902198.81099.37
497639-9763997.43198.00
5100473-100473100.259100.82
699036-9903698.82599.39
45min194152-9415293.95198.142.3694.6598.862.35
299934-9993499.721100.44
399380-9938099.16899.88
497168-9716896.96197.67
5100123-10012399.909100.63
699362-9936299.15099.86
极限193341-9334193.14297.962.6593.9898.822.64
2100375-100375100.161101.03
398695-9869598.48499.35
497572-9757297.36498.22
5100311-100311100.097100.96
698721-9872198.51099.37
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 12.269917199807995879895799626994300.36
2 12.339961499215994140.29
单位质量响应值RSD%判断
8110.118062.770.42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%
5min185107-8510784.61984.063.0084.6284.053.00
288499-8849987.99187.99
381270-8127080.80480.80
482326-8232681.85481.85
585121-8512184.63384.63
684920-8492084.43384.43
10min191652-9165291.12689.611.8691.2589.731.86
292406-9240691.87692.01
387994-8799487.48987.61
489213-8921388.70188.82
589126-8912688.61588.74
690343-9034389.82589.95
15min192638-9263892.10790.522.0892.3790.782.08
293593-9359393.05693.33
388304-8830487.79888.05
490212-9021289.69589.95
590292-9029289.77490.03
691213-9121390.69090.95
20min193151-9315192.61791.191.7393.0291.581.73
293615-9361593.07893.49
389496-8949688.98389.37
491341-9134190.81791.21
590482-9048289.96390.36
692189-9218991.66092.06
30min193765-9376593.22791.801.7793.7792.341.77
294374-9437493.83394.38
389979-8997989.46389.98
491729-9172991.20391.73
591362-9136290.83891.37
692774-9277492.24292.78
45min194596-9459694.05392.561.5694.7393.231.56
294563-9456394.02194.71
391142-9114290.61991.27
492119-9211991.59192.25
592278-9227891.74992.41
693873-9387393.33594.01
极限199194-9919498.62597.311.2299.4598.121.22
299134-9913498.56599.40
397691-9769197.13197.92
497674-9767497.11497.91
595983-9598395.43396.24
697547-9754796.98897.80
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 12.269830299163989889908399068989210.36
2 12.339908398597988400.35
单位质量响应值RSD%判断
8068.608016.220.47数据可信
供试品溶液-STGY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%
5min181742-8174281.71887.894.4481.7287.894.44
290278-9027890.25290.25
386304-8630486.27986.28
489191-8919189.16589.17
593117-9311793.09093.09
686859-8685986.83486.83
10min1101034-101034101.00599.501.04101.1399.631.04
298405-9840598.37798.51
398904-9890498.87599.00
4100569-100569100.540100.67
599134-9913499.10599.24
699143-9914399.11499.24
15min1101155-101155101.126100.120.91101.40100.400.91
299975-9997599.946100.23
399326-9932699.29799.58
4101406-101406101.377101.66
599552-9955299.52399.81
699465-9946599.43699.72
20min1101378-101378101.34999.621.28101.77100.051.27
299413-9941399.38499.82
399111-9911199.08299.51
4100783-100783100.754101.19
599394-9939499.36599.80
697818-9781897.79098.22
30min1101048-101048101.01999.870.81101.60100.450.81
299521-9952199.492100.07
399113-9911399.08499.66
4100694-100694100.665101.25
599171-9917199.14299.73
699857-9985799.828100.40
45min1101010-101010100.98199.660.78101.71100.390.78
298975-9897598.94699.68
399133-9913399.10499.83
4100197-100197100.168100.91
599353-9935399.324100.06
699461-9946199.432100.16
极限1100541-100541100.51299.540.92101.39100.420.92
299848-9984899.819100.70
398623-9862398.59599.47
4100639-100639100.610101.50
598587-9858798.55999.44
699182-9918299.153100.03
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