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%
112.129920899226992019919298972991600.11
212.209928399447993650.12
单位质量响应值RSD%判断
8181.528144.670.32数据可信
加速6月-供试品溶液-2025080621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%
5min187667-8766786.34586.410.8186.3586.410.81
287870-8787086.54586.55
388973-8897387.63287.63
487785-8778586.46286.46
587030-8703085.71885.72
687059-8705985.74785.75
10min193870-9387092.45592.630.7692.5892.750.76
293746-9374692.33392.46
395426-9542693.98894.12
494081-9408192.66392.79
593502-9350292.09392.22
693630-9363092.21992.35
15min195594-9559494.15394.521.0194.4294.781.01
295906-9590694.46094.73
397766-9776696.29296.56
496133-9613394.68494.95
595122-9512293.68893.95
695263-9526393.82794.09
20min196515-9651595.06095.571.2895.4795.981.27
297189-9718995.72496.13
399182-9918297.68798.10
497484-9748496.01496.43
595763-9576394.31994.73
696090-9609094.64195.05
30min197401-9740195.93396.781.3696.4897.331.35
298603-9860397.11797.67
3100536-10053699.02099.58
498758-9875897.26997.82
597166-9716695.70196.25
697105-9710595.64196.19
45min197941-9794196.46597.451.6197.1698.141.61
299519-9951998.01998.72
3101577-101577100.046100.76
499524-9952498.02498.72
597616-9761696.14496.84
697447-9744795.97896.67
极限197965-9796596.48897.491.4597.3398.331.45
299492-9949297.99298.84
3101363-10136399.835100.70
499542-9954298.04198.89
597802-9780296.32897.16
697714-9771496.24197.08
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%
112.129965899290992239926999319993520.18
212.2099892100089999900.14
单位质量响应值RSD%判断
8197.368195.900.02数据可信
加速6月-供试品溶液-2025080721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%
5min189619-8961987.90687.630.4187.9187.640.41
288795-8879587.09887.10
389477-8947787.76787.77
488981-8898187.28187.28
589657-8965787.94487.94
689519-8951987.80887.81
10min195932-9593294.09993.911.2094.2394.041.19
295271-9527193.45093.58
396266-9626694.42694.56
493790-9379091.99892.13
596016-9601694.18194.31
697182-9718295.32595.46
15min198262-9826296.38496.031.1696.6696.301.16
297502-9750295.63995.91
398862-9886296.97397.25
495780-9578093.95094.22
598487-9848796.60596.88
698488-9848896.60696.88
20min199421-9942197.52197.191.3797.9497.611.37
298674-9867496.78897.20
3100334-10033498.41798.84
496557-9655794.71295.12
599907-9990797.99898.42
699634-9963497.73098.15
30min1100551-10055198.63098.341.4299.1998.901.42
299515-9951597.61398.17
3101226-10122699.29299.86
497733-9773395.86596.42
5101462-10146299.523100.09
6101054-10105499.12399.69
45min1101266-10126699.33199.021.56100.0499.731.56
2100184-10018498.27098.98
3102137-102137100.185100.90
498118-9811896.24396.94
5102133-102133100.181100.90
6101876-10187699.929100.64
极限1101393-10139399.45599.031.59100.3299.891.58
2100366-10036698.44899.30
3101821-10182199.875100.74
497979-9797996.10796.95
5102137-102137100.185101.05
6102063-102063100.113100.98
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%
112.121006861006121003581003851004011004880.15
212.201001561001081001320.04
单位质量响应值RSD%判断
8291.098207.540.72数据可信
加速6月-供试品溶液-2025080722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%
5min190342-9034288.05288.150.9288.0588.150.92
289090-8909086.83286.83
391423-9142389.10689.11
490556-9055688.26188.26
591140-9114088.83088.83
690098-9009887.81487.81
10min194974-9497492.56793.601.2792.7093.731.27
294322-9432291.93192.06
397596-9759695.12295.26
496868-9686894.41394.54
596416-9641693.97294.11
696030-9603093.59693.73
15min197352-9735294.88495.371.2295.1695.641.21
296084-9608493.64893.92
399496-9949696.97497.25
498782-9878296.27896.55
597792-9779295.31395.59
697596-9759695.12295.39
20min198330-9833095.83796.181.2996.2596.601.29
296676-9667694.22594.63
3100454-10045497.90898.33
499541-9954197.01897.44
598518-9851896.02196.44
698570-9857096.07196.49
30min199129-9912996.61697.101.6397.1797.661.63
297008-9700894.54995.10
3101825-10182599.24499.81
4100601-10060198.05198.61
599224-9922496.70997.27
699944-9994497.41197.97
45min199287-9928796.77097.371.4797.4798.071.47
297726-9772695.24995.94
3102162-10216299.572100.29
4100573-10057398.02498.73
599612-9961297.08797.79
6100027-10002797.49198.20
极限199379-9937996.86097.251.5097.7198.111.49
297495-9749595.02495.86
3102027-10202799.441100.31
4100555-10055598.00698.86
599587-9958797.06397.91
699661-9966197.13597.99
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%
112.1299865999789993899910100297999980.18
212.20999141001521000330.17
单位质量响应值RSD%判断
8250.668199.430.45数据可信
加速6月-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%
5min193173-9317391.07890.611.0091.0890.621.00
292804-9280490.71790.72
392673-9267390.58990.59
493943-9394391.83091.83
591150-9115089.10089.10
692453-9245390.37490.37
10min199464-9946497.22796.321.0897.3696.461.07
297349-9734995.16095.30
399475-9947597.23897.37
499349-9934997.11597.25
598349-9834996.13796.27
697226-9722695.04095.18
15min1100092-10009297.84196.691.1798.1296.971.17
297717-9771795.52095.80
3100187-10018797.93498.22
499464-9946497.22797.51
598413-9841396.20096.48
697629-9762995.43495.71
20min1100213-10021397.95996.751.2498.3997.181.24
297753-9775395.55595.98
3100143-10014397.89198.32
499653-9965397.41297.84
598718-9871896.49896.92
697377-9737795.18795.61
30min1100150-10015097.89896.671.3398.4797.241.32
297695-9769595.49896.06
3100355-10035598.09898.67
499428-9942897.19297.77
598562-9856296.34696.91
697166-9716694.98195.54
45min1100109-10010997.85896.671.2598.5897.391.25
297346-9734695.15795.87
3100055-10005597.80598.53
499749-9974997.50698.23
598401-9840196.18896.90
697718-9771895.52196.23
极限199846-9984697.60196.361.2398.4797.221.22
297192-9719295.00695.86
399695-9969597.45398.32
499348-9934897.11497.98
598055-9805595.85096.71
697311-9731195.12395.97
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